Trial Outcomes & Findings for VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (NCT NCT05156125)
NCT ID: NCT05156125
Last Updated: 2026-04-30
Results Overview
The percentage of participants with clinical remission at Week 13. Clinical remission was based on the modified Mayo score (MMS), which is a composite score of participant-reported symptoms and endoscopies which were assessed by a central reader. Clinical remission was defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
Day 1 of Induction treatment period to Week 13
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
VTX002 60 mg Once Daily
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
73
|
70
|
|
Overall Study
Dosed in Long-Term Extension
|
33
|
37
|
25
|
|
Overall Study
Dosed in Open-Label Extension
|
62
|
67
|
61
|
|
Overall Study
Did Not Enter Long-Term or Open-Label Extension Following Induction
|
1
|
0
|
2
|
|
Overall Study
COMPLETED
|
67
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
Reasons for withdrawal
| Measure |
VTX002 60 mg Once Daily
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
Baseline Characteristics
VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
VTX002 60 mg Once Daily
n=70 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=73 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 13.81 • n=14 Participants
|
42.3 years
STANDARD_DEVIATION 15.01 • n=34 Participants
|
40.1 years
STANDARD_DEVIATION 13.78 • n=69 Participants
|
40.6 years
STANDARD_DEVIATION 14.21 • n=140 Participants
|
|
Age, Customized
18 to 44
|
49 Participants
n=14 Participants
|
41 Participants
n=34 Participants
|
46 Participants
n=69 Participants
|
136 Participants
n=140 Participants
|
|
Age, Customized
45 to 65
|
18 Participants
n=14 Participants
|
27 Participants
n=34 Participants
|
21 Participants
n=69 Participants
|
66 Participants
n=140 Participants
|
|
Age, Customized
>65
|
3 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
11 Participants
n=140 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=14 Participants
|
26 Participants
n=34 Participants
|
32 Participants
n=69 Participants
|
97 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=14 Participants
|
47 Participants
n=34 Participants
|
38 Participants
n=69 Participants
|
116 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
13 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=14 Participants
|
66 Participants
n=34 Participants
|
66 Participants
n=69 Participants
|
199 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=69 Participants
|
19 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=140 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=14 Participants
|
67 Participants
n=34 Participants
|
63 Participants
n=69 Participants
|
190 Participants
n=140 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Induction treatment period to Week 13Population: Full Analysis Set - Baseline Modified Mayo Score 5-9
The percentage of participants with clinical remission at Week 13. Clinical remission was based on the modified Mayo score (MMS), which is a composite score of participant-reported symptoms and endoscopies which were assessed by a central reader. Clinical remission was defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=68 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=71 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Clinical Remission at 13 Weeks
|
19 Participants
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Induction Treatment Period to Week 13Population: Full Analysis Set - Baseline MMS 5 to 9
The percentage of participants with endoscopic improvement at Week 13. Endoscopic improvement was assessed from endoscopies assessed by a central reader. Endoscopic improvement was defined as ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=68 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=71 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Endoscopic Improvement at Week 13
|
25 Participants
|
23 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Induction Treatment Period to Week 13Population: Full analysis set - Baseline MMS 5 to 9
The percentage of participants with symptomatic remission at Week 13. Symptomatic remission was measured using participant-reported symptoms and was defined as SF subscore = 0 or 1 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=68 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=71 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Symptomatic Remission at Week 13
|
29 Participants
|
29 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Induction Treatment Period to Week 13Population: Full analysis set - Baseline MMS 5 to 9
The percentage of participants with histologic remission at Week 13. Histologic remission was assessed using the Geboes Index score and defined for this outcome measure as a Geboes score \< 2.0. The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=68 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=71 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Histologic Remission at Week 13
|
13 Participants
|
20 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Induction Treatment Period to Week 13Population: Full Analysis Set - Baseline MMS 5 to 9
The percentage of participants with endoscopic improvement-histologic remission at Week 13. This outcome measure was assessed by endoscopic histologic scores and defined as ES ≤ 1 (excluding friability) and a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=68 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=71 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
n=70 Participants
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
Endoscopic Improvement-Histologic Remission at Week 13
|
7 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 8, and 13 of the Induction Treatment PeriodPopulation: The Pharmacokinetics Set consisted of all participants who received VTX002 and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for VTX002.
Plasma concentrations of VTX002 in samples obtained predose at Weeks 1, 4, 8, and 13 in the Induction Treatment Period
Outcome measures
| Measure |
VTX002 60 mg Once Daily
n=70 Participants
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily
n=73 Participants
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily
Placebo tablet administered orally once daily
|
|---|---|---|---|
|
PK of VTX002
Week 13
|
1050 ng/mL
Standard Deviation 930.15
|
444.2 ng/mL
Standard Deviation 341.13
|
—
|
|
PK of VTX002
Week 1
|
640.8 ng/mL
Standard Deviation 378.77
|
363.2 ng/mL
Standard Deviation 237.79
|
—
|
|
PK of VTX002
Week 4
|
911.5 ng/mL
Standard Deviation 777.40
|
374.7 ng/mL
Standard Deviation 242.93
|
—
|
|
PK of VTX002
Week 8
|
935.1 ng/mL
Standard Deviation 718.16
|
393.2 ng/mL
Standard Deviation 251.98
|
—
|
Adverse Events
VTX002 60 mg Once Daily (Induction Period)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
VTX002 30 mg Once Daily (Induction Period)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Once Daily (Induction Period)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
VTX002 60 mg Once Daily (Long-Term Extension Period)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VTX002 30 mg Once Daily (Long-Term Extension Period)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Once Daily (Long-Term Extension Period)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
VTX002 60 mg Once Daily (Open-Label Extension Period)
Serious events: 8 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VTX002 60 mg Once Daily (Induction Period)
n=70 participants at risk
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily (Induction Period)
n=73 participants at risk
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily (Induction Period)
n=70 participants at risk
Placebo tablet for VTX002 administered orally once daily
|
VTX002 60 mg Once Daily (Long-Term Extension Period)
n=33 participants at risk
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily (Long-Term Extension Period)
n=37 participants at risk
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily (Long-Term Extension Period)
n=25 participants at risk
Placebo tablet for VTX002 administered orally once daily
|
VTX002 60 mg Once Daily (Open-Label Extension Period)
n=190 participants at risk
VTX002 60 mg tablet administered orally once daily
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
4.0%
1/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.6%
3/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
4.0%
1/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
2.7%
1/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
2.7%
1/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.53%
1/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
Other adverse events
| Measure |
VTX002 60 mg Once Daily (Induction Period)
n=70 participants at risk
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily (Induction Period)
n=73 participants at risk
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily (Induction Period)
n=70 participants at risk
Placebo tablet for VTX002 administered orally once daily
|
VTX002 60 mg Once Daily (Long-Term Extension Period)
n=33 participants at risk
VTX002 60 mg tablet administered orally once daily
|
VTX002 30 mg Once Daily (Long-Term Extension Period)
n=37 participants at risk
VTX002 30 mg tablet administered orally once daily
|
Placebo Once Daily (Long-Term Extension Period)
n=25 participants at risk
Placebo tablet for VTX002 administered orally once daily
|
VTX002 60 mg Once Daily (Open-Label Extension Period)
n=190 participants at risk
VTX002 60 mg tablet administered orally once daily
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
6/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.0%
1/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
6.3%
12/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Nervous system disorders
Headache
|
5.7%
4/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
6.8%
5/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
2.9%
2/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
5.3%
10/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
5.5%
4/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
8.6%
6/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.0%
1/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
2.7%
1/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.2%
6/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
6.1%
2/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
10.8%
4/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.7%
7/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
6.1%
2/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
5.4%
2/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.2%
6/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Investigations
Aspartate animotransferase increased
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
6.1%
2/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
2.6%
5/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
5.4%
2/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.1%
2/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
4.3%
3/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
5.4%
2/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
4.0%
1/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
3.2%
6/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.9%
2/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
28.9%
55/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
1.4%
1/73 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
4.3%
3/70 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/33 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/37 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
0.00%
0/25 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
7.4%
14/190 • From the signing of the Informed Consent Form through 30 days after the last study treatment, up to 13 weeks in the Induction Treatment Period, up to 39 weeks in the Long-Term Extension Treatment Period, and up to 143 weeks in the Open-Label Extension Treatment Period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60