NCT07489573 Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
| NCT ID | NCT07489573 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Hidradenitis Suppurativa (HS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 36 participants in total. It began in 2026-06-01 with a primary completion date of 2029-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07489573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hidradenitis Suppurativa (HS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07489573 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07489573 currently recruiting?
Yes, NCT07489573 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07489573 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07489573 clinical trial?
NCT07489573 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 36 participants.