Clinical trial NCT05093855: Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
timeFrame: Week 8
Secondary outcomes:
measure: Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in modified Sartorius Score (mSS) from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.
timeFrame: From Day 0 until Day 56
measure: Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point
timeFrame: From Day 0 until Day 56
measure: 7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.
timeFrame: From Day 0 until Day 56]
measure: Safety of BDB-001 injection in the treatment of patients with HS will be assessed
timeFrame: From Day 0 until Day 77
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Chinese Academy of Medical Sciences and Peking Union Medical College
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin Universitv
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
name: Baoxi Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: