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

Last updated: April 3, 2025
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Acne Inversa

Hidradenitis Suppurativa

Scalp Disorders

Treatment

HB0043

Clinical Study ID

NCT06895499
HB0043-HS-0-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  1. 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:

  2. HS lesions in at least 2 distinct anatomic area;

  3. One of the HS lesions must be Hurley Stage II or Hurley Stage III;

  4. 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 contraceptivemethods throughout the study, including six months of follow-up.

Exclusion

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 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

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: HB0043
Phase: 1/2
Study Start date:
March 19, 2025
Estimated Completion Date:
March 30, 2026

Study 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 prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Connect with a study center

  • Dermatology Hospital affiliated to Shandong First Medical University

    Jinan, Shandong
    China

    Active - Recruiting

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