Phase
Condition
Rosacea
Collagen Vascular Diseases
Connective Tissue Diseases
Treatment
SBT777101
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) ≤50 kg/m2, inclusive
Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3)
Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinctanatomic regions, with at least 1 accessible AN of adequate size for biopsy (diameter > 1 cm)
Total draining tunnel (dT) count of ≤20
Documented history of inadequate response or intolerance to at least a 3-monthcourse of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab)
Doses of medications for HS must be stable for at least 5 weeks prior to study drugadministration
Must agree to use highly effective method of contraception for at least 1 year postSBT777101 administration
Exclusion
Exclusion Criteria:
Major surgery within 12 weeks prior to screening or planned within 12 months afterdosing
History of or current inflammatory or other autoimmune disease
Complex presentations of HS
Skin disease other than HS that may confound clinical assessments or increasesubject risk in the study
Uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic,endocrine, or gastrointestinal disease
Active current infection or history of recurrent infections
Active or untreated latent tuberculosis
Primary or secondary immunodeficiency
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
SLUCare Academic Pavillion
Saint Louis, Missouri 63110
United StatesSite Not Available
SLUCare Academic Pavillion
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Duke University
Durham, North Carolina 27708
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27708
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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