Status:
RECRUITING
Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.
Lead Sponsor:
Shanghai Huaota Biopharmaceutical Co., Ltd.
Collaborating Sponsors:
Dermatology Hospital affiliated to Shandong First Medical University
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 prema...
Eligibility Criteria
Inclusion
- 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:
- HS lesions in at least 2 distinct anatomic area;
- One of the HS lesions must be Hurley Stage II or Hurley Stage III;
- 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
- 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.
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06895499
Start Date
March 19 2025
End Date
March 30 2026
Last Update
January 7 2026
Active Locations (1)
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1
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China