Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827798
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 and LOU064 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825 and LOU064 have an adequate clinical profile for further clinical development.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: CFZ533 Drug: Placebo to CFZ533 Drug: LYS006 Drug: Placebo to LYS006 Drug: MAS825 Drug: Placebo to MAS825 Drug: LOU064 25mg Drug: LOU064 100mg Drug: Placebo to LOU064 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : August 22, 2022
Estimated Study Completion Date : June 16, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CFZ533
s.c.
Drug: CFZ533
s.c.

Experimental: LYS006
p.o.
Drug: LYS006
p.o.

Placebo Comparator: Placebo to CFZ533
Matching placebo (s.c.)
Drug: Placebo to CFZ533
s.c.

Placebo Comparator: Placebo to LYS006
Matching placebo (p.o.)
Drug: Placebo to LYS006
p.o.

Experimental: MAS825
s.c.
Drug: MAS825
s.c.

Placebo Comparator: Placebo to MAS825
Matching placebo (s.c.)
Drug: Placebo to MAS825
s.c.

Active Comparator: LOU064 25mg
p.o.
Drug: LOU064 25mg
p.o.

Active Comparator: LOU064 100mg
p.o.
Drug: LOU064 100mg
p.o.

Placebo Comparator: Placebo to LOU064
Matching placebo p.o.
Drug: Placebo to LOU064
p.o.




Primary Outcome Measures :
  1. Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 16 weeks ]
    Proportion of patients achieving clinical response after 16 weeks of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827798


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Layout table for location information
United States, Florida
Novartis Investigative Site Recruiting
Orange Park, Florida, United States, 32073
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Novartis Investigative Site Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Indiana
Novartis Investigative Site Recruiting
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Nebraska
Novartis Investigative Site Withdrawn
Omaha, Nebraska, United States, 68144
United States, Pennsylvania
Novartis Investigative Site Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Austria
Novartis Investigative Site Recruiting
Graz, Austria, 8036
Novartis Investigative Site Recruiting
Wien, Austria, A 1090
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1070
Czechia
Novartis Investigative Site Recruiting
Prague, Prague 1, Czechia, 11000
Denmark
Novartis Investigative Site Recruiting
Copenhagen NV, Denmark, 2400
Novartis Investigative Site Recruiting
Roskilde, Denmark, 4000
France
Novartis Investigative Site Recruiting
Lyon, France, 69437
Novartis Investigative Site Recruiting
Marseille Cedex 05, France, 13885
Novartis Investigative Site Recruiting
Nice Cedex, France, 06202
Novartis Investigative Site Recruiting
Rouen Cedex, France, 76031
Germany
Novartis Investigative Site Recruiting
Bochum, Germany, 44791
Novartis Investigative Site Withdrawn
Darmstadt, Germany, 64297
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Withdrawn
Halle (Saale), Germany, 06108
Novartis Investigative Site Withdrawn
Koeln, Germany, 50937
Novartis Investigative Site Recruiting
Schwerin, Germany, 19055
Hungary
Novartis Investigative Site Completed
Budapest, Hungary, 1085
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Recruiting
Pecs, Hungary, 7623
Novartis Investigative Site Completed
Szeged, Hungary, H 6725
Iceland
Novartis Investigative Site Recruiting
Kopavogur, Iceland, 201
Netherlands
Novartis Investigative Site Recruiting
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Recruiting
Rotterdam, Netherlands, 3015 CE
Spain
Novartis Investigative Site Recruiting
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Recruiting
Barcelona, Spain, 08041
Novartis Investigative Site Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Novartis Investigative Site Recruiting
Madrid, Spain, 28031
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03827798    
Other Study ID Numbers: CCFZ533H12201BC
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hidradenitis suppurativa, acne inversa, platform study
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs