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

Rheumatoid Arthritis Clinical Trial

— MARASLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031415
• Other study ID #: GS-US-666-6692
• Status: Recruiting
• Phase: Phase 1
• Start date: September 28, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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) and systemic lupus erythematosus (SLE). The primary objectives of this study are to assess the safety and tolerability of multiple ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

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 (Systemic Lupus Erythematosus (SLE) Cohort)-Specific Inclusion Criteria:

• Fulfill EULAR/ACR 2019 classification criteria for SLE at least 24 weeks prior to the first dose of study drug.
• Individuals using protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents (antimalarials, methotrexate (MTX), azathioprine, cyclosporine, leflunomide, minocycline, mycophenolate mofetil, mycophenolic acid, dapsone, and oral [not topical] tacrolimus) for the treatment of SLE must maintain stable dose(s) for at least 4 weeks prior to the first dose of study drug and through the end of study.

Key Exclusion Criteria:

• Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
• Highly active SLE (including but not limited to lupus nephritis (with significant increases in urine protein/creatinine ratio over clinical baseline, recent worsening or creatinine clearance, and/or pyuria/hematuria), neuropsychiatric SLE, and/or vasculitis) that could put the individual at risk per investigator's judgment.
• Exposure to cyclophosphamide or any biologic lupus therapy within 8 weeks prior to the first dose of study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lupus Erythematosus, Systemic
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Intervention

Drug:
• GS-0272
Administered subcutaneously
• Placebo
Administered subcutaneously

Locations

Country	Name	City	State
Georgia	ARENSIA Exploratory Medicine LLC	Tbilisi
Moldova, Republic of	IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.	Chisinau
United Kingdom	Kings College Hospital	London
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Georgia,  Moldova, Republic of,  United Kingdom, 

Outcome

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

External Links

•   Gilead Clinical Trials Website