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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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Hidradenitis Suppurativa |
| Interventions |
Drug: Secukinumab Drug: Placebo |
| Enrollment | 545 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Participants enrolled in 132 study sites worldwide. |
| Arm/Group Title | AIN457 Q2W | AIN457 Q4W | Placebo | Placebo - Re-randomized to AIN457 Q2W | Placebo - Re-randomized to AIN457 Q4W |
|---|---|---|---|---|---|
 Arm/Group Description |
Secukinumab 300mg every 2 weeks (Treatment Period 1 and 2) | Secukinumab 300mg every 4 weeks (Treatment Period 1 and 2) | Placebo group to secukinumab 300mg (Treatment Period 1) | Placebo group, re-randomized to secukinumab 300mg Q2W at week 16 (Treatment Period 2) | Placebo group, re-randomized to secukinumab 300mg Q4W at week 16 (Treatment Period 2) |
| Period Title: Treatment Period 1 (Until Week 16) | |||||
| Started | 181 [1] | 180 | 183 | 0 | 0 |
| Full Analysis Set | 180 | 180 | 183 | 0 | 0 |
| Completed | 170 | 169 | 167 | 0 | 0 |
| Not Completed | 11 | 11 | 16 | 0 | 0 |
| Reason Not Completed | |||||
| Withdrawal by Subject | 6 | 6 | 8 | 0 | 0 |
| Adverse Event | 1 | 4 | 4 | 0 | 0 |
| Lost to Follow-up | 1 | 1 | 1 | 0 | 0 |
| Lack of Efficacy | 1 | 0 | 1 | 0 | 0 |
| Technical problems | 1 | 0 | 1 | 0 | 0 |
| Pregnancy | 0 | 0 | 1 | 0 | 0 |
| Misrandomized Subject | 1 | 0 | 0 | 0 | 0 |
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[1]
1 patient was mis randomized and excluded from the full analysis set.
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| Period Title: Treatment Period 2 (After Week 16) | |||||
| Started | 170 | 169 | 0 | 81 | 86 |
| Completed | 149 | 133 | 0 | 68 | 69 |
| Not Completed | 21 | 36 | 0 | 13 | 17 |
| Reason Not Completed | |||||
| Withdrawal by Subject | 9 | 18 | 0 | 9 | 12 |
| Adverse Event | 6 | 3 | 0 | 2 | 1 |
| Lack of Efficacy | 3 | 3 | 0 | 1 | 2 |
| Lost to Follow-up | 1 | 8 | 0 | 1 | 0 |
| Physician Decision | 1 | 2 | 0 | 0 | 2 |
| Technical Problems | 1 | 0 | 0 | 0 | 0 |
| Death | 0 | 1 | 0 | 0 | 0 |
| Pregnancy | 0 | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | AIN457 Q2W | AIN457 Q4W | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Secukinumab 300mg every 2 weeks | Secukinumab 300mg every 4 weeks | Placebo group to secukinumab 300mg | Total of all reporting groups | |
| Overall Number of Baseline Participants | 180 | 180 | 183 | 543 | |
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Baseline Analysis Population Description |
Full Analysis Set (FAS)
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
| Number Analyzed | 180 participants | 180 participants | 183 participants | 543 participants | |
| 37.3 (11.48) | 35.5 (11.41) | 36.2 (11.25) | 36.3 (11.38) | ||
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 180 participants | 180 participants | 183 participants | 543 participants |
| Between 18 and 65 years | 177 | 178 | 181 | 536 | |
| >=65 years | 3 | 2 | 2 | 7 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
| Number Analyzed | 180 participants | 180 participants | 183 participants | 543 participants | |
| Female |
98 54.4%
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103 57.2%
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105 57.4%
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306 56.4%
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| Male |
82 45.6%
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77 42.8%
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78 42.6%
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237 43.6%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
|||||
| Number Analyzed | 180 participants | 180 participants | 183 participants | 543 participants | |
| White |
133 73.9%
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139 77.2%
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143 78.1%
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415 76.4%
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| Black or African American |
18 10.0%
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19 10.6%
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12 6.6%
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49 9.0%
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| Asian |
16 8.9%
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16 8.9%
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19 10.4%
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51 9.4%
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|
| Native Hawaiian or Other Pacific Islander |
1 0.6%
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0 0.0%
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0 0.0%
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1 0.2%
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|
| American Indian or Alaska native |
7 3.9%
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5 2.8%
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8 4.4%
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20 3.7%
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| Multiple |
4 2.2%
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1 0.6%
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1 0.5%
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6 1.1%
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| Not Reported |
1 0.6%
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0 0.0%
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0 0.0%
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1 0.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | +1 (862) 778-8300 |
| EMail: | novartis.email@novartis.com |
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT03713632 |
| Other Study ID Numbers: |
CAIN457M2302 2018-002062-39 ( EudraCT Number ) |
| First Submitted: | October 18, 2018 |
| First Posted: | October 22, 2018 |
| Results First Submitted: | July 12, 2023 |
| Results First Posted: | August 2, 2023 |
| Last Update Posted: | November 1, 2023 |