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

May 8, 2026 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Secukinumab
Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients who experience a change in disease severity classification
Time Frame: Baseline, month 12

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients overall who experience a change in disease severity classification
Time Frame: Baseline, Month 3, Month 6

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)
Time Frame: Baseline, Month 3, Month 6, Month 12

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)
Time Frame: Baseline, Month 3, Month 6, Month 12

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
Time Frame: Baseline, Month 3, Month 6, Month 12
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
Time Frame: Baseline
Descriptive summaries demographic and clinical variables
Baseline
Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W)
Time Frame: Month 3, Month 6, Month 12
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)
Time Frame: Month 3, Month 6, Month 12
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 Frame: Month 3, Month 6, Month 12
Time to secukinumab up- and down-titration
Month 3, Month 6, Month 12
Proportion of patients experiencing adverse events post-secukinumab initiation
Time Frame: Up to 12 Months
Proportion of patients experiencing adverse events post-secukinumab initiation
Up to 12 Months
Proportion of patients experiencing serious adverse events post-secukinumab initiation
Time Frame: Up to 12 Months
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
Time Frame: Up to 12 Months
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
Time Frame: Up to 12 Months
Proportion of patients who discontinued secukinumab due to adverse events
Up to 12 Months
Proportion of patients receiving additional HS-related therapies
Time Frame: Month 3, Month 6, Month 12
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
Time Frame: Month 3, Month 6, Month 12
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
Time Frame: Month 3, Month 6, Month 12
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
Time Frame: Up to 12 Months
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
Time Frame: Up to 12 Months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAIN457MCA01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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