Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

  • End date
    Jun 7, 2023
  • participants needed
  • sponsor
    Staidson (Beijing) Biopharmaceuticals Co., Ltd
Updated on 7 June 2022


A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).

Condition Hidradenitis Suppurativa
Treatment Placebo, BDB-001 Injection
Clinical Study IdentifierNCT05103423
SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd
Last Modified on7 June 2022


Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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