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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose up to week 12 plus 70 days

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,431 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,645 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has GS-0272 been formally sanctioned by the Federal Drug Administration?

"There is limited clinical evidence for the safety and efficacy of GS-0272, so it gets a score of 1."

Answered by AI

Is this research initiative open to adults of a certain age and older?

"Those eager to join this clinical trial must fall between the ages of 18 and 75. Meanwhile, there are 78 studies for minors under 18 years old and 463 trials designed specifically for seniors over 65."

Answered by AI

Is there an ongoing recruitment for participants in this research trial?

"As per clinicaltrials.gov, this medical trial is actively seeking participants - it was first made available on September 28th 2023 and last modified on October 9th of the same year."

Answered by AI

How many participants are enrolled in the current clinical trial?

"Affirmative. According to the data available on clinicaltrials.gov, this medical trial has been open since September 28th 2023 and is still seeking volunteers for participation. The research team requires 48 participants from a single site."

Answered by AI

Is it possible for me to join this medical research?

"This clinical trial is recruiting 48 participants aged 18-75 who have rheumatoid arthritis. The selection criteria includes adhering to the 2010 American College of Rheumatology/European League Against Rheumatism classification; not being on a biologic or synthetic disease-modifying antirheumatic drug at start date and for 4 weeks (except for rituximab which requires 16 week discontinuation); fulfilling EULAR/ACR 2019 SLE classifications at least 24 weeks prior, and maintaining stable doses of protocol-approved immunosuppressive agents (antimalarials, methotrexate, etc"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus

2023. "Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06031415.

All > Systemic Lupus Erythematosus > Ra