A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov processed this data on September 13, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS(See Contacts and Locations)
Verified September 2024 by Novartis Pharmaceuticals
Sponsor
Novartis PharmaceuticalsInformation Provided by (Responsible Party)
Novartis PharmaceuticalsClinicaltrials.gov Identifier
NCT04179175Other Study ID Numbers: CAIN457M2301E1
First Submitted: November 25, 2019
First Posted: November 27, 2019
Results First Posted: June 21, 2024
Last Update Posted: September 19, 2024
Last Verified: September 2024
History of Changes
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Study Description
This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two Secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268.Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260.
Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.
| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
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| Actual Enrollment | 701 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| Official Title | A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa |
| Study Start Date | March 18, 2020 |
| Actual Primary Completion Date | May 26, 2023 |
| Anticipated Study Completion Date | July 15, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Reponders [Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.] Loss of response was defined as:
at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN.
at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks
Secondary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events [Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.] To assess the long-term safety and tolerability of secukinumab in subjects with moderate to severe HS
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Novartis Pharmaceuticals |
|---|---|
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Study Documents (Full Text)
- Documents Provided by Novartis Pharmaceuticals: Study Protocol May 28, 2020
- Documents Provided by Novartis Pharmaceuticals: Statistical Analysis Plan June 22, 2023
More 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