Hidradenitis SuppurativaHS-RISENCT07282015
Real-world Secukinumab Outcomes in Canadian HS Patients
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 15 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 142 participants
- Where
- 15 sitesCanada
- Study dates
- 12 Dec 2025to 11 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
15 sites in 1 country
Canada15 sites, 15 recruiting
- Recruiting
Novartis Investigative Site
Calgary, Alberta, T2J 7E1
- Recruiting
Novartis Investigative Site
Calgary, Alberta, T3E 0B2
- Recruiting
Novartis Investigative Site
Cobourg, Ontario, K9A 4J9
- Recruiting
Novartis Investigative Site
Fredericton, New Brunswick, E3B 1G9
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8P4B4
- Recruiting
Novartis Investigative Site
London, Ontario, N6H 5L5
- Recruiting
Novartis Investigative Site
Markham, Ontario, L3P 1X3
- Recruiting
Novartis Investigative Site
Mississauga, Ontario, L4W 0C2
- Recruiting
Novartis Investigative Site
Richmond Hill, Ontario, L4C 9M7
- Recruiting
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 7E2
- Recruiting
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N0N5
- Recruiting
Novartis Investigative Site
Sherbrooke, Quebec, J1L 0H8
- Recruiting
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1E 1V4
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M4E 1R7
- Recruiting
Novartis Investigative Site
Winnipeg, Manitoba, R3M 3Z4
About this study
Official 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)
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.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, NIS, secukinumab, Phase IV
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, month 12
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Month 3, Month 6, Month 12
Descriptive summaries of demographic and clinical variables
Descriptive summaries demographic and clinical variables
Measured: 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
Measured: 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
Measured: Month 3, Month 6, Month 12
Time to secukinumab up- and down-titration
Time to secukinumab up- and down-titration
Measured: Month 3, Month 6, Month 12
Proportion of patients experiencing adverse events post-secukinumab initiation
Proportion of patients experiencing adverse events post-secukinumab initiation
Measured: Up to 12 Months
Proportion of patients experiencing serious adverse events post-secukinumab initiation
Proportion of patients experiencing serious adverse events post-secukinumab initiation
Measured: 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
Measured: Up to 12 Months
Proportion of patients who discontinued secukinumab due to adverse events
Proportion of patients who discontinued secukinumab due to adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: Month 3, Month 6, Month 12
Reason(s) for secukinumab discontinuation
Reason(s) for secukinumab discontinuation; additional subgroup analyses by ethnicity/race
Measured: 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
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start12 Dec 2025
- Primary completion11 Feb 2028 (estimated)
- Study completion11 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282015
- Sponsor's protocol ID
- CAIN457MCA01
- Acronym
- HS-RISE
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07282015
- Acronym / sponsor ID
- HS-RISE / CAIN457MCA01
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, NIS, secukinumab, Phase IV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 11 Feb 2028 (estimated)
- Study completion
- 11 Feb 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | – | –Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
17 secondary outcomes
Proportion of patients overall who experience a change in disease severity classification
Time frame: 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 experiencing HS Clinical Response 50 (HiSCRO50)
Time frame: Baseline, Month 3, Month 6, Month 12
Mean reduction in abscess and inflammatory nodule count
Time frame: Baseline, Month 3, Month 6, Month 12
Descriptive summaries of demographic and clinical variables
Time frame: 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 down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W)
Time frame: Month 3, Month 6, Month 12
Time to secukinumab up- and down-titration
Time frame: 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 serious adverse events post-secukinumab initiation
Time frame: Up to 12 Months
Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation
Time frame: Up to 12 Months
Proportion of patients who discontinued secukinumab due to adverse events
Time frame: Up to 12 Months
Proportion of patients receiving additional HS-related therapies
Time frame: Month 3, Month 6, Month 12
Proportion of patients requiring unplanned surgeries
Time frame: Month 3, Month 6, Month 12
Proportion of patients discontinuing secukinumab treatment
Time frame: Month 3, Month 6, Month 12
Reason(s) for secukinumab discontinuation
Time frame: Up to 12 Months
Percentage of no-show appointments which were scheduled as per standard of care
Time frame: Up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience a change in disease severity classification (time frame: Baseline, month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.