Secukinumab outcomes in Canadians with hidradenitis suppurativa

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

It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

Quick facts

• Study type: Observational
• Enrollment: 142 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: secukinumab
• Locations: 13 sites (Calgary, Alberta and 12 other locations)
• Trial ID: NCT07282015 on ClinicalTrials.gov

What this trial studies

This observational, non-interventional study follows adults in Canada with dermatologist-diagnosed moderate-to-severe hidradenitis suppurativa who have been newly prescribed secukinumab as part of routine care. The protocol captures baseline characteristics, treatment patterns, and safety outcomes, with first treatment occurring no more than seven days before the baseline visit. Patients must give informed consent and understand English or French, and participation takes place at Novartis investigative sites in Calgary, Winnipeg, and Fredericton. No additional study-mandated treatments are given; clinicians manage therapy per usual practice and outcomes are recorded over time.

Who should consider this trial

Good fit: Adults in Canada with dermatologist-confirmed moderate-to-severe HS who were newly prescribed secukinumab within seven days before enrollment, can give informed consent, and understand English or French are ideal candidates.

Not a fit: Patients with contraindications to secukinumab, those with medical or psychological conditions preventing participation, or those already on secukinumab for more than seven days are unlikely to benefit from joining.

Why it matters

Potential benefit: If successful, the results could give doctors and patients clearer real-world information about the effectiveness and safety of secukinumab for moderate-to-severe HS in Canadian practice.

How similar studies have performed: Previous clinical trials and smaller studies have shown promising results for secukinumab in HS, but comprehensive real-world evidence in Canadian populations is limited.

Eligibility criteria

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).

Where this trial is running

Calgary, Alberta and 12 other locations

• Novartis Investigative Site — Calgary, Alberta, Canada (Recruiting)
• Novartis Investigative Site — Winnipeg, Manitoba, Canada (Recruiting)
• Novartis Investigative Site — Fredericton, New Brunswick, Canada (Recruiting)
• Novartis Investigative Site — Cobourg, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Hamilton, Ontario, Canada (Recruiting)
• Novartis Investigative Site — London, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Markham, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Mississauga, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Richmond Hill, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Toronto, Ontario, Canada (Recruiting)
• Novartis Investigative Site — Saint-Jérôme, Quebec, Canada (Recruiting)
• Novartis Investigative Site — Sherbrooke, Quebec, Canada (Recruiting)
• Novartis Investigative Site — Saskatoon, Saskatchewan, Canada (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Hidradenitis Suppurativa; NIS; secukinumab; Phase IV