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