Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE)
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| ClinicalTrials.gov Identifier: NCT03713632 |
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Recruitment Status :
Completed
First Posted : October 22, 2018
Results First Posted : August 2, 2023
Last Update Posted : November 1, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hidradenitis Suppurativa | Drug: Secukinumab Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 545 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| 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) |
| Actual Study Start Date : | February 25, 2019 |
| Actual Primary Completion Date : | September 23, 2021 |
| Actual Study Completion Date : | July 19, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Secukinumab 1
Secukinumab 300mg every 2 weeks
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Drug: Secukinumab
Secukinumab 300mg every 2 or every 4 weeks |
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Active Comparator: Secukinumab 2
Secukinumab 300mg every 4 weeks
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Drug: Secukinumab
Secukinumab 300mg every 2 or every 4 weeks |
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Placebo Comparator: Placebo 1
Placebo group to secukinumab 300mg every 2 weeks
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Drug: Placebo
Placebo 300mg every 2 or every 4 weeks |
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Placebo Comparator: Placebo 2
Placebo group to secukinumab 300mg every 4 weeks
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Drug: Placebo
Placebo 300mg every 2 or every 4 weeks |
- Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) [ Time Frame: 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.
- Percentage Change From Baseline in AN Count [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- -Written informed consent must be obtained before any assessment is performed.
- Male and female patients ≥ 18 years of age.
- Diagnosis of HS ≥ 1 year prior to baseline.
- Patients with moderate to severe HS defined as:
- A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
- Inflammatory lesions should affect at least 2 distinct anatomic areas
- Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.
Exclusion Criteria:
- Total fistulae count ≥ 20 at baseline.
- Any other active skin disease or condition that may interfere with assessment of HS.
- Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
- Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
- History of hypersensitivity to any of the study drug constituents.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- Pregnant or lactating women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713632
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| Study Director: | Study Lead Study Director | Novartis |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03713632 |
| Other Study ID Numbers: |
CAIN457M2302 2018-002062-39 ( EudraCT Number ) |
| First Posted: | October 22, 2018 Key Record Dates |
| Results First Posted: | August 2, 2023 |
| Last Update Posted: | November 1, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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acne inversa Hidradenitis suppurativa maladie de Verneuil inflammatory disease AIN457 AIN457M |
secukinumab HS lumps skin lesions |
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |