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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT05198310

Public ClinicalTrials.gov record NCT05198310. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 6:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05198310
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Kiniksa Pharmaceuticals, Ltd.
Industry
Enrollment
145 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 14, 2021 (Actual)
Primary completion
Feb 8, 2024 (Actual)
Completion
May 6, 2024 (Actual)
Last update posted
Jul 22, 2025

2021 – 2024

United States locations

U.S. sites
19
U.S. states
7
U.S. cities
18
Facility City State ZIP Site status
Carewell Arthritis Center Apple Valley California 92307 —
Medvin Clinical Research Covina California 91722 —
Inland Rheumatology Clinical Trials Upland California 91786 —
Medvin Clinical Research Whittier California 90602 —
International Medical Research Daytona Beach Florida 32117 —
Sweet Hope Research Specialty, Inc. Hialeah Florida 33016 —
San Marcus Research Clinic, Inc. Miami Lakes Florida 33014 —
Millennium Research Ormond Beach Florida 32174 —
West Broward Rheumatology Associates, Inc. Tamarac Florida 33321 —
Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio 44130 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
Saint Francis Hospital- Memphis Memphis Tennessee 38119 —
Arthritis and Rheumatology Research Institute Allen Texas 75013 —
Trinity Universal Research Assoc Carrollton Texas 75007 —
Arthritis & Osteoporosis Center of Coastal Bend Corpus Christi Texas 78404 —
Southwest Rheumatology Research LLC Mesquite Texas 75150 —
DM Clinical Research Tomball Texas 77375 —
Rheumatology Clinic of Houston Tomball Texas 77377 —
Rheumatology and Pulmonary Clinic Beckley West Virginia 25801 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05198310, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2025 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05198310 live on ClinicalTrials.gov.

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