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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03827798
Other study ID # CCFZ533H12201BC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 27, 2019
Est. completion date October 23, 2026

Study information

Verified date April 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 245
Est. completion date October 23, 2026
Est. primary completion date November 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
CFZ533
s.c.
Placebo to CFZ533
s.c.
LYS006
p.o.
Placebo to LYS006
p.o.
MAS825
s.c.
Placebo to MAS825
s.c.
LOU064 25mg
p.o.
LOU064 100mg
p.o.
Placebo to LOU064
p.o.
VAY736
s.c.
Placebo to VAY736
s.c.

Locations

Country Name City State
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Bruxelles
Czechia Novartis Investigative Site Prague Prague 1
Denmark Novartis Investigative Site Copenhagen NV
Denmark Novartis Investigative Site Roskilde
France Novartis Investigative Site Antony
France Novartis Investigative Site Lyon
France Novartis Investigative Site Marseille Cedex 05
France Novartis Investigative Site Nice
France Novartis Investigative Site Reims
France Novartis Investigative Site Rouen Cedex
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Darmstadt
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Halle (Saale)
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Schwerin
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Pecs
Hungary Novartis Investigative Site Szeged
Iceland Novartis Investigative Site Kopavogur
Netherlands Novartis Investigative Site Groningen
Netherlands Novartis Investigative Site Rotterdam
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Granada
Spain Novartis Investigative Site Las Palmas de Gran Canaria
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Manises Valencia
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Valencia
United States Beth Israel Deaconess Medical Cente Boston Massachusetts
United States Medical University of South Carolina MUSC . Charleston South Carolina
United States Olympian Clinical Research . Clearwater Florida
United States Penn State Milton S Hershey Medical Center . Hershey Pennsylvania
United States Dawes Fretzin Clinical Rea Group Indianapolis Indiana
United States Skin Specialists PC . Omaha Nebraska
United States Park Avenue Dermatology, PA Orange Park Florida
United States Advanced Medical Research Sandy Springs Georgia
United States NorthShore University Health System North Shore Skokie Illinois
United States Olympian Clinical Research . Tampa Florida
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  Hungary,  Iceland,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary simplified Hidradenitis Suppurativa Clinical Response (sHiSCR) Proportion of patients achieving clinical response after 16 weeks of treatment 16 weeks
See also
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