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

NCT07489573 | Not Yet Recruiting Phase 4

• 1 other identifier: CAIN457M2401
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Moderate to severe hidradenitis suppurativa (HS); IL-17A; monoclonal antibody; AIN457; secukinumab; HiSCR; pain; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving HiSCR50 at 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.

  Week 16

Secondary Outcomes (8)

• Percentage change from baseline in AN Count at Week 16

  Week 16

• Percentage of participants experiencing an HS Flare through Week 16

  Up to Week 16

• Percentage of participants achieving NRS30 Skin Pain Response at Week 16

  Week 16

• Percentage of participants achieving HiSCR50 through Week 52

  Up to Week 52

• Percentage of participants experiencing HS Flares through Week 52

  Up to Week 52

Study Arms (2)

Secukinumab Q2W

EXPERIMENTAL

Participants receive secukinumab administered every two weeks (Q2W) at the specified dose

Drug: Secukinumab

Secukinumab Q4W

EXPERIMENTAL

Participants receive secukinumab administered every four weeks (Q4W) at the specified dose

Drug: Secukinumab

Interventions

Secukinumab DRUG

secukinumab 300 mg s.c. administered Q2W or Q4W

Secukinumab Q2W; Secukinumab Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa; Pain

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start (Estimated): August 21, 2026
• Primary Completion (Estimated): September 25, 2029
• Study Completion (Estimated): November 5, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share