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

RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Hidradenitis Suppurativa (HS)

Interventions: Secukinumab

Countries: China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (7)

Hangzhou, Zhejiang, China
Ningbo, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, China
Beijing, China
Shanghai, China
Tianjin, China