Phase
Condition
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Cutaneous Lupus Erythematosus
Treatment
Placebo
GS-0272
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key 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 AmericanCollege of Rheumatology (ACR)/European League Against Rheumatism (EULAR)classification criteria.
Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumaticdrugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with astable 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 1or during the study and must discontinue b/tsDMARD use for at least 4 weeks (withthe exception of rituximab, which must be discontinued for at least 16 weeks) priorto the first dose of study drug.
Part B (Active RA Cohort)-Specific Inclusion Criteria:
Participant is seropositive as demonstrated by a positive anti-cyclic citrullinatedpeptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.
Participant has an elevated high-sensitivity C-reactive protein (hsCRP) greater thanupper limit of normal (ULN).
Participant has 6 or more swollen and 6 or more tender joints as assessed on theSJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 jointeligibility.
Participant has had inadequate response or intolerance to at least 1 but not morethan 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response isdefined as documented continued or recurrent disease activity after at least 12weeks of treatment of RA.
Exclusion
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 3 bDMARDs/tsDMARDs with more than 2MOAs.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112
GeorgiaActive - Recruiting
Seoul National University Hospital
Seoul, 110 744
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon, 16499
Korea, Republic ofActive - Recruiting
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, MD-2025
Moldova, Republic ofActive - Recruiting
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Kings College Hospital
London, SE5 9RS
United KingdomActive - Recruiting
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomActive - Recruiting
Arizona Arthritis & Rheumatology Associates PC
Glendale, California 85306
United StatesActive - Recruiting
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California 94304
United StatesActive - Recruiting
1238 E. Arrow Hwy
Upland, California 91786
United StatesActive - Recruiting
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
United StatesActive - Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesActive - Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Accurate Clinical Research, Inc.
Houston, Texas 77089
United StatesActive - Recruiting
1600 Republic Parkway
Mesquite, Texas 75150
United StatesActive - Recruiting
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