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Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
Sponsor: Novartis Pharmaceuticals
Summary
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
Official title: A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2019-02-27
Completion Date
2026-12-11
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (36)
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