Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

Study Overview
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Brief Summary
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The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).

Official Title
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A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: BDB-001 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment) Exclusion Criteria: Never participated in the clinical study of STS-BDB001-06； Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: BDB-001 Injection<br>* Multiple IV infusions of BDB-001 Injection diluted in sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point | The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point | The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count*2) + (Draining Tunnel Count *4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11. | From Day 0 until Day 56 | 
| Change in modified Sartorius Score (mSS) from Day 0 by time point | The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome. | From Day 0 until Day 56 | 
| Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point | The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas. | From Day 0 until Day 56 | 
| Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point | Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA)classifies patients' severity into six categories:clear, minimal, mild, moderate, severe, and very severe, based on the number and quality of inflammatory lesions. | From Day 0 until Day 56 | 
| Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point. |  | From Day 0 until Day 56 | 
| Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point | A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome. | From Day 0 until Day 56 | 
| 7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point. |  | From Day 0 until Day 56] | 
| Safety of BDB-001 injection in the treatment of patients with HS will be assessed | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | From Day 0 until Day 77 |