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

December 20, 2023 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

245

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Novartis Investigative Site
      • Wien, Austria, A 1090
        • Withdrawn
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Recruiting
        • Novartis Investigative Site
  • Czechia
    • Prague 1
      • Prague, Prague 1, Czechia, 11000
        • Completed
        • Novartis Investigative Site
  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Completed
        • Novartis Investigative Site
      • Roskilde, Denmark, 4000
        • Completed
        • Novartis Investigative Site
  • France
      • Antony, France, 92160
        • Recruiting
        • Novartis Investigative Site
      • Lyon, France, 69437
        • Recruiting
        • Novartis Investigative Site
      • Marseille Cedex 05, France, 13885
        • Recruiting
        • Novartis Investigative Site
      • Nice, France, 06202
        • Recruiting
        • Novartis Investigative Site
      • Reims, France, 51100
        • Recruiting
        • Novartis Investigative Site
      • Rouen Cedex, France, 76031
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Bochum, Germany, 44791
        • Recruiting
        • Novartis Investigative Site
      • Darmstadt, Germany, 64297
        • Withdrawn
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
      • Halle (Saale), Germany, 06108
        • Withdrawn
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Koeln, Germany, 50937
        • Withdrawn
        • Novartis Investigative Site
      • Schwerin, Germany, 19055
        • Completed
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1085
        • Completed
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
      • Pecs, Hungary, 7623
        • Completed
        • Novartis Investigative Site
      • Szeged, Hungary, H 6725
        • Completed
        • Novartis Investigative Site
  • Iceland
      • Kopavogur, Iceland, 201
        • Completed
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Completed
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Completed
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Novartis Investigative Site
      • Granada, Spain, 18012
        • Recruiting
        • Novartis Investigative Site
      • Las Palmas de Gran Canaria, Spain, 35010
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28031
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Florida
      • Orange Park, Florida, United States, 32073
        • Completed
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33609
        • Withdrawn
        • Novartis Investigative Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Completed
        • Novartis Investigative Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Withdrawn
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Withdrawn
        • Novartis Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Completed
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
Experimental: VAY736
s.c.
Drug: VAY736
s.c.
Placebo Comparator: Placebo to VAY736
Matching placebo (s.c.)
Drug: Placebo to VAY736
s.c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response (HiSCR)
Time Frame: 16 weeks
Proportion of patients achieving clinical response after 16 weeks of treatment
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2019

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

October 23, 2026

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCFZ533H12201BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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