Trial Outcomes & Findings for Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (NCT NCT05366855)
NCT ID: NCT05366855
Last Updated: 2026-03-27
Results Overview
TERMINATED
PHASE3
42 participants
All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
2026-03-27
Participant Flow
Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner. Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab. Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
Participant milestones
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
8
|
5
|
0
|
1
|
4
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
8
|
0
|
0
|
1
|
4
|
9
|
Reasons for withdrawal
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
7
|
4
|
7
|
0
|
0
|
0
|
2
|
7
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Baseline characteristics by cohort
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=7 Participants
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
n=5 Participants
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
n=1 Participants
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=4 Participants
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
n=9 Participants
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
Total
n=42 Participants
Total of all reporting groups
|
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 Years
STANDARD_DEVIATION 18.36 • n=62 Participants
|
54.6 Years
STANDARD_DEVIATION 14.73 • n=123 Participants
|
41 Years
STANDARD_DEVIATION 12.21 • n=53 Participants
|
—
|
22 Years
STANDARD_DEVIATION NA • n=120 Participants
|
31.0 Years
STANDARD_DEVIATION 6.48 • n=18 Participants
|
32.3 Years
STANDARD_DEVIATION 13.78 • n=12 Participants
|
42.9 Years
STANDARD_DEVIATION 16.57 • n=6 Participants
|
45 Years
STANDARD_DEVIATION 15.71 • n=56 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=12 Participants
|
32 Participants
n=6 Participants
|
6 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=12 Participants
|
10 Participants
n=6 Participants
|
2 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
3 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=12 Participants
|
23 Participants
n=6 Participants
|
5 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=12 Participants
|
17 Participants
n=6 Participants
|
3 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
Malaysia
|
3 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=12 Participants
|
12 Participants
n=6 Participants
|
3 Participants
n=56 Participants
|
|
Region of Enrollment
Thailand
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
3 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=12 Participants
|
9 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=12 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
Morocco
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=56 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
Taiwan
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
|
Region of Enrollment
Tunisia
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
Georgia
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
GPPPGA Score at Baseline
Moderate (3)
|
7 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
3 Participants
n=18 Participants
|
8 Participants
n=12 Participants
|
33 Participants
n=6 Participants
|
5 Participants
n=56 Participants
|
|
GPPPGA Score at Baseline
Severe (4)
|
0 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=12 Participants
|
9 Participants
n=6 Participants
|
3 Participants
n=56 Participants
|
PRIMARY outcome
Timeframe: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.Population: No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
Outcome measures
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=7 Participants
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
n=5 Participants
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
n=1 Participants
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=4 Participants
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
n=9 Participants
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
8 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
Percentages are calculated using FCS imputation. The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Outcome measures
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=8 Participants
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
|
100 Percentage of subjects (%)
|
64.4 Percentage of subjects (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 until termination of studyPopulation: The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=8 Participants
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
|
NA Weeks
Not applicable as there were no events in the time-to-event analysis.
|
42.3 Weeks
Interval 4.1 to 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
Percentages are calculated using FCS imputation. GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear)
Outcome measures
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 Participants
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=8 Participants
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Zero Recurrence of GPP Flare
|
100.0 Percentage of subjects (%)
Interval 2.9 to 70.6
|
63.3 Percentage of subjects (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Serious adverse events
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 participants at risk
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=7 participants at risk
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 participants at risk
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
n=5 participants at risk
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
n=1 participants at risk
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=4 participants at risk
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
n=9 participants at risk
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
Other adverse events
| Measure |
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 participants at risk
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
n=7 participants at risk
Randomized to subcutaneous placebo Q4W
|
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=8 participants at risk
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
n=5 participants at risk
Any available therapy
|
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
n=1 participants at risk
Randomized to subcutaneous placebo SC Q4W
|
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
n=4 participants at risk
Open-label subcutaneous 200 mg imsidolimab Q4W
|
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
n=9 participants at risk
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
28.6%
2/7 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
100.0%
1/1 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
28.6%
2/7 • Number of events 5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
50.0%
2/4 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
33.3%
3/9 • Number of events 4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
28.6%
2/7 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
100.0%
1/1 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Infection
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
1/8 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
28.6%
2/7 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
50.0%
2/4 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
22.2%
2/9 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
22.2%
2/9 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Blood pressure increased
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
100.0%
1/1 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
100.0%
1/1 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
28.6%
2/7 • Number of events 6 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
100.0%
1/1 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
14.3%
1/7 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
22.2%
2/9 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Body tinea
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Furuncle
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Investigations
Troponin T increased
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
12.5%
1/8 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
11.1%
1/9 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
|
Infections and infestations
Viral rash
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/7 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/8 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
—
0/0 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place