Trial Outcomes & Findings for Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor (NCT NCT05198310)
NCT ID: NCT05198310
Last Updated: 2025-07-22
Results Overview
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade \[Gr\] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
From first dose of study drug to 24 weeks
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk)
KPL-404 2 mg/kg subcutaneous (SC) q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
Placebo SC q2wk for 12 weeks
(Per protocol, placebo arms for Cohorts 1 and 2 were combined for analysis.)
|
Cohort 3 KPL-404 5 mg/kg Qwk
KPL-404 5 mg/kg SC once weekly (qwk) for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg q2wk
KPL-404 5 mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC every 4 weeks (q4wk) for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
27
|
25
|
26
|
31
|
20
|
|
Overall Study
COMPLETED
|
6
|
5
|
4
|
25
|
25
|
24
|
30
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
0
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk)
KPL-404 2 mg/kg subcutaneous (SC) q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
Placebo SC q2wk for 12 weeks
(Per protocol, placebo arms for Cohorts 1 and 2 were combined for analysis.)
|
Cohort 3 KPL-404 5 mg/kg Qwk
KPL-404 5 mg/kg SC once weekly (qwk) for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg q2wk
KPL-404 5 mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC every 4 weeks (q4wk) for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
2
|
1
|
3
|
Baseline Characteristics
Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Baseline characteristics by cohort
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg Qwk
n=27 Participants
KPL-404 5 mg/kg SC qwk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg q2wk
n=25 Participants
KPL-404 5 mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
|
Cohort 3 Placebo
n=26 Participants
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 15.59 • n=99 Participants
|
56.3 years
STANDARD_DEVIATION 13.29 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 13.05 • n=206 Participants
|
58.5 years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 10.10 • n=31 Participants
|
57.6 years
STANDARD_DEVIATION 9.90 • n=30 Participants
|
58.8 years
STANDARD_DEVIATION 9.45 • n=3 Participants
|
58.3 years
STANDARD_DEVIATION 11.81 • n=6 Participants
|
58.5 years
STANDARD_DEVIATION 10.34 • n=114 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
25 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
120 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
25 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
121 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
130 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to 24 weeksPopulation: Safety Population: All randomized participants who received at least one dose of study drug.
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade \[Gr\] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs by maximum severity
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Maximum Severity = Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Maximum Severity = Moderate
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Maximum Severity = Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Maximum Severity = Fatal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to dose interruption
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Maximum Severity = Potentially life threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs of special interest
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Injection site reactions
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-related TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 (Dose 1) and 57 (Dose 4)Population: Participants treated with KPL-404, with an evaluable PK sample at given time point.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=5 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Day 1
|
7.57 µg/mL
Standard Deviation 7.52
|
28.0 µg/mL
Standard Deviation 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Day 57
|
17.8 µg/mL
Standard Deviation 13.9
|
68.3 µg/mL
Standard Deviation 25.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 (Dose 1) and 57 (Dose 4)Population: Participants treated with KPL-404, with an evaluable PK sample at given time point.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=5 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Area Under the Serum Concentration-time Curve From Time of Administration to the End of the Dosing Interval, (AUCtau)
Day 1
|
59.0 µg·day/mL
Standard Deviation 51.1
|
303 µg·day/mL
Standard Deviation 148
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 1 and 2: Area Under the Serum Concentration-time Curve From Time of Administration to the End of the Dosing Interval, (AUCtau)
Day 57
|
162 µg·day/mL
Standard Deviation 114
|
810 µg·day/mL
Standard Deviation 290
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent-to-Treat (mITT) population: All randomized participants who received at least one dose of study drug and who had at least one post-baseline assessment for the primary efficacy endpoint.
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score \< 2.6, low disease activity = score \< 3.2). A negative value in change from BL indicates an improvement.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=27 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=25 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=26 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 3 and 4: Change From Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12
|
-2.17 score on a scale
Standard Error 0.216
|
-1.96 score on a scale
Standard Error 0.220
|
-1.61 score on a scale
Standard Error 0.218
|
-1.87 score on a scale
Standard Error 0.331
|
-1.30 score on a scale
Standard Error 0.338
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT Population: All randomized participants who received at least one dose of study drug and who had at least one post-baseline assessment for the primary efficacy endpoint.
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score \< 2.6, low disease activity = score \< 3.2). A negative value in change from BL indicates an improvement.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Change From Baseline in DAS28-CRP at Week 12
|
-3.16 score on a scale
Standard Deviation 1.130
|
-3.44 score on a scale
Standard Deviation 1.450
|
-1.09 score on a scale
Standard Deviation 1.373
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to 24 weeksPopulation: Safety Population: All randomized participants who received at least one dose of study drug.
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade \[Gr\] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=27 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=25 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=26 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs by maximum severity
|
12 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Maximum Severity = Potentially life threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Injection site reactions
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs
|
12 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Drug-related TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Maximum Severity = Mild
|
8 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Maximum Severity = Moderate
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Maximum Severity = Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Maximum Severity = Fatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
Drug-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs leading to dose interruption
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Cohorts 3 and 4: Number of Participants With TEAEs
TEAEs of special interest
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Dose 1) and 57 (Dose 4 or 8)Population: Participants treated with KPL-404, with an evaluable PK sample at given time point.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=27 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=25 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=30 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 3 and 4: Cmax
Day 1
|
27.1 µg/mL
Standard Deviation 11.0
|
29.4 µg/mL
Standard Deviation 10.3
|
48.5 µg/mL
Standard Deviation 18.2
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3 and 4: Cmax
Day 57
|
145 µg/mL
Standard Deviation 41.0
|
70.9 µg/mL
Standard Deviation 21.5
|
45.6 µg/mL
Standard Deviation 21.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Dose 1) and 57 (Dose 4 or 8)Population: Participants treated with KPL-404, with an evaluable PK sample at given time point.
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=27 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=25 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=30 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 3 and 4: AUCtau
Day 1
|
139 µg·day/mL
Standard Deviation 63.4
|
310 µg·day/mL
Standard Deviation 105
|
873 µg·day/mL
Standard Deviation 363
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3 and 4: AUCtau
Day 57
|
975 µg·day/mL
Standard Deviation 291
|
849 µg·day/mL
Standard Deviation 267
|
843 µg·day/mL
Standard Deviation 466
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT population: All randomized participants who received at least one dose of study drug and who had at least one post-baseline assessment for the primary efficacy endpoint.
An ACR20 response is defined as at least a 20% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 20% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure \[Health Assessment Questionnaire (HAQ)\], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=27 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=25 Participants
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
n=26 Participants
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
|
100 percentage of participants
|
83.3 percentage of participants
|
25.0 percentage of participants
|
74.1 percentage of participants
|
60.0 percentage of participants
|
50.0 percentage of participants
|
80.6 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT population: All randomized participants who received at least one dose of study drug and who had at least one post-baseline assessment for the primary efficacy endpoint.
An ACR50 response is defined as at least a 50% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 50% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure \[Health Assessment Questionnaire (HAQ)\], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=27 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=25 Participants
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
n=26 Participants
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
|
66.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
36.0 percentage of participants
|
23.1 percentage of participants
|
32.3 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT population: All randomized participants who received at least one dose of study drug and who had at least one post-baseline assessment for the primary efficacy endpoint.
An ACR70 response is defined as at least a 70% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 70% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure \[Health Assessment Questionnaire (HAQ)\], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Outcome measures
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 Participants
KPL-404 2 mg/kg SC every 2 q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 Participants
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 Participants
Placebo SC q2wk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=27 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=25 Participants
Placebo SC q4wk for 12 weeks
|
Cohort 3 Placebo
n=26 Participants
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 Participants
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 Participants
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
7.4 percentage of participants
|
20.0 percentage of participants
|
3.8 percentage of participants
|
9.7 percentage of participants
|
25.0 percentage of participants
|
Adverse Events
Cohort 1 KPL-404 2 mg/kg q2wk
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 KPL-404 5 mg/kg q2wk
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1/2 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 KPL-404 5 mg/kg Qwk
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 3 KPL-404 5 mg/kg q2wk
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3 Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 4 KPL-404 400 mg q4wk
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4 Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 participants at risk
KPL-404 2 mg/kg SC q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 participants at risk
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 participants at risk
Placebo SC q2wk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg Qwk
n=27 participants at risk
KPL-404 5 mg/kg SC qwk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg q2wk
n=25 participants at risk
KPL-404 5 mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
|
Cohort 3 Placebo
n=26 participants at risk
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 participants at risk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 participants at risk
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
3.8%
1/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
Other adverse events
| Measure |
Cohort 1 KPL-404 2 mg/kg q2wk
n=6 participants at risk
KPL-404 2 mg/kg SC q2wk for 12 weeks
|
Cohort 2 KPL-404 5 mg/kg q2wk
n=6 participants at risk
KPL-404 5 mg/kg SC q2wk for 12 weeks
|
Cohort 1/2 Placebo
n=4 participants at risk
Placebo SC q2wk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg Qwk
n=27 participants at risk
KPL-404 5 mg/kg SC qwk for 12 weeks
|
Cohort 3 KPL-404 5 mg/kg q2wk
n=25 participants at risk
KPL-404 5 mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
|
Cohort 3 Placebo
n=26 participants at risk
Placebo SC qwk for 12 weeks
|
Cohort 4 KPL-404 400 mg q4wk
n=31 participants at risk
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8
|
Cohort 4 Placebo
n=20 participants at risk
Placebo SC q4wk for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
3.8%
1/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
7.4%
2/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
3.8%
1/26 • Up to 28 weeks
|
3.2%
1/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
7.7%
2/26 • Up to 28 weeks
|
3.2%
1/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Up to 28 weeks
|
16.7%
1/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
8.0%
2/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
3.2%
1/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
7.4%
2/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
3.2%
1/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Up to 28 weeks
|
16.7%
1/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
3.8%
1/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
4.0%
1/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
8.0%
2/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
6.5%
2/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to 28 weeks
|
16.7%
1/6 • Up to 28 weeks
|
50.0%
2/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
4.0%
1/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
6.5%
2/31 • Up to 28 weeks
|
10.0%
2/20 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
3.2%
1/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
3.7%
1/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
25.0%
1/4 • Up to 28 weeks
|
14.8%
4/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
7.7%
2/26 • Up to 28 weeks
|
6.5%
2/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to 28 weeks
|
16.7%
1/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
0.00%
0/25 • Up to 28 weeks
|
0.00%
0/26 • Up to 28 weeks
|
0.00%
0/31 • Up to 28 weeks
|
0.00%
0/20 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/6 • Up to 28 weeks
|
0.00%
0/4 • Up to 28 weeks
|
0.00%
0/27 • Up to 28 weeks
|
8.0%
2/25 • Up to 28 weeks
|
3.8%
1/26 • Up to 28 weeks
|
6.5%
2/31 • Up to 28 weeks
|
5.0%
1/20 • Up to 28 weeks
|
Additional Information
Clinical Operations Study Director
Kiniksa Pharmaceuticals, Ltd.
Phone: 1-781-431-9100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator shall not publish before a first multi-center publication by Sponsor. Before submission, Sponsor has 60 days to review any manuscript and 30 days to review any poster, abstract or any other materials. If Sponsor requests in writing, Investigator shall withhold disclosure for an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER