A Phase 4 interventional study of Secukinumab in Hidradenitis Suppurativa (HS), sponsored by Novartis Pharmaceuticals. Recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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).
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).
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's planned enrollment of 36 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with moderate to severe HS at baseline defined as:
Exclusion Criteria:
Participants receive secukinumab administered every two weeks (Q2W) at the specified dose
Drug: Secukinumab
Participants receive secukinumab administered every four weeks (Q4W) at the specified dose
Drug: Secukinumab
secukinumab 300 mg s.c. administered Q2W or Q4W
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.
Time frame: Week 16
Percentage change from baseline in AN Count at Week 16
Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to Week 52
Change from baseline in AN Count through Week 52
Absolute and percentage change in AN count relative to baseline.
Time frame: Up to Week 52
Number of participants with Adverse Events through Week 52
Number of participants with safety and tolerability assessments
Time frame: Up to Week 52
Plan to share: Yes — 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
No publications or documents are linked to this record.
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