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Recruiting Phase 1, Phase 2 NCT06895499

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

Trial Parameters

Condition Hidradenitis Suppurativa
Sponsor Shanghai Huaota Biopharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-19
Completion 2026-01-30
Interventions
HB0043HB0043HB0043

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 1\. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with a disease duration of at least 6 months before screening; 4. Moderate to severe HS, concurrently meeting the following three criteria: 1. HS lesions in at least 2 distinct anatomic area; 2. One of the HS lesions must be Hurley Stage II or Hurley Stage III; 3. Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up. Exclusion Criteria: * 1\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus ery

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