OVERVIEW
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 (MARASLE)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Rheumatoid Arthritis
Gender
N/A
Date
September 2023 - May 2026
Study Type
Interventional
Study Phase
Phase 1
Product
GS-0272, Placebo
Eligibility information
Inclusion criteria
- Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.
- 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) greater than upper limit of normal (ULN).
- Participant has 6 or more swollen and 6 or more 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 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.
Exclusion criteria
- Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
- Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (24)
Arizona Arthritis & Rheumatology Associates P.C.
Glendale, California, United States, 85306
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California, United States, 94304
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Niles, Illinois, United States, 60714
Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, United States, 60195
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, United States, 19610
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States, 76034
Accurate Clinical Research, Inc.
Houston, Texas, United States, 77089
Precision Comprehensive Clinical Research Solutions
Irving, Texas, United States, 75061
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, Moldova, MD-2025
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial