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

  • STATUS
    Recruiting
  • End date
    Jun 7, 2023
  • participants needed
    49
  • sponsor
    Staidson (Beijing) Biopharmaceuticals Co., Ltd
Updated on 7 June 2022
abscess

Summary

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

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

Eligibility

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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