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NCT Number: NCT07282015

Real-world Secukinumab Outcomes in Canadian HS Patients

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.

Recruiting

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Descriptive summaries of demographic and clinical variables

    Time frame: Baseline

    Descriptive summaries demographic and clinical variables

  6. 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

  7. 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

  8. Time to secukinumab up- and down-titration

    Time frame: Month 3, Month 6, Month 12

    Time to secukinumab up- and down-titration

  9. Proportion of patients experiencing adverse events post-secukinumab initiation

    Time frame: Up to 12 Months

    Proportion of patients experiencing adverse events post-secukinumab initiation

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Reason(s) for secukinumab discontinuation

    Time frame: Up to 12 Months

    Reason(s) for secukinumab discontinuation; additional subgroup analyses by ethnicity/race

  17. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: HS-RISE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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