Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).

Eligibility criteria

Qualifiers

Signed informed consent must be obtained before any assessment is performed.

Chinese male and female participants ≥ 18 years of age.

Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline.

A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND

Disqualifiers

Total fistulae count ≥ 20 at baseline.

Any other active skin disease or condition that may interfere with assessment of HS at baseline.

Active inflammatory bowel disease.

Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious including tuberculosis and hepatitis, or gastrointestinal conditions), which in the opinion of the investigator, significantly immunocompromise the participant and/or place the participant at unacceptable risk for receiving an immunomodulatory therapy.

Trial design

Treatments tested in this trial

  • Secukinumab

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators