Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

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: NCT03827798

Novartis Reference Number: CCFZ533H12201BC

See if you pre-qualify

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 and LYS006 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533 and LYS006 have an adequate clinical profile for further clinical development.

Condition 
Hidradenitis Suppurativa
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
90 participants
Start date 
Feb 27, 2019
Completion date 
Dec 28, 2022
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
CFZ533
s.c.
Drug
Placebo to CFZ533
s.c.
Drug
LYS006
p.o.
Drug
Placebo to LYS006
p.o.

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 Locations

United States
Novartis Investigative Site
Recruiting
Orange Park, 32073
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Sandy Springs, 30328
Georgia
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Omaha, 68144
Nebraska
United States
Novartis Investigative Site
Recruiting
Hershey, 17033-0850
Pennsylvania
United States
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1070
-
Belgium
Denmark
Novartis Investigative Site
Recruiting
Copenhagen NV, 2400
-
Denmark
Novartis Investigative Site
Recruiting
Roskilde, 4000
-
Denmark
France
Novartis Investigative Site
Recruiting
Marseille cedex 05, 13385
-
France
Novartis Investigative Site
Recruiting
Nice, 06202
-
France
Novartis Investigative Site
Recruiting
Rouen Cedex, 76031
-
France
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Recruiting
Darmstadt, 64297
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Halle (Saale), 06108
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Novartis Investigative Site
Recruiting
Schwerin, 19055
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7632
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, H 6725
-
Hungary
Iceland
Novartis Investigative Site
Recruiting
Kopavogur, 201
-
Iceland
Netherlands
Novartis Investigative Site
Recruiting
Groningen, 9713 GZ
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]