Last Update: Dec 21, 2023
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CCFZ533H12201BC
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Hidradenitis Suppurativa
Phase 2
Recruiting
245
Feb 27, 2019
Oct 23, 2026
All
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug

CFZ533

s.c.
Drug

LOU064 100mg

p.o.
Drug

LOU064 25mg

p.o.
Drug

LYS006

p.o.
Drug

MAS825

s.c.
Drug

Placebo to CFZ533

s.c.
Drug

Placebo to LOU064

p.o.
Drug

Placebo to LYS006

p.o.
Drug

Placebo to MAS825

s.c.
Drug

Placebo to VAY736

s.c.
Drug

VAY736

s.c.

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

Study Location

Novartis Investigative Site

Recruiting

Graz,8036,Austria

Novartis Investigative Site

Recruiting

Bruxelles,1070,Belgium

Novartis Investigative Site

Recruiting

Marseille Cedex 05,13885,France

Novartis Investigative Site

Recruiting

Nice,06202,France

Novartis Investigative Site

Recruiting

Reims,51100,France

Novartis Investigative Site

Recruiting

Rouen Cedex,76031,France

Novartis Investigative Site

Recruiting

Antony,92160,France

Novartis Investigative Site

Recruiting

Lyon,69437,France

Novartis Investigative Site

Recruiting

Frankfurt,60590,Germany

Novartis Investigative Site

Recruiting

Bochum,44791,Germany

Novartis Investigative Site

Recruiting

Hamburg,20246,Germany

Novartis Investigative Site

Recruiting

Debrecen,4032,Hungary

Novartis Investigative Site

Recruiting

Sabadell,Barcelona,08208,Spain

Novartis Investigative Site

Recruiting

Barcelona,08041,Spain

Novartis Investigative Site

Recruiting

Madrid,28031,Spain

Novartis Investigative Site

Recruiting

Granada,18012,Spain

Novartis Investigative Site

Recruiting

Manises,Valencia,46940,Spain

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46026,Spain

Novartis Investigative Site

Recruiting

Las Palmas de Gran Canaria,35010,Spain

Novartis Investigative Site

Recruiting

Tampa,Florida,33609,United States

Novartis Investigative Site

Recruiting

Tampa,Florida,33612,United States

Novartis Investigative Site

Recruiting

Charleston,South Carolina,29425,United States

Novartis Investigative Site

Recruiting

Indianapolis,Indiana,46256,United States

Novartis Investigative Site

Recruiting

Evanston,Illinois,60201,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals