Testing a new treatment for hidradenitis suppurativa
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
This study is testing a new treatment using the patient's own immune cells to see if it can help reduce inflammation in people with hidradenitis suppurativa.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sonoma Biotherapeutics, Inc. Industry-sponsored |
| Drugs / interventions | adalimumab, secukinumab |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT06361836 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effects of SBT777101, a novel regulatory T cell therapy, administered as a single dose to patients with hidradenitis suppurativa. The therapy utilizes the patient's own Treg cells to target and reduce inflammation in affected tissues. The study will begin with lower doses to assess safety before increasing to higher doses. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate-to-severe hidradenitis suppurativa who have not responded adequately to previous treatments.
Not a fit: Patients with complex presentations of hidradenitis suppurativa or those with other inflammatory autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce inflammation and improve the quality of life for patients with hidradenitis suppurativa.
How similar studies have performed: While this approach is novel, similar therapies targeting regulatory T cells have shown promise in other autoimmune conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 5 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- SLUCare Academic Pavillion — Saint Louis, Missouri, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Sabrina Fox-Bosetti, MPH
- Email: clinicaloperations@sonomabio.com
- Phone: 415-992-6245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.