Phase
Condition
Cutaneous Lupus Erythematosus
Arthritis And Arthritic Pain
Musculoskeletal Diseases
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
GeorgiaSite Not Available
ARENSIA Exploratory Medicine LLC
Tbilisi 611717, 0112
GeorgiaActive - Recruiting
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 110 744
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, 16499
Korea, Republic ofSite Not Available
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau 618426, MD-2025
MoldovaActive - Recruiting
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon 1835235, 35015
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 110 744
South KoreaActive - Recruiting
Ajou University Hospital
Suwon 1835553, 16499
South KoreaActive - Recruiting
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
University Hospitals Coventry & Warwickshire NHS Trust
Coventry 2652221, CV2 2DX
United KingdomActive - Recruiting
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Kings College Hospital
London 2643743, SE5 9RS
United KingdomActive - Recruiting
Simbec Research Limited
Merthyr Tydfil, CF48 4DR
United KingdomSite Not Available
Simbec Research Limited
Merthyr Tydfil 2642705, CF48 4DR
United KingdomActive - Recruiting
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomSite Not Available
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton 2637487, SO16 6YD
United KingdomActive - Recruiting
Arizona Arthritis & Rheumatology Associates P.C.
Glendale, California 85306
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates PC
Glendale, California 85306
United StatesActive - Recruiting
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California 94304
United StatesSite Not Available
1238 E. Arrow Hwy
Upland, California 91786
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates P.C.
Glendale 5352423, California 5332921 85306
United StatesActive - Recruiting
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto 5380748, California 5332921 94304
United StatesActive - Recruiting
1238 E. Arrow Hwy
Upland 5404915, California 5332921 91786
United StatesActive - Recruiting
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Clinical Research of West Florida, Inc.
Clearwater 4151316, Florida 4155751 33765
United StatesActive - Recruiting
Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751 32216
United StatesActive - Recruiting
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Niles 4903730, Illinois 4896861 60714
United StatesActive - Recruiting
Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.
Schaumburg 4910713, Illinois 4896861 60195
United StatesActive - Recruiting
Summit Headlands LLC
Portland, Oregon 97210
United StatesSite Not Available
Summit Headlands LLC
Portland 5746545, Oregon 5744337 97210
United StatesActive - Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Altoona Center for Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635
United StatesCompleted
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing 5220248, Pennsylvania 6254927 19610
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas 76034
United StatesSite Not Available
Accurate Clinical Research, Inc.
Houston, Texas 77089
United StatesSite Not Available
1600 Republic Parkway
Mesquite, Texas 75150
United StatesSite Not Available
Precision Comprehensive Clinical Research Solutions
Colleyville 4682478, Texas 4736286 76034
United StatesActive - Recruiting
Accurate Clinical Research, Inc.
Houston 4699066, Texas 4736286 77089
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions
Irving 4700168, Texas 4736286 75061
United StatesActive - Recruiting
1600 Republic Parkway
Mesquite 4710826, Texas 4736286 75150
United StatesActive - Recruiting

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