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
Summary
Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
Timeline
- Start
- 2021-12-14
- Primary completion
- 2024-02-08
- Completion
- 2024-05-06
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Cohort 3 KPL-404 5 mg/kg Qwk vs Cohort 3 Placebo; p = 0.0470; LS Mean Difference -0.57 (95% CI -1.13 to -0.01) reads as mixed primary results NCT05198310 ↗
registry analysis (superiority test); Cohort 3 KPL-404 5 mg/kg q2wk vs Cohort 3 Placebo; p = 0.2124; LS Mean Difference -0.36 (95% CI -0.92 to 0.21) reads as mixed primary results NCT05198310 ↗
registry analysis (superiority test); Cohort 4 KPL-404 400 mg q4wk vs Cohort 4 Placebo; p = 0.1091; LS Mean Difference -0.58 (95% CI -1.28 to 0.13) reads as mixed primary results NCT05198310 ↗
release “Phase 2 clinical trial of abiprubart in rheumatoid arthritis met its primary efficacy endpoint” reads as met primary endpoint kiniksa.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiprubart | Monoclonal antibody | 2 mg/kg | Subcutaneous |
| Subject | Abiprubart | Monoclonal antibody | 5 mg/kg | Subcutaneous |
| Subject | Abiprubart | Monoclonal antibody | 400 mg | Subcutaneous |