Last updated: January 4, 2026
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Hidradenitis Suppurativa
Acne Inversa
Rosacea
Treatment
HB0043
Clinical Study ID
NCT06895499
HB0043-HS-0-01
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Understand the research procedure of this study and provide written informedconsent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with adisease 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;
Acceptance by the patient, of childbearing age, to use safe contraceptivemethods throughout the study, including six months of follow-up.
Exclusion
Exclusion Criteria:
- 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. Presenceof other active autoimmune diseases except HS, including but not limited topsoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus,inflammatory bowel disease, and uveitis; 4. Participant has any other active skindisease or condition that may interfere with the assessment of hidradenitissuppurativa; 5. History of lymphoproliferative disorders or any known malignancywithin five years prior to the Screening Visit (excluding treated and curedcutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ,or intraductal breast cancer in situ); 6. History of recurrent or recent seriousinfection; 7. Participant has active tuberculosis (TB) or concurrent treatment forlatent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or humanimmunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Anyreason why, in the opinion of the investigator, the patient should not participate.
Study Design
Total Participants: 15
Treatment Group(s): 1
Primary Treatment: HB0043
Phase: 1/2
Study Start date:
March 19, 2025
Estimated Completion Date:
March 30, 2026
Study Description
Connect with a study center
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong
ChinaSite Not Available
Dermatology Hospital affiliated to Shandong First Medical University
Jinan 1805753, Shandong 1796328
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.