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Monoclonal Antibodies

GS-0272 for Rheumatoid Arthritis and Lupus (MARASLE Trial)

Phase 1
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose up to week 12 plus 70 days
Awards & highlights

MARASLE Trial Summary

This trial looks at the safety & tolerability of a drug (GS-0272) for RA & SLE patients, & how it affects their bodies.

Who is the study for?
This trial is for adults with Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE). RA patients must have been diagnosed at least 3 months ago and on stable csDMARDs, not b/tsDMARDs. SLE patients need a diagnosis from at least 24 weeks prior and stable nonbiologic treatments. Those with certain infections or highly active SLE are excluded.Check my eligibility
What is being tested?
The study tests GS-0272's safety and how the body processes it after multiple doses in RA and SLE patients. Participants will receive either GS-0272 or a placebo through subcutaneous injections to compare effects.See study design
What are the potential side effects?
While specific side effects of GS-0272 aren't listed, common ones for arthritis medications include injection site reactions, upper respiratory infections, headaches, nausea, and potential increases in liver enzymes.

MARASLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with RA more than 3 months ago, according to ACR/EULAR criteria.
Select...
I am not taking specific arthritis drugs and haven't for the last 4 weeks (or 16 weeks for rituximab).

MARASLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose up to week 12 plus 70 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to week 12 plus 70 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK of GS-0272: Cmax
PK of GS-0272: Tmax
Percentage of Participants Experiencing Adverse Events (AEs)
+3 more
Secondary outcome measures
Incidence of ADAs for GS-0272
Prevalence of Antidrug Antibodies (ADAs) for GS-0272

MARASLE Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or PlaceboExperimental Treatment2 Interventions
Part B will include participants with SLE. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 3:1 ratio to receive either GS-0272 or placebo for 12 weeks.
Group II: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or PlaceboExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,085 Previous Clinical Trials
848,283 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,493 Total Patients Enrolled
~26 spots leftby Jun 2025
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