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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) 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.

Key facts

Study ID

NCT03827798

Run by

Novartis Pharmaceuticals

People needed

248

Starts

2019-02-27

Expected to finish

2026-12-11

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Olympian Clinical Research — Clearwater, Florida, United States
• Park Avenue Dermatology PA — Orange Park, Florida, United States
• University Of South Florida — Tampa, Florida, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina MUSC — Charleston, South Carolina, United States
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Prague, Prague 1, Czechia
• Novartis Investigative Site — Copenhagen, Denmark
• Novartis Investigative Site — Roskilde, Denmark
• Novartis Investigative Site — Antony, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Reims, France
• Novartis Investigative Site — Rouen, France
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Schwerin, Germany
• Novartis Investigative Site — Pécs, Baranya, Hungary
• Novartis Investigative Site — Debrecen, Hajdu Bihar Megye, Hungary

Full record on ClinicalTrials.gov

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