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

NCT06895499 | Recruiting Phase 1

• 1 other identifier: HB0043-HS-0-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS

  The incidence rate, characteristics, relevance, and severity of treatment-emergent adverse events (TEAEs) experienced by subjects during the treatment period.

  From randomization to end of study, assessed up to 24 weeks.

Secondary Outcomes (17)

• Percentage of participants achieving HiSCR

  Week 16 and 24

• Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count

  Week 16 and 24

• Change From Baseline in the number of lesions

  Week 16 and 24

• Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS

  Week 16 and 24

• Percentage of participants achieving HiSCR75

  Week 16 and 24

Study Arms (3)

HB0043: Low dose

EXPERIMENTAL

Participants assigned to arm 1 will receive a low dose of HB0043 via intravenous infusion every two weeks starting from week 0. The dose of HB0043 will adjusted to high dose at weeks 10, and the frequency remains Q2W. The frequency will adjusted to Q4W from weeks16, the last administration is weeks 20.

Drug: HB0043

HB0043: Medium dose

EXPERIMENTAL

Participants assigned 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.

Drug: HB0043

HB0043: High dose

EXPERIMENTAL

Participants assigned to Arm 3 will receive a high dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.

Drug: HB0043

Interventions

HB0043 DRUG

Low dose

HB0043: Low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Huaota Biopharmaceutical Co., Ltd.: lead
• Dermatology Hospital affiliated to Shandong First Medical University: collaborator

Study Sites (1)

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 26, 2025
• Study Start: March 19, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)