Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT03827798
Last Updated: 2026-02-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
248 participants
INTERVENTIONAL
2019-02-27
2026-12-11
Brief Summary
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Detailed Description
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All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period.
All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort E - Placebo to VAY736
Placebo administered s.c every 4 weeks until Week 13.
Placebo to VAY736
Placebo administered s.c every 4 weeks until Week 13.
Cohort A - CFZ533 600 mg
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
CFZ533
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Cohort B - LYS006 20 mg
LYS006 20 mg administered orally twice per day until Week 16.
LYS006
LYS006 20 mg administered orally twice per day until Week 16.
Cohort A - Placebo to CFZ533
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Placebo to CFZ533
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Cohort B - Placebo to LYS006
Placebo administered orally twice per day until Week 16.
Placebo to LYS006
Placebo administered orally twice per day until Week 16.
Cohort C - MAS825 300 mg
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
MAS825
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Cohort C - Placebo to MAS825
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Placebo to MAS825
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Cohort D - LOU064 25mg
LOU064 25 mg administered orally twice per day until Week 16.
LOU064 25mg
LOU064 25 mg administered orally twice per day until Week 16.
Cohort D - LOU064 100mg
LOU064 100 mg administered orally twice per day until Week 16.
LOU064 100mg
LOU064 100 mg administered orally twice per day until Week 16.
Cohort D - Placebo to LOU064
Placebo administered orally twice per day until Week 16.
Placebo to LOU064
Placebo administered orally twice per day until Week 16.
Cohort E - VAY736 300 mg
VAY736 300 mg administered s.c every 4 weeks until Week 13.
VAY736
VAY736 300 mg administered s.c every 4 weeks until Week 13.
Interventions
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CFZ533
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Placebo to CFZ533
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
LYS006
LYS006 20 mg administered orally twice per day until Week 16.
Placebo to LYS006
Placebo administered orally twice per day until Week 16.
MAS825
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Placebo to MAS825
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
LOU064 25mg
LOU064 25 mg administered orally twice per day until Week 16.
LOU064 100mg
LOU064 100 mg administered orally twice per day until Week 16.
Placebo to LOU064
Placebo administered orally twice per day until Week 16.
VAY736
VAY736 300 mg administered s.c every 4 weeks until Week 13.
Placebo to VAY736
Placebo administered s.c every 4 weeks until Week 13.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimal body weight of 50 kg
* Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule
Exclusion Criteria
* Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
* Pregnant or lactating women
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Olympian Clinical Research
Clearwater, Florida, United States
Park Avenue Dermatology PA
Orange Park, Florida, United States
University Of South Florida
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
NorthShore University Health System
Evanston, Illinois, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina MUSC
Charleston, South Carolina, United States
Novartis Investigative Site
Graz, , Austria
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Prague, Prague 1, Czechia
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Roskilde, , Denmark
Novartis Investigative Site
Antony, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Reims, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Schwerin, , Germany
Novartis Investigative Site
Pécs, Baranya, Hungary
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Kopavogur, , Iceland
Novartis Investigative Site
Rotterdam, South Holland, Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Manises, Valencia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Las Palmas GC, , Spain
Novartis Investigative Site
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CCFZ533H12201BC
Identifier Type: -
Identifier Source: org_study_id
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