Real-world Secukinumab Outcomes in Canadian HS Patients (HS-RISE)

A Prospective Study to Describe the Real-world Treatment Outcomes in Canadian Patients With Moderate-to-severe Hidradenitis Suppurativa Treated With secukInumab (HS-RISE)

The HS-RISE study aims to assess real-world HS treatment outcomes and patterns, safety of secukinumab, and to describe the baseline characteristics of patients diagnosed with moderate-to- severe HS who are prescribed secukinumab in Canadian routine clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa

• Study Type: Observational
• Enrollment (Estimated): 142

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Novartis Investigative Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Recruiting
      • Novartis Investigative Site
  • Ontario
    • Cobourg, Ontario, Canada, K9A 4J9
      • Recruiting
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8P4B4
      • Recruiting
      • Novartis Investigative Site
    • London, Ontario, Canada, N6H 5L5
      • Recruiting
      • Novartis Investigative Site
    • Markham, Ontario, Canada, L3P 1X3
      • Recruiting
      • Novartis Investigative Site
    • Mississauga, Ontario, Canada, L4W 0C2
      • Recruiting
      • Novartis Investigative Site
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Recruiting
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M4E 1R7
      • Recruiting
      • Novartis Investigative Site
  • Quebec
    • Saint-Jérôme, Quebec, Canada, J7Z 7E2
      • Recruiting
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Recruiting
      • Novartis Investigative Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N0N5
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice

Description

Inclusion Criteria:

1. Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed.
2. Adult patients at the time of informed consent signature.
3. Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist.
4. Patients who have been newly prescribed secukinumab as part of routine clinical care according to the approved Canadian PM. The decision to prescribe secukinumab must be made prior to,and independent of, study participation. First treatment with secukinumab must occur no more than 7 days (≤7 days) prior to Baseline visit.
5. Patients who can understand written and spoken Canadian English or French.

Exclusion Criteria:

1. Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation.
2. Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM.
3. Patients who have had any prior exposure to secukinumab (i.e., >7 days prior to the baseline visit).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Secukinumab; Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who experience a change in disease severity classification	Proportion of patients who experience a change in disease severity classification from baseline to 12 months, as determined by the International HS Severity Score System (IHS4). Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.	Baseline, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients overall who experience a change in disease severity classification	Proportion of patients overall who experience a change in disease severity classification as determined by IHS4 from baseline at Months 3 and 6; additional subgroups analyses by ethnicity/race. Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.	Baseline, Month 3, Month 6
Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55)	Proportion of patients achieving IHS4-55 at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. IHS4-55 is defined as at least a 55% reduction in their IHS4 from baseline.	Baseline, Month 3, Month 6, Month 12
Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50)	Proportion of patients achieving a 50% reduction from baseline in HS Clinical Response Score (HiSCR50) at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscesses or draining fistulae count.	Baseline, Month 3, Month 6, Month 12
Mean reduction in abscess and inflammatory nodule count	Mean reduction in abscess and inflammatory nodule count from baseline at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race	Baseline, Month 3, Month 6, Month 12
Descriptive summaries of demographic and clinical variables	Descriptive summaries demographic and clinical variables	Baseline
Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W)	Proportion of patients receiving secukinumab up-titration from Q4W to Q2W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation	Month 3, Month 6, Month 12
Proportion of patients receiving secukinumab down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W)	Proportion of patients receiving secukinumab down-titration from Q2W to Q4W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation	Month 3, Month 6, Month 12
Time to secukinumab up- and down-titration	Time to secukinumab up- and down-titration	Month 3, Month 6, Month 12
Proportion of patients experiencing adverse events post-secukinumab initiation	Proportion of patients experiencing adverse events post-secukinumab initiation	Up to 12 Months
Proportion of patients experiencing serious adverse events post-secukinumab initiation	Proportion of patients experiencing serious adverse events post-secukinumab initiation	Up to 12 Months
Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation	Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation	Up to 12 Months
Proportion of patients who discontinued secukinumab due to adverse events	Proportion of patients who discontinued secukinumab due to adverse events	Up to 12 Months
Proportion of patients receiving additional HS-related therapies	Proportion of patients receiving additional HS-related therapies at Months 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation	Month 3, Month 6, Month 12
Proportion of patients requiring unplanned surgeries	Proportion of patients requiring unplanned surgeries at Month 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation	Month 3, Month 6, Month 12
Proportion of patients discontinuing secukinumab treatment	Proportion of patients discontinuing secukinumab treatment at Months 3, 6, and 12; additional sugbroup analyses also done by ethnicity/race	Month 3, Month 6, Month 12
Reason(s) for secukinumab discontinuation	Reason(s) for secukinumab discontinuation; additional subgroup analyses by ethnicity/race	Up to 12 Months
Percentage of no-show appointments which were scheduled as per standard of care	Percentage of no-show appointments which were scheduled as per standard of care with participating dermatologist (including injections) and the corresponding reason(s); additional subgroup analyses by ethnicity/race	Up to 12 Months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): February 11, 2028

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase IV; NIS; secukinumab; Hidradenitis Suppurativa
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: CAIN457MCA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO