Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
NCT ID: NCT06361836
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-10-09
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SBT777101 Dose Level 1
Low dose SBT777101
SBT777101
Experimental treatment
SBT777101 Dose Level 2
Mid dose SBT777101
SBT777101
Experimental treatment
SBT777101 Dose Level 3
High dose SBT777101
SBT777101
Experimental treatment
Interventions
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SBT777101
Experimental treatment
Eligibility Criteria
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Inclusion Criteria
* 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 distinct anatomic 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-month course 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 drug administration
* Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration
Exclusion Criteria
* History of or current inflammatory or other autoimmune disease
* Complex presentations of HS
* Skin disease other than HS that may confound clinical assessments or increase subject 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
18 Years
70 Years
ALL
No
Sponsors
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Sonoma Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Arron, MD PhD
Role: STUDY_DIRECTOR
Sonoma Biotherapeutics, Inc.
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
SLUCare Academic Pavillion
St Louis, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBT777101-02
Identifier Type: -
Identifier Source: org_study_id
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