Clinical trial NCT03827798: Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa, acne inversa, platform study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Use of other investigational drugs at the time of screening or before
* Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
* Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: simplified Hidradenitis Suppurativa Clinical Response (sHiSCR)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Olympian Clinical Research .
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Skokie
country: United States
facility: NorthShore University Health System North Shore
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Rea Group
state: Indiana
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina MUSC .
state: South Carolina
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Prague
country: Czechia
facility: Novartis Investigative Site
state: Prague 1
city: Kobenhavn N V
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Antony
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Kopavogur
country: Iceland
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
state: Zuid Holland
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Manises
country: Spain
facility: Novartis Investigative Site
state: Valencia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
Study officials:
References: