Evaluating HB0043 for treating Hidradenitis Suppurativa

A Phase I/II, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).

This study is testing a new treatment called HB0043 to see if it helps adults with moderate to severe Hidradenitis Suppurativa feel better and stay safe during the process.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06895499 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of HB0043 in adult patients suffering from moderate to severe Hidradenitis Suppurativa (HS). The trial spans 28 weeks, including a screening phase of up to 4 weeks, a treatment period of 20 weeks, and a 4-week safety follow-up. Participants who discontinue treatment early are encouraged to remain in the study for safety monitoring. The study focuses on patients with specific criteria related to the severity and duration of their HS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of moderate to severe Hidradenitis Suppurativa lasting at least 6 months.

Not a fit: Patients with known hypersensitivity to HB0043 or those with other active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Hidradenitis Suppurativa for patients.

How similar studies have performed: While there have been studies on treatments for Hidradenitis Suppurativa, the specific approach with HB0043 is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Dermatology Hospital affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Conditions Hidradenitis Suppurativa