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Clinical trial

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

ID
Name
STS-BDB001-06
Description
A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).
Trial arms
Trial start
2021-06-24
Estimated PCD
2023-07-07
Trial end
2023-07-07
Status
Completed
Phase
Early phase I
Treatment
BDB-001 Injection
Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Arms:
Treatment group 1, Treatment group 2
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Arms:
Treatment group 1, Treatment group 2
Placebo
Multiple IV infusions of Placebo Injection diluted in sodium chloride
Arms:
Placebo
Size
50
Primary endpoint
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Week 8
Number of Participants developing anti-BDB-001 antibodies.
Week 8
Area under the plasma concentration versus time curve (AUC) of BDB-001 Assessment of pharmacokinetic parameters.
Week 8
Peak Plasma Concentration (Cmax) of BDB-001and time to reach Cmax Assessment of pharmacokinetic parameters.
Week 8
Minimal Plasma Concentration (Cmin) of BDB-001 Assessment of pharmacokinetic parameters.
Week 8
Terminal phase half-life Assessment of pharmacokinetic parameters.
Week 8
Eligibility criteria
Inclusion Criteria: * 18 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. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-03-26

1 organization

2 products

1 indication

Product
BDB-001
Indication
Hidradenitis Suppurativa
Organization
Staidson Biopharmaceuticals
Product
Placebo