Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Running, not enrolling · Phase 1

Conditions studied: Hidradenitis Suppurativa

In brief

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

Key facts

Study ID: NCT06361836
Run by: Sonoma Biotherapeutics, Inc.
People needed: 24
Starts: 2024-10-09
Expected to finish: 2026-11-01
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 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

You may not qualify if…

Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
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

Where it is running

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

Full record on ClinicalTrials.gov

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