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

Primary Purpose

Rheumatoid Arthritis, Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-0272
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Altoona Center for Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo

Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Adverse Events (AEs)
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Percentage of Participants With Laboratory Abnormalities
Pharmacokinetics (PK) of GS-0272: AUCtau
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
PK of GS-0272: Cmax
Cmax is defined the maximum observed plasma drug concentration.
PK of GS-0272: Tmax
Tmax is defined as the time to maximum observed concentration.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 4, 2023
Last Updated
October 9, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06031415
Brief Title
Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part A will have sequential cohorts. Part A and Part B will be in parallel.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GS-0272
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered subcutaneously
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame
First dose up to Week 12 plus 70 days
Title
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame
First dose up to Week 12 plus 70 days
Title
Percentage of Participants With Laboratory Abnormalities
Time Frame
First dose up to Week 12 plus 70 days
Title
Pharmacokinetics (PK) of GS-0272: AUCtau
Description
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Time Frame
Day 1 predose through Day 197
Title
PK of GS-0272: Cmax
Description
Cmax is defined the maximum observed plasma drug concentration.
Time Frame
Day 1 predose through Day 197
Title
PK of GS-0272: Tmax
Description
Tmax is defined as the time to maximum observed concentration.
Time Frame
Day 1 predose through Day 197
Secondary Outcome Measure Information:
Title
Prevalence of Antidrug Antibodies (ADAs) for GS-0272
Description
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.
Time Frame
Baseline (Day 1) through Day 197
Title
Incidence of ADAs for GS-0272
Description
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.
Time Frame
Baseline (Day 1) through Day 197

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study?nctid=NCT06031415
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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