NCT06895499

Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

A Phase I/II, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

Detailed description

The total duration of the study is 28 weeks and consists of: Screening (up to 4 weeks), Treatment Period (20 weeks) and Safety Follow-Up (treatment-free follow-up for 4 weeks). Participants who prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	HB0043	Low dose
DRUG	HB0043	Medium dose
DRUG	HB0043	High dose

Timeline

• Start date: 2025-03-19
• Primary completion: 2026-01-30
• Completion: 2026-03-30
• First posted: 2025-03-26
• Last updated: 2026-01-07

Locations

1 site across 1 country: China