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

Staidson Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: BDB-001 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05093855

STS-BDB001-08

Details and patient eligibility

About

The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment)

Exclusion criteria

• Never participated in the clinical study of STS-BDB001-06；
• Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Treatment group

Experimental group

Treatment:

Drug: BDB-001 Injection