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

Phase 1

Recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: HB0043

• Registration Number: NCT06895499
• Lead Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study Start: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-01-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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:

  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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HB0043: Low dose	HB0043	Participants randomized to Arm 1 will receive a low dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.
HB0043: Medium dose	HB0043	Participants randomized to Arm 2 will receive a medium dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.
HB0043: High dose	HB0043	Participants randomized to Arm 2 will receive a high dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS	From randomization to end of study, assessed up to 24 weeks.	The incidence rate, characteristics, relevance, and severity of treatment-emergent adverse events (TEAEs) experienced by subjects during the treatment period.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants achieving HiSCR	Week 16 and 24	Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (\>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count	Week 16 and 24	The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Change From Baseline in the number of lesions	Week 16 and 24	The number of lesions refers to the total sum of abscesses, iInflammatory nodules, and draining fistulas count.
Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)	Week 16 and 24	Change from baseline in IHS4. IHS4 score is calculated by the number of nodules (multiplied by 1) + the number of abscesses (multiplied by 2) + the number of draining tunnels (multiplied by 4).; A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.
Serum HB0043 concentrations throughout the study	From randomization to end of study, assessed up to 24 weeks.
Incidence of anti-HB0043 antibody positive response throughout the study	From randomization to end of study, assessed up to 24 weeks.
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS	Week 16 and 24	PGA-NRS is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the PGA-NRS.
Percentage of participants achieving HiSCR75	Week 16 and 24	HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count

Trial Locations

Locations (1)

Dermatology Hospital affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China