Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
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
1 other identifier
interventional
50
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2021
Typical duration for phase_1
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
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2023
CompletedMarch 26, 2024
June 1, 2023
2 years
June 23, 2021
March 25, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
Treatment group 1
EXPERIMENTALTreatment group 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
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 First 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 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
November 2, 2021
Study Start
June 24, 2021
Primary Completion
July 7, 2023
Study Completion
July 7, 2023
Last Updated
March 26, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share