Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— Regulate-HS  

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361836
• Other study ID #: SBT777101-02
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Sonoma Biotherapeutics, Inc.
• Contact: Sabrina Fox-Bosetti, MPH
• Phone: 415-992-6245
• Email: clinicaloperations[@]sonomabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Biological:
• SBT777101
Experimental treatment

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	SLUCare Academic Pavillion	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sonoma Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature, and severity of adverse events [Safety and Tolerability]		Day of treatment to end of follow-up period (48 weeks)
Primary	Incidence and nature of Dose Limiting Toxicities [DLTs]		Day of treatment to end of DLT evaluation period (28 days)