Study of GS-0272 in Participants With Rheumatoid Arthritis
NCT ID: NCT06031415
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
87 participants
INTERVENTIONAL
2023-09-28
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple doses of GS-0272, in participants with RA.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks.
Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.
GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Part B: Active RA Cohort: GS-0272 or Placebo
Part B will include participants with moderate-to-severe RA. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 2:1 ratio to receive either GS-0272 or placebo for 12 weeks.
GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
* Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with a stable dose for at least 4 weeks prior to the first dose of study drug, as follows:
* Individuals must not be on a biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug.
* Participant is seropositive as demonstrated by a positive anti-cyclic citrullinated peptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.
* Participant has an elevated high-sensitivity C-reactive protein (hsCRP) greater than upper limit of normal (ULN).
* Participant has 6 or more swollen and 6 or more tender joints as assessed on the SJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 joint eligibility.
* Participant has had inadequate response or intolerance to at least 1 but not more than 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.
Exclusion Criteria
* Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Arthritis & Rheumatology Associates P.C.
Glendale, California, United States
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California, United States
1238 E. Arrow Hwy
Upland, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Niles, Illinois, United States
Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, United States
Summit Headlands LLC
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Accurate Clinical Research, Inc.
Houston, Texas, United States
Precision Comprehensive Clinical Research Solutions
Irving, Texas, United States
1600 Republic Parkway
Mesquite, Texas, United States
ARENSIA Exploratory Medicine LLC
Tbilisi, , Georgia
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, , Moldova
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge, , United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, , United Kingdom
Kings College Hospital
London, , United Kingdom
Simbec Research Limited
Merthyr Tydfil, , United Kingdom
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-666-6692
Identifier Type: -
Identifier Source: org_study_id