A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)
ClinicalTrials.gov processed this data on October 7, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified October 2024 by Novartis Pharmaceuticals
Sponsor
Novartis PharmaceuticalsInformation Provided by (Responsible Party)
Novartis PharmaceuticalsClinicaltrials.gov Identifier
NCT03713632Other Study ID Numbers: CAIN457M2302
First Submitted: October 18, 2018
First Posted: October 22, 2018
Results First Posted: August 2, 2023
Last Update Posted: October 9, 2024
Last Verified: October 2024
History of Changes
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Study Description
This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in patients with moderate to severe HS. The study consisted of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included.In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.
| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
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| Actual Enrollment | 545 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| Official Title | A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE) |
| Study Start Date | February 25, 2019 |
| Actual Primary Completion Date | September 23, 2021 |
| Actual Study Completion Date | July 19, 2022 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) [16 weeks] HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration.
This endpoint was analyzed by logistic regression.
Secondary Outcome Measures
- Percentage Change From Baseline in AN Count [Baseline, 16 weeks] Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.
- Percentage of Participants With Hidradenitis Suppurativa (HS) Flares [16 weeks] Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline.
This endpoint was analyzed by logistic regression. - Percentage of Participants Achieving NRS30 [16 weeks] Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain]).
This endpoint was analyzed by logistic regression.
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
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Contacts and Locations
| Sponsors and Collaborators | Novartis Pharmaceuticals |
|---|---|
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| Investigators |
Study Documents (Full Text)
- Documents Provided by Novartis Pharmaceuticals: Study Protocol January 8, 2021
- Documents Provided by Novartis Pharmaceuticals: Statistical Analysis Plan July 21, 2022
More Information
Additional Information
Additional Relevant MeSH Terms
- Hidradenitis Suppurativa
- Hidradenitis
- Sweat Gland Diseases
- Skin Diseases
- Skin Diseases, Bacterial
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Skin Diseases, Infectious
- Suppuration