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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

NCT05198310 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-07-22

Study results available
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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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

KPL-404

Humanized monoclonal antibody

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Kiniksa Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2024-02-08
Completion
2024-05-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • Hungary
  • Poland
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198310 on ClinicalTrials.gov