CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
KPL-404 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05198310
NCT05198310Phase 2Completed

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor

Kiniksa Pharmaceuticals, Ltd.·interventional·Posted Jan 20, 2022·Updated Jul 22, 2025

In Brief

A Phase 2 clinical trial evaluating KPL-404 and Placebo for Arthritis, Rheumatoid. Completed, enrolled 145 participants across 42 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Czechia, Georgia, Hungary, Poland, South Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 20, 2022
Enrollment StartDec 14, 2021
Primary CompletionFeb 8, 2024
Study CompletionMay 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.5 years ago

Interventions

KPL-404drug

Humanized monoclonal antibody

Placebodrug

Matching placebo