Phase
Condition
Acne Inversa
Hidradenitis Suppurativa
Scalp Disorders
Treatment
HB0043
Clinical Study ID
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 severeHS, 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.Presence of other active autoimmune diseases except HS, including but notlimited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupuserythematosus, inflammatory bowel disease, and uveitis; 4. Participant has anyother active skin disease or condition that may interfere with the assessmentof hidradenitis suppurativa; 5. History of lymphoproliferative disorders or anyknown malignancy within five years prior to the Screening Visit (excludingtreated and cured cutaneous squamous cell carcinoma, basal cell carcinoma,carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History ofrecurrent 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 ofthe investigator, the patient should not participate.
Study Design
Study Description
Connect with a study center
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong
ChinaActive - Recruiting
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