Study of GS-0272 in Participants With Rheumatoid Arthritis (MARASLE)

May 22, 2026 updated by: Gilead Sciences

A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis

The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA).

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0112
        • ARENSIA Exploratory Medicine LLC
  • Moldova
      • Chisinau, Moldova, MD-2025
        • IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
  • South Korea
      • Daejeon, South Korea, 35015
        • Chungnam National University Hospital
      • Seoul, South Korea, 110 744
        • Seoul National University Hospital
      • Suwon, South Korea, 16499
        • Ajou University Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire NHS Trust
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec Research Limited
      • Southampton, United Kingdom, SO16 6YD
        • NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
  • United States
    • California
      • Glendale, California, United States, 85306
        • Arizona Arthritis & Rheumatology Associates P.C.
      • Palo Alto, California, United States, 94304
        • Stanford School of Medicine, Division of Immunology & Rheumatology
      • Upland, California, United States, 91786
        • 1238 E. Arrow Hwy
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
    • Illinois
      • Niles, Illinois, United States, 60714
        • Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
      • Schaumburg, Illinois, United States, 60195
        • Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands LLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, United States, 19610
        • PA Regional Center for Arthritis and Osteoporosis Research
    • Texas
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research, Inc.
      • Irving, Texas, United States, 75061
        • Precision Comprehensive Clinical Research Solutions
      • Mesquite, Texas, United States, 75150
        • 1600 Republic Parkway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.

Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific 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.

Part B (Active RA Cohort)-Specific Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
  • Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Drug: Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Experimental: 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.
Drug: GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
Drug: Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame: First dose up to Week 12 plus 70 days
First dose up to Week 12 plus 70 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: First dose up to Week 12 plus 70 days
First dose up to Week 12 plus 70 days
Percentage of Participants With Laboratory Abnormalities
Time Frame: First dose up to Week 12 plus 70 days
First dose up to Week 12 plus 70 days
Pharmacokinetics (PK) of GS-0272: AUCtau
Time Frame: Day 1 predose through Day 197
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Day 1 predose through Day 197
PK of GS-0272: Cmax
Time Frame: Day 1 predose through Day 197
Cmax is defined the maximum observed plasma drug concentration.
Day 1 predose through Day 197
PK of GS-0272: Tmax
Time Frame: Day 1 predose through Day 197
Tmax is defined as the time to maximum observed concentration.
Day 1 predose through Day 197

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Antidrug Antibodies (ADAs) for GS-0272
Time Frame: Baseline (Day 1) through Day 197
Prevalence of ADAs will be measured as the proportion of participants who had at least one positive ADA sample (baseline or post-baseline) among all participants evaluable for ADA prevalence.
Baseline (Day 1) through Day 197
Incidence of ADAs for GS-0272
Time Frame: Baseline (Day 1) through Day 197
ADA incidence will be measured as the proportion of participants who have treatment-emergent ADA sample (post-baseline) among all participants evaluable for ADA incidence.
Baseline (Day 1) through Day 197
Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA
Time Frame: Baseline, Week 12
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Actual)

May 11, 2026

Study Completion (Actual)

May 11, 2026

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-666-6692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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