Study of GS-0272 in Participants With Rheumatoid Arthritis

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 Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis

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: June 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• 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 (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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• GS-0272
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
• Placebo
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)

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
Secondary	Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA	Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.	Baseline, Week 12

External Links

•   Gilead Clinical Trials Website