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
NCT ID: NCT04179175
Last Updated: 2025-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
703 participants
INTERVENTIONAL
2020-03-18
2026-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT03713632
Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.
NCT05921994
Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa
NCT07109765
Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation
NCT06444087
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
NCT06707246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
secukinumab 1 HiSCR Responder
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks
secukinumab
secukinumab 300mg every 2 weeks
secukinumab 2 HiSCR Responder
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks
secukinumab
secukinumab 300mg every 4 weeks
placebo 1 HiSCR Responder
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks
secukinumab
secukinumab 300mg every 2 weeks
placebo 2 HiSCR Responder
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks
secukinumab
secukinumab 300mg every 4 weeks
HiSCR non-responders
non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks
secukinumab
secukinumab 300mg every 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
secukinumab
secukinumab 300mg every 2 weeks
secukinumab
secukinumab 300mg every 4 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Peterborough, Ontario, Canada
Novartis Investigative Site
Waterloo, Ontario, Canada
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Zagreb, HRV, Croatia
Novartis Investigative Site
Prague, Prague 1, Czechia
Novartis Investigative Site
Jihlava, , Czechia
Novartis Investigative Site
Plzen Bory, , Czechia
Novartis Investigative Site
Ústí nad Labem, , Czechia
Novartis Investigative Site
Limoges, Haute Vienne, France
Novartis Investigative Site
Toulon, Val De Marne, France
Novartis Investigative Site
Antony, , France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Brest, , France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Martigues, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Langenau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Würzburg, Bavaria, Germany
Novartis Investigative Site
Halle, Saxony-Anhalt, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Memmingen, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Potsdam, , Germany
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Cona, FE, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Lausanne, , Switzerland
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Novartis Investigative Site
Aydin, Efeler, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Antalya, Konyaalti, Turkey (Türkiye)
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Pendik, Turkey (Türkiye)
Novartis Investigative Site
Gaziantep, Sehitkamil, Turkey (Türkiye)
Novartis Investigative Site
Exeter, Devon, United Kingdom
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Barnsley, , United Kingdom
Novartis Investigative Site
Bristol, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Salford, , United Kingdom
Northwest Arkansas Center
Rogers, Arkansas, United States
MedDerm Associates
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Southern California Skin and Laser
Whittier, California, United States
Florida Academic Centers Research and Education LLC
Coral Gables, Florida, United States
University of MiamiHealth System
Miami, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
University Of South Florida
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Endeavor Health
Glenview, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
St Louis U Clinical Trials
St Louis, Missouri, United States
WA Uni School Of Med
St Louis, Missouri, United States
Skin Specialists PC
Omaha, Nebraska, United States
Icahn School Of Med At Mount Sinai
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wright State University
Fairborn, Ohio, United States
UP Medical Center H System
Pittsburgh, Pennsylvania, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
MDRI Baylor University
Dallas, Texas, United States
Austin Inst for Clinical Research
Pflugerville, Texas, United States
Dr. Stephen Miller, MDPA
San Antonio, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Caba, , Argentina
Novartis Investigative Site
Capital Federal, , Argentina
Novartis Investigative Site
Phillip, Australian Capital Territory, Australia
Novartis Investigative Site
Benowa, Queensland, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Linz, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Pleven, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Stara Zagora, , Bulgaria
Novartis Investigative Site
Barrie, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Reims, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Saint-Mandé, , France
Novartis Investigative Site
Saint-Priest-en-Jarez, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Schwerin, , Germany
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Chaïdári, , Greece
Novartis Investigative Site
Thessaloniki, , Greece
Novartis Investigative Site
Thessaloniki, , Greece
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Mysore, Karnataka, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nashik, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kisarazu, Chiba, Japan
Novartis Investigative Site
Ginowan, Okinawa, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Saida, , Lebanon
Novartis Investigative Site
Kaunas, LTU, Lithuania
Novartis Investigative Site
Vilnius, , Lithuania
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Johor Bahru, , Malaysia
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Amersfroort, Utrecht, Netherlands
Novartis Investigative Site
Las Piñas, , Philippines
Novartis Investigative Site
Makati City, , Philippines
Novartis Investigative Site
Warsaw, Mazowian, Poland
Novartis Investigative Site
Ossy, , Poland
Novartis Investigative Site
Rzeszów, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Kazan', , Russia
Novartis Investigative Site
Krasnodar, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Smolensk, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Banská Bystrica, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Prešov, , Slovakia
Novartis Investigative Site
Raslouw Centurion, Gauteng, South Africa
Novartis Investigative Site
Soweto, Gauteng, South Africa
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Cadiz, Andalusia, Spain
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Fuenlabrada, Madrid, Spain
Novartis Investigative Site
Manises, Valencia, Spain
Novartis Investigative Site
Alicante, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Las Palmas GC, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Pontevedra, , Spain
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Geneva, , Switzerland
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-508956-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAIN457M2301E1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.