Completed PHASE2 INTERVENTIONAL 9-arm NCT05198310

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

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

Sponsor: Kiniksa Pharmaceuticals, Ltd.

Conditions Arthritis, Rheumatoid

Interventions KPL-404 Placebo

Updated 19 times since 2022 Last updated: Jul 2, 2025 Started: Dec 14, 2021 Primary completion: Feb 8, 2024 Completion: May 6, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Arthritis, Rheumatoid and is currently completed. Kiniksa Pharmaceuticals, Ltd. leads this study, which shows 19 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

19 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Aug 2025 — Sep 2025 [monthly]

Completed PHASE2
Mar 2025 — Aug 2025 [monthly]

Completed PHASE2
Sep 2024 — Mar 2025 [monthly]

Completed PHASE2
Aug 2024 — Sep 2024 [monthly]

Completed PHASE2

▶ Show 14 earlier versions

Jul 2024 — Aug 2024 [monthly]

Completed PHASE2

Status: Active Not Recruiting → Completed
Apr 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE2
Dec 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Oct 2023 — Dec 2023 [monthly]

Recruiting PHASE2
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE2
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE2
Jun 2023 — Aug 2023 [monthly]

Recruiting PHASE2
May 2023 — Jun 2023 [monthly]

Recruiting PHASE2
Mar 2023 — May 2023 [monthly]

Recruiting PHASE2
Feb 2023 — Mar 2023 [monthly]

Recruiting PHASE2
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE2
Dec 2022 — Jan 2023 [monthly]

Recruiting PHASE2
May 2022 — Dec 2022 [monthly]

Recruiting PHASE2
Feb 2022 — May 2022 [monthly]

Recruiting PHASE2

First recorded

Dec 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Kiniksa Pharmaceuticals, Ltd.

Data source: Kiniksa Pharmaceuticals International, plc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Allen, United States , Apple Valley, United States , Beckley, United States , Budapest, Hungary , Cape Town, South Africa , Carrollton, United States , Corpus Christi, United States , Covina, United States , Daytona Beach, United States , Duncansville, United States and 27 more locations