Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa
1 other identifier
interventional
41
1 country
15
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2021
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedStudy Start
First participant enrolled
August 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2023
CompletedAugust 29, 2023
August 1, 2023
2 years
June 23, 2021
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
From Day 0 until Day 56
Change in modified Sartorius Score (mSS) from Day 0 by time point
From Day 0 until Day 56
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
From Day 0 until Day 56
Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
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
- +3 more secondary outcomes
Study Arms (1)
Treatment group
EXPERIMENTALInterventions
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100144, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100730, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 51063, China
Union Hospital Tongji Medical College Huazong University of Science and Technology
Wuhan, Hubei, 100005, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
Chinese Academy of Medical Sciences and Peking Union Medical College
Nanjing, Jiangsu, 210042, China
The First Hospital of Jilin Universitv
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710004, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baoxi Wang, Master
Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
October 26, 2021
Study Start
August 18, 2021
Primary Completion
August 22, 2023
Study Completion
August 22, 2023
Last Updated
August 29, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share