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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 Sep 8, 2026, 7:17 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 13, 2021
Primary completion
Feb 7, 2024
Completion
May 5, 2024
Last update posted
Jul 21, 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 21, 2025 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05198310 live on ClinicalTrials.gov.

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