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

An Open-label, Multicenter Study Assessing Efficacy and Safety of Secukinumab up to One Year in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

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).

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: Secukinumab

Detailed Description

The study consists of a Screening period (at least 7 days and up to 4 weeks), Treatment Period 1 (16 weeks), Treatment Period 2 (36 weeks), and a post-treatment Follow-up period (10 or 12 weeks depending on dose regimens). Total duration of the study is up to 66 weeks.

Screening period: A screening period of at least 7 days and up to 4 weeks will be used to assess the participant´s eligibility, to complete 7-day Pain NRS and to washout and/or taper prohibited medication(s).

Treatment Period 1: All participants will be administered subcutaneous (s.c.) injections of secukinumab 300 mg once a week for five weeks (induction) at Baseline, Weeks 1, 2, 3 and 4. Thereafter, the frequency of study drug injections will be every 4 weeks for all participants up to Week 16.

Treatment Period 2: Starting from Week 16, participants can continue secukinumab 300 mg Q4W dosing until Week 48 or switch to secukinumab 300 mg Q2W, until Week 50 based on investigator's judgement at Week 16.

Follow-up period: Participants who prematurely discontinue study treatment in Treatment Periods 1 or 2 for any reason will enter the Post-Treatment Follow-Up period and complete the EOS visit (12 weeks after the last administration of study treatment).

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab Q2W; Participants receive secukinumab administered every two weeks (Q2W) at the specified dose	Drug: Secukinumab; secukinumab 300 mg s.c. administered Q2W or Q4W
Experimental: Secukinumab Q4W; Participants receive secukinumab administered every four weeks (Q4W) at the specified dose	Drug: Secukinumab; secukinumab 300 mg s.c. administered Q2W or Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in AN Count at Week 16	Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count.	Week 16
Percentage of participants experiencing an HS Flare through Week 16	Flare is defined as at least a 25% increase in AN count from baseline with a minimum absolute increase of 2 lesions.	Up to Week 16
Percentage of participants achieving NRS30 Skin Pain Response at Week 16	Among participants with baseline NRS ≥3, NRS30 is defined as ≥30% reduction and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst level).	Week 16
Percentage of participants achieving HiSCR50 through Week 52	Proportion of participants achieving HiSCR50 (≥50% reduction in AN count with no worsening of abscesses or draining fistulae) with secukinumab 300 mg Q2W or Q4W.	Up to Week 52
Percentage of participants experiencing HS Flares through Week 52	Flare defined as ≥25% increase from baseline in AN count with a minimum increase of 2 lesions.	Up to Week 52
Percentage of participants achieving NRS30 Skin Pain Response through Week 52	Proportion of participants achieving NRS30 (≥30% and ≥2-unit reduction in skin pain intensity).	Up to Week 52
Change from baseline in AN Count through Week 52	Absolute and percentage change in AN count relative to baseline.	Up to Week 52
Number of participants with Adverse Events through Week 52	Number of participants with safety and tolerability assessments	Up to Week 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): September 25, 2029
• Study Completion (Estimated): November 5, 2029

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: pain; safety; monoclonal antibody; efficacy; AIN457; secukinumab; HiSCR; IL-17A; Moderate to severe hidradenitis suppurativa (HS)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain; Hidradenitis Suppurativa; secukinumab
• Other Study ID Numbers: CAIN457M2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No