A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Status: Recruiting
Location: See all (117) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Male and female participants ≥ 18 years of age at the time of signing of the informed consent.

• Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.

• Participants with moderate to severe HS defined as:

‣ A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND

⁃ Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)

Locations
United States
Alabama
Total Skin and Beauty Dermatology Center PC
RECRUITING
Birmingham
Arizona
CTT Research
RECRUITING
Gilbert
Ctr Dermatology and Plastic Surgery
RECRUITING
Scottsdale
California
Ctr for Dermatology Clinical Res
RECRUITING
Fremont
USC Keck School of Medicine
RECRUITING
Los Angeles
MedDerm Associates
RECRUITING
San Diego
Florida
Driven Research
RECRUITING
Coral Gables
Floridian Research Institute
RECRUITING
Miami
Sarasota Arthritis Res Ctr
RECRUITING
Sarasota
University Of South Florida
RECRUITING
Tampa
Georgia
Atlanta Biomedical Clin Res LLC
RECRUITING
Atlanta
Emory School of Med Dermatology
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Endeavor Health
RECRUITING
Glenview
Dundee Dermatology
RECRUITING
West Dundee
Indiana
Southern IN Clinical Trials
RECRUITING
New Albany
Massachusetts
Beth Israel Deaconess Med Center
RECRUITING
Boston
Metro Boston Clinical Partners
RECRUITING
Brighton
Michigan
Clinical Research Inst of MI
RECRUITING
Chesterfield
Missouri
Deluxe Dermatology
RECRUITING
St Louis
Nebraska
Skin Specialists PC
RECRUITING
Omaha
Nevada
Vivida Dermatology
RECRUITING
Las Vegas
New York
North Shore University Hospital
RECRUITING
New Hyde Park
Cameron Dermatology
RECRUITING
New York
Ohio
Optima Research Boardman
RECRUITING
Boardman
Ohio State University
RECRUITING
Columbus
Wright State University
RECRUITING
Fairborn
Apex Clinical Research Center LLC
RECRUITING
Mayfield Heights
South Carolina
Clinical Research Ctr of Carolinas
RECRUITING
Charleston
Tennessee
Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Texas
Accurate Clinical Research
RECRUITING
Humble
Austin Inst for Clinical Research
RECRUITING
Pflugerville
Center for Clinical Studies-Lee
RECRUITING
Webster
Virginia
Care Access Alexandria
RECRUITING
Arlington
Complexions Dermatology
RECRUITING
Danville
Forefront Dermatology
RECRUITING
Vienna
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Córdoba
Austria
Novartis Investigative Site
RECRUITING
Linz
Belgium
Novartis Investigative Site
RECRUITING
Brussels
Novartis Investigative Site
RECRUITING
Leuven
Novartis Investigative Site
RECRUITING
Liège
Novartis Investigative Site
RECRUITING
Woluwe-saint-lambert
Canada
Novartis Investigative Site
RECRUITING
Edmonton
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Québec
Novartis Investigative Site
RECRUITING
Sherbrooke
Colombia
Novartis Investigative Site
RECRUITING
Bogota
Novartis Investigative Site
RECRUITING
Bogota
Novartis Investigative Site
RECRUITING
Medellín
Novartis Investigative Site
RECRUITING
Medellín
France
Novartis Investigative Site
RECRUITING
Brest
Novartis Investigative Site
RECRUITING
La Rochelle
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Nice
Novartis Investigative Site
RECRUITING
Reims
Novartis Investigative Site
RECRUITING
Rouen
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Bad Bentheim
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Dessau
Novartis Investigative Site
RECRUITING
Dortmund
Novartis Investigative Site
RECRUITING
Düsseldorf
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Leipzig
Novartis Investigative Site
RECRUITING
Lübeck
Novartis Investigative Site
RECRUITING
Merzig
Novartis Investigative Site
RECRUITING
Minden
Novartis Investigative Site
RECRUITING
München
Novartis Investigative Site
RECRUITING
Tübingen
Novartis Investigative Site
RECRUITING
Würzburg
Greece
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Thessaloniki
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Debrecen
Novartis Investigative Site
RECRUITING
Kecskemét
Novartis Investigative Site
RECRUITING
Pécs
Novartis Investigative Site
RECRUITING
Szeged
Malaysia
Novartis Investigative Site
RECRUITING
Ipoh
Novartis Investigative Site
RECRUITING
Johor Bahru
Novartis Investigative Site
RECRUITING
Kota Kinabalu
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Selangor Darul Ehsan
Novartis Investigative Site
RECRUITING
Wilayah Persekutuan
Poland
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Warsaw
Puerto Rico
Alma Cruz-Santana Private Practice
RECRUITING
Carolina
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Bucharest
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Granada
Novartis Investigative Site
RECRUITING
Granollers
Novartis Investigative Site
RECRUITING
Las Palmas Gc
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Palma
Novartis Investigative Site
RECRUITING
Pontevedra
Novartis Investigative Site
RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Aydin
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Mersin
Novartis Investigative Site
RECRUITING
Üsküdar
United Kingdom
Novartis Investigative Site
RECRUITING
Cardiff
Novartis Investigative Site
RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2028-10-20
Participants
Target number of participants: 555
Treatments
Experimental: Remibrutinib Dose A (Treatment Period 1 and 2)
articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2
Experimental: Remibrutinib Dose B (Treatment Period 1 and 2)
Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2
Placebo_comparator: Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)
Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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