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

Study Overview
=================
Brief Summary
-----------------
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled, Phase I/II Study to Explore Safety and Efficacy of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: BDB-001 Injection
* Drug: Placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old≤Age≤65 years old, male or female; Diagnosis of HS for at least 6 months; HS lesions must be present in at least two distinct anatomical areas, one of which must be at least located in the apocrine sweat gland area and Hurley Stage II or Hurley Stage III; Total abscess and inflammatory nodule (AN) count of ≥ 3. Exclusion Criteria: Subject was previously treated with adalimumab or another biologic product during the 3 months before the first administration; Subject received any oral antibiotic treatment for HS within 2 weeks before the first administration; Subject received any oral retinoids treatment for HS within 4 weeks before the first administration; Subject received oral opioids analgesics within 1 week before the first administration; Systematic treatment with glucocorticoid or intramural injection within 4 weeks before the first administration; History of heart disease or malignancy.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group 1<br> | Drug: BDB-001 Injection<br>* Multiple IV infusions of BDB-001 Injection diluted in sodium chloride<br>Drug: Placebo<br>* Multiple IV infusions of Placebo Injection diluted in sodium chloride<br>|
| Experimental: Treatment group 2<br> | Drug: BDB-001 Injection<br>* Multiple IV infusions of BDB-001 Injection diluted in sodium chloride<br>Drug: Placebo<br>* Multiple IV infusions of Placebo Injection diluted in sodium chloride<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Multiple IV infusions of Placebo Injection diluted in sodium chloride<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients. | Week 8 | 
| Number of Participants developing anti-BDB-001 antibodies. | Safety and tolerability of BDB-001 injection after multiple administration in the treatment of HS patients. | Week 8 | 
| Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters. | To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients. | Week 8 | 
| Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters. | To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients. | Week 8 | 
| Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters. | To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients. | Week 8 | 
| Terminal phase half-life Assessment of pharmacokinetic parameters. | To evaluate the pharmacokinetic characteristics of BDB-001 injection after multiple administration in HS patients. | 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 | 
| Changes in Pain VAS score from Day 0 by time point | Pain VAS:This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the VAS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. | From Day 0 until Day 56 |