Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT ID: NCT05103423
Last Updated: 2024-03-26
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2021-06-24
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group 1
BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Treatment group 2
BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Placebo
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Interventions
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BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Staidson (Beijing) Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Baoxi Wang, Master
Role: PRINCIPAL_INVESTIGATOR
Plastic Surgery Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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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
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 First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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STS-BDB001-06
Identifier Type: -
Identifier Source: org_study_id
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