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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Peking University First Hospital
Beijing, Beijing Municipality, China
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
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.
Time frame: Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 until Day 56
Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Chinese Academy of Medical Sciences and Peking Union Medical College
Nanjing, Jiangsu, China
The First Hospital of Jilin Universitv
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
...and 5 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 until Day 56
7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.
Time frame: 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.
Time frame: From Day 0 until Day 77