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

Staidson Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Drug: BDB-001 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05103423

STS-BDB001-06

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups, including a placebo group

Treatment group 1

Experimental group

Treatment:

Drug: Placebo

Drug: BDB-001 Injection

Drug: Placebo

Treatment group 2

Experimental group

Treatment:

Drug: Placebo

Drug: BDB-001 Injection

Drug: Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo