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

Phase 2RecruitingNCT06895499

Shanghai Huaota Biopharmaceutical Co., Ltd.15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

HB0043DRUG

Low dose

HB0043DRUG

Medium dose

HB0043DRUG

High dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Percentage of participants achieving HiSCR

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).

Time frame: Week 16 and 24

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

The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.

Time frame: Week 16 and 24

Change From Baseline in the number of lesions

The number of lesions refers to the total sum of abscesses, iInflammatory nodules, and draining fistulas count.

Time frame: Week 16 and 24

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

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.

Time frame: Week 16 and 24

Data from ClinicalTrials.gov

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