Clinical Trials in the USA / NCT06361836
Active, not recruiting
Phase 1
Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
NCT06361836 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hidradenitis Suppurativa
Study summary
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.
Eligibility
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 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:
* 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
Primary outcome measure(s)
- Incidence, nature, and severity of adverse events [Safety and Tolerability] — Day of treatment to end of follow-up period (48 weeks)
- Incidence and nature of Dose Limiting Toxicities [DLTs] — Day of treatment to end of DLT evaluation period (28 days)
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | |
| University of Minnesota | Minneapolis | Minnesota | |
| SLUCare Academic Pavillion | St Louis | Missouri | |
| Columbia University Irving Medical Center | New York | New York | |
| Duke University | Durham | North Carolina | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas |
More Sonoma Biotherapeutics, Inc. trials in the USA
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06361836 on ClinicalTrials.gov ↗ ← All trials in the USA