Ireland
--:--IST
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
Phase
Phase 1
Started
2024-10-09
Last updated
2026-02-20

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

SBT777101 →

SBT777101: Experimental treatment

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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