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
Who is this study for? Patients with moderate to severe hidradenitis suppurativa
Status: Active_not_recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
• 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
Locations
United States
Florida
Olympian Clinical Research .
Clearwater
Park Avenue Dermatology, PA
Orange Park
University of South Florida
Tampa
Georgia
Advanced Medical Research
Sandy Springs
Illinois
NorthShore University Health System North Shore
Skokie
Indiana
Dawes Fretzin Clinical Rea Group
Indianapolis
Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey
South Carolina
Medical University of South Carolina MUSC .
Charleston
Other Locations
Austria
Novartis Investigative Site
Graz
Belgium
Novartis Investigative Site
Brussels
Denmark
Novartis Investigative Site
Kobenhavn N V
Novartis Investigative Site
Roskilde
France
Novartis Investigative Site
Antony
Novartis Investigative Site
Lyon
Novartis Investigative Site
Marseille
Novartis Investigative Site
Nice
Novartis Investigative Site
Reims
Novartis Investigative Site
Rouen
Germany
Novartis Investigative Site
Bochum
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Schwerin
Hungary
Novartis Investigative Site
Budapest
Novartis Investigative Site
Debrecen
Novartis Investigative Site
Pécs
Novartis Investigative Site
Szeged
Iceland
Novartis Investigative Site
Kopavogur
Netherlands
Novartis Investigative Site
Groningen
Novartis Investigative Site
Rotterdam
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Granada
Novartis Investigative Site
Las Palmas De Gran Canaria
Novartis Investigative Site
Manises
Novartis Investigative Site
Sabadell
Novartis Investigative Site
Valencia
Time Frame
Start Date: 2019-02-27
Completion Date: 2026-12-11
Participants
Target number of participants: 248
Treatments
Experimental: CFZ533
s.c.
Experimental: LYS006
p.o.
Placebo_comparator: Placebo to CFZ533
Matching placebo (s.c.)
Placebo_comparator: Placebo to LYS006
Matching placebo (p.o.)
Experimental: MAS825
s.c.
Placebo_comparator: Placebo to MAS825
Matching placebo (s.c.)
Active_comparator: LOU064 25mg
p.o.
Active_comparator: LOU064 100mg
p.o.
Placebo_comparator: Placebo to LOU064
Matching placebo p.o.
Experimental: VAY736
s.c.
Placebo_comparator: Placebo to VAY736
Matching placebo (s.c.)
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals