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Clinical Trials in China / NCT06895499
Recruiting Phase 1/2

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

NCT06895499 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Phase
Phase 1/2
Started
2025-03-19
Last updated
2026-01-07

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

HB0043HB0043HB0043

HB0043: Low dose

HB0043: Medium dose

HB0043: High dose

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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 erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History of recurrent or recent serious infection; 7. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dermatology Hospital affiliated to Shandong First Medical University Jinan Shandong Recruiting

More Shanghai Huaota Biopharmaceutical Co., Ltd. trials in China

Other trials for the same condition

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 NCT06895499 on ClinicalTrials.gov ↗ ← All trials in China