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

Gilead Sciences

Status and phase: Enrolling; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: GS-0272; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06031415

GS-US-666-6692

Details and patient eligibility

About

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.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (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) ≥ 1.2 x upper limit of normal (ULN).
• Participant has 6 or more swollen and 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 2 bDMARD/tsDMARD therapeutics. A lack of efficacy 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 2 bDMARDs/tsDMARDs.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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87 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Drug: Placebo

Drug: GS-0272

Part B: Active RA Cohort: GS-0272 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GS-0272