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NCT05198310 · ClinicalTrials.gov registry record · Phase 2
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 study, sponsored by Kiniksa Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT05198310: Completed Phase 2 study, sponsored by Kiniksa Pharmaceuticals.
NCT05198310 is a Phase 2 study that has completed, run by Kiniksa Pharmaceuticals. The registered enrollment target is 145 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05198310, a Phase 2 study, has completed, sponsored by Kiniksa Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study 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.
Primary Outcome
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 p
Interventions
- DRUG Placebo
- DRUG KPL-404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2024-05-06 |
| Phase | Phase 2 |
What the finished NCT05198310 record still lists
NCT05198310 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05198310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05198310 about?
NCT05198310 is a clinical study titled "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". Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
What is the current status of trial NCT05198310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2021-12-14. Estimated completion is 2024-05-06.
What interventions are being tested in trial NCT05198310?
The interventions under investigation include: Placebo (DRUG), KPL-404 (DRUG).
Who is sponsoring clinical trial NCT05198310?
This trial is sponsored by Kiniksa Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05198310's enrollment target sits among peer trials
145 498th of 2000 higher than 1,501 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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