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)
1 other identifier
observational
142
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedStudy Start
First participant enrolled
December 12, 2025
CompletedFirst Posted
Study publicly available on registry
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 11, 2028
April 15, 2026
April 1, 2026
2.2 years
December 2, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Proportion of patients overall who experience a change in disease severity classification
Baseline, Month 3, Month 6
Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55)
Baseline, Month 3, Month 6, Month 12
Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50)
Baseline, Month 3, Month 6, Month 12
Mean reduction in abscess and inflammatory nodule count
Baseline, Month 3, Month 6, Month 12
Descriptive summaries of demographic and clinical variables
Baseline
- +12 more secondary outcomes
Study Arms (1)
Secukinumab
Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice
Eligibility Criteria
Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice
You may qualify if:
- Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed.
- Adult patients at the time of informed consent signature.
- Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist.
- 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.
- Patients who can understand written and spoken Canadian English or French.
You may not qualify if:
- Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation.
- Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM.
- Patients who have had any prior exposure to secukinumab (i.e., \>7 days prior to the baseline visit).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Novartis Investigative Site
Calgary, Alberta, T2J 7E1, Canada
Novartis Investigative Site
Winnipeg, Manitoba, R3M 3Z4, Canada
Novartis Investigative Site
Cobourg, Ontario, K9A 4J9, Canada
Novartis Investigative Site
Hamilton, Ontario, L8P4B4, Canada
Novartis Investigative Site
London, Ontario, N6H 5L5, Canada
Novartis Investigative Site
Markham, Ontario, L3P 1X3, Canada
Novartis Investigative Site
Mississauga, Ontario, L4W 0C2, Canada
Novartis Investigative Site
Richmond Hill, Ontario, L4C 9M7, Canada
Novartis Investigative Site
Toronto, Ontario, M4E 1R7, Canada
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1L 0H8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 15, 2025
Study Start
December 12, 2025
Primary Completion (Estimated)
February 11, 2028
Study Completion (Estimated)
February 11, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share