Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
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
2 other identifiers
interventional
703
37 countries
188
Brief Summary
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2020
Longer than P75 for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedStudy Start
First participant enrolled
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2023
CompletedResults Posted
Study results publicly available
June 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
ExpectedMarch 11, 2026
March 1, 2026
3.2 years
November 25, 2019
May 24, 2024
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
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
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.
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand. * Day 1 = Date of 1st dose intake in the extension study. * Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval. * Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100.
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.
Secondary Outcomes (1)
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.
Study Arms (5)
secukinumab 1 HiSCR Responder
ACTIVE COMPARATORHiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks
secukinumab 2 HiSCR Responder
ACTIVE COMPARATORHiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks
placebo 1 HiSCR Responder
PLACEBO COMPARATORHiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks
placebo 2 HiSCR Responder
PLACEBO COMPARATORHiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks
HiSCR non-responders
OTHERnon-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks
Interventions
secukinumab 300mg every 2 weeks
Eligibility Criteria
You may qualify if:
- written informed consent must be obtained before any assessment is performed
- subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during Treatment Period 2
You may not qualify if:
- protocol deviation in the core study which will prevent the meaningful analysis of the extension study
- ongoing or planned use of prohibited HS or non-HS treatment
- participation in the extension could expose the subject to an undue safety risk
- current sever progressive or uncontrolled disease which renders the subject unsuitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (191)
Northwest Arkansas Center
Rogers, Arkansas, 72758, United States
MedDerm Associates
San Diego, California, 92103, United States
University Clinical Trials
San Diego, California, 92123, United States
Southern California Skin and Laser
Whittier, California, 92677, United States
Florida Academic Centers Research and Education LLC
Coral Gables, Florida, 33134, United States
University of MiamiHealth System
Miami, Florida, 33125, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
University Of South Florida
Tampa, Florida, 33612, United States
Advanced Medical Research
Sandy Springs, Georgia, 30328, United States
Endeavor Health
Glenview, Illinois, 60077, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, 02215, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
St Louis U Clinical Trials
St Louis, Missouri, 63104, United States
WA Uni School Of Med
St Louis, Missouri, 63110, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Icahn School Of Med At Mount Sinai
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27516, United States
Wright State University
Fairborn, Ohio, 45324, United States
UP Medical Center H System
Pittsburgh, Pennsylvania, 15213-3403, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, 29407, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
MDRI Baylor University
Dallas, Texas, 75246-1613, United States
Austin Inst for Clinical Research
Pflugerville, Texas, 78660, United States
Dr. Stephen Miller, MDPA
San Antonio, Texas, 78229, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
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Related Publications (1)
Kimball AB, Bechara FG, Badat A, Giamarellos-Bourboulis EJ, Gottlieb AB, Jemec GBE, Reguiai Z, Villani AP, Alarcon I, Bansal A, Gasperoni F, Martin R, Paguet B, Uhlmann L, Zouater H, Ravichandran S, Alavi A. Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial. Br J Dermatol. 2025 Mar 18;192(4):629-640. doi: 10.1093/bjd/ljae469.
PMID: 39611771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Patients considered HiSCR responders will be randomized 2:1 to continue their current regimen or undergo withdrawal to placebo. HiScr non-responders will enter open label therapy with Secukinumab if desired
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
November 27, 2019
Study Start
March 18, 2020
Primary Completion
May 26, 2023
Study Completion (Estimated)
July 15, 2026
Last Updated
March 11, 2026
Results First Posted
June 21, 2024
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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