Phase
Condition
Sjogren's Syndrome
Dermatomyositis (Connective Tissue Disease)
Treatment
Placebo
RSLV-132
Clinical Study ID
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Providing written informed consent
Weight at least 45 kg
Meet the 2016 American College of Rheumatology (ACR)/European League AgainstRheumatism (EULAR) Classification Criteria for pSS
Diagnosis in the last 10 years
Positive anti-Ro/SSA antibody test
Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)scale and the ESSPRI fatigue scale
Of non childbearing potential or of childbearing potential and using highlyeffective contraceptive measures
Exclusion
Exclusion Criteria:
Diagnosis of any active autoimmune disease other than pSS that could affect theefficacy assessments
Uncontrolled hypothyroidism or severe fibromyalgia
New medications or change in medications in the last 4 weeks for pSS symptoms
Receipt of other prohibited medications
Apheresis or blood donation
Allergic reaction to RSLV-132 or biologic therapy
Clinically significant infection in last 30 days
Participation in another clinical study
Malignancy in last 5 years
Positive test for HIV or hepatitis
Major surgery in last 30 days or anticipated surgery during the study
Pregnancy or breast feeding
Laboratory blood tests outside of specified ranges
Other medical conditions or medications that would make the participant unsuitable
Study Design
Connect with a study center
Resolve Clinical Site
Chula Vista, California 91910
United StatesActive - Recruiting
Resolve Clinical Site
Napa, California 94558
United StatesActive - Recruiting
Advanced Clinical Research Center
San Diego, California 92108
United StatesSite Not Available
Resolve Clinical Site
Santa Clarita, California 91350
United StatesSite Not Available
Resolve Clinical Site
Boca Raton, Florida 34994
United StatesActive - Recruiting
Resolve Clinical Site
Boynton Beach, Florida 33467
United StatesActive - Recruiting
Evolution Research Center
Hialeah, Florida 33024
United StatesActive - Recruiting
GNP Research
Hollywood, Florida 33024
United StatesActive - Recruiting
Resolve Clinical Site
Miami, Florida 33140
United StatesActive - Recruiting
Life Medical Research
Miami Gardens, Florida 33014
United StatesActive - Recruiting
Sarasota Arthritis Research Center
Sarasota, Florida 34239
United StatesSite Not Available
Resolve Clinical Site
Chicago, Illinois 60607
United StatesActive - Recruiting
Tufts College
Boston, Massachusetts 02111-1817
United StatesActive - Recruiting
Resolve Clinical Site
Albuquerque, New Mexico 87106
United StatesActive - Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina 28208
United StatesActive - Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Onsite Clinical Solutions
Salisbury, North Carolina 28277
United StatesActive - Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
M3 Wake Research
Chatanooga, Tennessee 27615
United StatesSite Not Available
Accurate Clinical Research
Houston, Texas 77089
United StatesSite Not Available
Resolve Clinical Site
Katy, Texas 77449
United StatesActive - Recruiting
Resolve Clinical Site
McKinney, Texas 75069
United StatesActive - Recruiting
Accurate Clinical Research
Richmond, Texas 77089
United StatesActive - Recruiting
Resolve Clinical Site
San Antonio, Texas 78215
United StatesActive - Recruiting
Metrodora Institute
Salt Lake City, Utah 84119
United StatesActive - Recruiting
Arthritis Northwest
Spokane, Washington 99204
United StatesActive - Recruiting
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