Secukinumab in Chinese adults with moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4 interventional study evaluating the safety and efficacy of secukinumab (AIN457) in Chinese adults with HS. Participants start with an induction phase followed by longer-term dosing every 4 weeks or switching to every 2 weeks, with a total study duration up to 66 weeks including a post-treatment follow-up. The study includes screening, two sequential treatment periods, and a post-treatment observation period to monitor outcomes and safety. Eligibility requires confirmed HS for at least 6 months, specific lesion and body-area criteria, and informed consent. Exclusion criteria include high fistula burden and other active conditions that could confound assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Guangzhou, Guangdong, China Recruiting
• Novartis Investigative Site
  Shijiazhuang, Hebei, China Recruiting
• Novartis Investigative Site
  Chengdu, Sichuan, China Recruiting
• Novartis Investigative Site
  Hangzhou, Zhejiang, China Recruiting
• Novartis Investigative Site
  Ningbo, Zhejiang, China Recruiting
• Novartis Investigative Site
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: + 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Soquelitinib in adults with hidradenitis suppurativa

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• SPY072 in adults with moderate to severe hidradenitis suppurativa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.