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 (135) 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
Arkansas
Johnson Dermatology
RECRUITING
Fort Smith
Arkansas Research Trials
RECRUITING
North Little Rock
Arizona
Medical Dermatology Specialists
RECRUITING
Phoenix
California
Cheryl Effron MD Inc
RECRUITING
Anaheim
Physioseq
RECRUITING
Sacramento
Olive View UCLA Medical Center
RECRUITING
Sylmar
Clinical Trials Research Institute
RECRUITING
Thousand Oaks
Washington, D.c.
Howard University College of Medicine
RECRUITING
Washington D.c.
Florida
Florida Academic Centers Research and Education LLC
RECRUITING
Coral Gables
University of MiamiHealth System
RECRUITING
Miami
Ziaderm Research LLC
RECRUITING
North Miami Beach
Georgia
Revival Research Institute LLC
RECRUITING
Evans
Gwinnett Clinical Research Center
RECRUITING
Snellville
Immunology-Rheumatology Research
WITHDRAWN
Suwanee
Illinois
Illinois Dermatology Institute
RECRUITING
Chicago
Indiana
Dawes Fretzin Clinical Rea Group
RECRUITING
Indianapolis
Kentucky
Equity Medical LLC
RECRUITING
Bowling Green
Louisiana
Dermat. and Adv. Aesthetics
RECRUITING
Lake Charles
Michigan
Michigan Center for Rsrch Company
RECRUITING
Clarkston
Henry Ford Hospital
RECRUITING
Detroit
Revival Research Institute
RECRUITING
Troy
Mississippi
University of Mississippi Med Ctr
RECRUITING
Jackson
North Carolina
OnSite Clinical Solutions LLC
RECRUITING
Huntersville
Wake Forest Baptist Health
RECRUITING
Winston-salem
New Jersey
Care Access Hoboken
RECRUITING
Hoboken
New York
Forest Hills Dermatology Group
RECRUITING
New York
Icahn School Of Med At Mount Sinai
RECRUITING
New York
Skinsearch of Rochester Inc
RECRUITING
Rochester
Oklahoma
Unity Clinical Research
RECRUITING
Oklahoma City
Essential Medical Research
RECRUITING
Tulsa
Pennsylvania
UP Medical Center H System
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina MUSC
RECRUITING
Charleston
Tennessee
Advanced Research Experts
RECRUITING
Nashville
Texas
Bellaire Dermatology Associates
RECRUITING
Bellaire
RFSA Dermatology
RECRUITING
San Antonio
Virginia
Virginia Clinical Research
RECRUITING
Norfolk
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Santa Fe
Australia
Novartis Investigative Site
RECRUITING
Darlinghurst
Novartis Investigative Site
RECRUITING
Melbourne
Novartis Investigative Site
RECRUITING
Parkville
Novartis Investigative Site
RECRUITING
Phillip
Novartis Investigative Site
RECRUITING
Westmead
Bulgaria
Novartis Investigative Site
RECRUITING
Pleven
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Stara Zagora
Canada
Novartis Investigative Site
RECRUITING
Hamilton
Novartis Investigative Site
RECRUITING
Québec
Novartis Investigative Site
RECRUITING
Richmond Hill
Novartis Investigative Site
RECRUITING
Saint-jérôme
Novartis Investigative Site
RECRUITING
St. John's
Novartis Investigative Site
RECRUITING
Surrey
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Changsha
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Fuzhou
Novartis Investigative Site
RECRUITING
Jinan
Novartis Investigative Site
RECRUITING
Shenyang
Novartis Investigative Site
RECRUITING
Ürümqi
Novartis Investigative Site
RECRUITING
Wuhan
Novartis Investigative Site
RECRUITING
Xian
Novartis Investigative Site
RECRUITING
Zhejiang
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Medellín
Denmark
Novartis Investigative Site
RECRUITING
Kobenhavn N V
Novartis Investigative Site
RECRUITING
Roskilde
Germany
Novartis Investigative Site
RECRUITING
Aachen
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Bochum
Novartis Investigative Site
RECRUITING
Bonn
Novartis Investigative Site
RECRUITING
Darmstadt
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Erlangen
Novartis Investigative Site
RECRUITING
Halle
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Hanover
Novartis Investigative Site
RECRUITING
Kiel
Novartis Investigative Site
RECRUITING
Langenau
Novartis Investigative Site
RECRUITING
Mainz
Novartis Investigative Site
RECRUITING
Münster
Greece
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Heraklion Crete.
Novartis Investigative Site
RECRUITING
Thessaloniki
Italy
Novartis Investigative Site
RECRUITING
Ancona
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Cona
Novartis Investigative Site
RECRUITING
Florence
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Pisa
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Rozzano
Novartis Investigative Site
RECRUITING
Torino
Malaysia
Novartis Investigative Site
RECRUITING
George Town
Novartis Investigative Site
RECRUITING
Kota Bharu
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Kuala Terengganu
Novartis Investigative Site
RECRUITING
Kuching
Novartis Investigative Site
RECRUITING
Muar Town
Mexico
Novartis Investigative Site
RECRUITING
Chihuahua City
Novartis Investigative Site
RECRUITING
Cuauhtémoc
Novartis Investigative Site
RECRUITING
Guadalajara
Novartis Investigative Site
RECRUITING
Guadalajara
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Gdansk
Novartis Investigative Site
RECRUITING
Warsaw
Portugal
Novartis Investigative Site
RECRUITING
Almada
Novartis Investigative Site
RECRUITING
Braga
Novartis Investigative Site
RECRUITING
Lisbon
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Prešov
Novartis Investigative Site
RECRUITING
Trnava
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Durban
Novartis Investigative Site
RECRUITING
Raslouw Centurion
Novartis Investigative Site
RECRUITING
Soweto
Spain
Novartis Investigative Site
RECRUITING
Badalona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Cadiz
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Manises
Novartis Investigative Site
RECRUITING
Sabadell
Novartis Investigative Site
RECRUITING
Valencia
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Basel
Novartis Investigative Site
RECRUITING
Bern
Novartis Investigative Site
RECRUITING
Zurich
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
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: 2025-01-31
Estimated Completion Date: 2028-10-20
Participants
Target number of participants: 555
Treatments
Experimental: Remibrutinib Dose A (Treatment Period 1 and 2)
Participants 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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