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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827798
• Other study ID #: CCFZ533H12201BC
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

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