Clinical trial NCT06895499: Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dermatology Hospital affiliated to Shandong First Medical University
First posted: 2025-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS
timeFrame: From randomization to end of study, assessed up to 24 weeks.
Secondary outcomes:
measure: Percentage of participants achieving HiSCR
timeFrame: Week 16 and 24
measure: Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
timeFrame: Week 16 and 24
measure: Change From Baseline in the number of lesions
timeFrame: Week 16 and 24
measure: Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS
timeFrame: Week 16 and 24
measure: Percentage of participants achieving HiSCR75
timeFrame: Week 16 and 24
measure: Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
timeFrame: Week 16 and 24
measure: Serum HB0043 concentrations throughout the study
timeFrame: From randomization to end of study, assessed up to 24 weeks.
measure: Incidence of anti-HB0043 antibody positive response throughout the study
timeFrame: From randomization to end of study, assessed up to 24 weeks.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Dermatology Hospital affiliated to Shandong First Medical University
state: Shandong
Study officials:
References: