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

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ClinicalTrials.gov Identifier: NCT03827798
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 7, 2019
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 and LYS006 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533 and LYS006 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : June 17, 2020
Estimated Study Completion Date : May 10, 2021

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.




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

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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
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Novartis Investigative Site Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03827798     History of Changes
Other Study ID Numbers: CCFZ533H12201BC
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
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


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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

Additional relevant MeSH terms:
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Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration