Secukinumab: secukinumab 300 mg s.c. administered Q2W or Q4W
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Participants with moderate to severe HS at baseline defined as:
* A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND
* Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
Exclusion Criteria:
* 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.
* Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any interventional trial
* Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A, IL-17 A/F or the IL-17 receptor.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study.
Primary outcome measure(s)
Percentage of participants achieving HiSCR50 at Week 16 — Week 16 HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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