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

Last updated: March 27, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Scalp Disorders

Acne Inversa

Rosacea

Treatment

LOU064 25mg

Placebo to LYS006

MAS825

Clinical Study ID

NCT03827798
CCFZ533H12201BC
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with moderate to severe HS based on the number of lesions, fistulae andanatomical areas involved

  • Minimal body weight of 50 kg

  • Able to communicate well with the investigator and understand and comply with therequirements of the study, and the ability and willingness to conduct study visitsas per the study schedule

Exclusion

Exclusion Criteria:

  • Use of other investigational drugs at the time of screening or before

  • Women physiologically capable of becoming pregnant, unless they are using highlyeffective methods of contraception

  • Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 248
Treatment Group(s): 11
Primary Treatment: LOU064 25mg
Phase: 2
Study Start date:
February 27, 2019
Estimated Completion Date:
December 10, 2026

Connect with a study center

  • Novartis Investigative Site

    Graz, 8036
    Austria

    Site Not Available

  • Novartis Investigative Site

    Wien, A 1090
    Austria

    Site Not Available

  • Novartis Investigative Site

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Prague, Prague 1 11000
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Copenhagen NV, 2400
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Kobenhavn N V, 2400
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Roskilde, 4000
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Antony, 92160
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon, 69003
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille Cedex 05, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Nice, 06202
    France

    Site Not Available

  • Novartis Investigative Site

    Nice Cedex, 06202
    France

    Site Not Available

  • Novartis Investigative Site

    Reims, 51100
    France

    Site Not Available

  • Novartis Investigative Site

    Rouen, 76031
    France

    Site Not Available

  • Novartis Investigative Site

    Rouen Cedex, 76031
    France

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Darmstadt, 64297
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle (Saale), 06108
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle Saale, 06108
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwerin, 19055
    Germany

    Site Not Available

  • Novartis Investigative Site

    Budapest, H-1083
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Pecs, 7623
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, H 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Kopavogur, 201
    Iceland

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Granada, Andalucia 18014
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Novartis Investigative Site

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, 08041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28031
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Site Not Available

  • Olympian Clinical Research .

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Novartis Investigative Site

    Orange Park, Florida 32073
    United States

    Completed

  • Park Avenue Dermatology, PA

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Novartis Investigative Site

    Tampa, Florida 33609
    United States

    Site Not Available

  • Olympian Clinical Research .

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Advanced Medical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Novartis Investigative Site

    Sandy Springs, Georgia 30328
    United States

    Completed

  • Novartis Investigative Site

    Evanston, Illinois 60201
    United States

    Site Not Available

  • NorthShore University Health System North Shore

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Novartis Investigative Site

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novartis Investigative Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Skin Specialists PC .

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Novartis Investigative Site

    Hershey, Pennsylvania 17033-0850
    United States

    Completed

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center .

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Medical University of South Carolina MUSC .

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novartis Investigative Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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