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Recruiting Phase 4

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

NCT07489573 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-06-01
Last updated
2026-09-09

Condition(s) studied

Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

Secukinumab →

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.

Trial sites (10)

FacilityCityRegionStatus
Novartis Investigative Site Guangzhou Guangdong Recruiting
Novartis Investigative Site Shijiazhuang Hebei Recruiting
Novartis Investigative Site Chengdu Sichuan Recruiting
Novartis Investigative Site Hangzhou Zhejiang Recruiting
Novartis Investigative Site Ningbo Zhejiang Recruiting
Novartis Investigative Site Wenzhou Zhejiang Recruiting
Novartis Investigative Site Beijing China Recruiting
Novartis Investigative Site Beijing China Recruiting
Novartis Investigative Site Shanghai China Recruiting
Novartis Investigative Site Tianjin China Recruiting
Official registry record

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.

View NCT07489573 on ClinicalTrials.gov ↗ ← All trials in China