A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Status: Recruiting
Location: See all (161) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

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 ICFs

• Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization

• The following response to the provocation test for each subtype is required at the randomization visit :

‣ Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.

⁃ Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.

⁃ Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.

• Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.

• Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.

• Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period

Locations
United States
Alabama
Allervie Clinical Research
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
Acuro Research Inc
ACTIVE_NOT_RECRUITING
Little Rock
California
Kern Research
ACTIVE_NOT_RECRUITING
Bakersfield
OC Allergy and Asthma Specialists
COMPLETED
Huntington Beach
Antelope Valley Clinical Trials
ACTIVE_NOT_RECRUITING
Lancaster
Colorado
Asthma and Allergy Associates P C
ACTIVE_NOT_RECRUITING
Colorado Springs
Florida
Florida Ctr Allergy Asthma Research
ACTIVE_NOT_RECRUITING
Aventura
Finlay Medical Research
WITHDRAWN
Greenacres City
Sarasota Clinical Research
ACTIVE_NOT_RECRUITING
Sarasota
Univ of South Florida Asthma Allergy and Immunology CRU
ACTIVE_NOT_RECRUITING
Tampa
Georgia
AeroAllergy Research Laboratories of Savannah Inc
COMPLETED
Savannah
Idaho
Treasure Valley Medical Research
ACTIVE_NOT_RECRUITING
Boise
Illinois
Endeavor Health
ACTIVE_NOT_RECRUITING
Glenview
Asthma and Allergy Center of Chicago S C
COMPLETED
River Forest
Indiana
The Indiana Clinical Trials Center
ACTIVE_NOT_RECRUITING
Plainfield
Kentucky
Allergy and Asthma Specialist P S C
ACTIVE_NOT_RECRUITING
Owensboro
Maryland
John Hopkins University
RECRUITING
Baltimore
Nebraska
Somnos Clinical Research
WITHDRAWN
Lincoln
Ohio
Toledo Institute of Clinical Research
WITHDRAWN
Toledo
Oklahoma
Allergy Asthma and Clinical Research
ACTIVE_NOT_RECRUITING
Oklahoma City
Pennsylvania
Allergy and Clinical Immunology Associates
ACTIVE_NOT_RECRUITING
Pittsburgh
South Carolina
National Allergy and Asthma Research LLS
ACTIVE_NOT_RECRUITING
North Charleston
Texas
PanAmerican Clinical Research
ACTIVE_NOT_RECRUITING
Brownsville
Asthma and Allergy Research Assoc
WITHDRAWN
Dallas
Western Sky Medical Research
ACTIVE_NOT_RECRUITING
El Paso
RFSA Dermatology
ACTIVE_NOT_RECRUITING
San Antonio
STAAMP Research LLC
ACTIVE_NOT_RECRUITING
San Antonio
Complete Dermatology
ACTIVE_NOT_RECRUITING
Sugar Land
Utah
Allergy Associates of Utah
ACTIVE_NOT_RECRUITING
Sandy City
Other Locations
Argentina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Buenos Aires
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Rosario
Australia
Novartis Investigative Site
RECRUITING
Carlton
Novartis Investigative Site
RECRUITING
Melbourne
Novartis Investigative Site
RECRUITING
Woolloongabba
Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Alphaville Barueri
Novartis Investigative Site
RECRUITING
Santo André
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sorocaba
Canada
Novartis Investigative Site
RECRUITING
Hamilton
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Trois-rivières
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Winnipeg
China
Novartis Investigative Site
WITHDRAWN
Beijing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Changchun
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Changsha
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chengdu
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chengdu
Novartis Investigative Site
WITHDRAWN
Chongqing
Novartis Investigative Site
COMPLETED
Fuzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangdong
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Jinan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Jinan
Novartis Investigative Site
WITHDRAWN
Nanjing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tianjin
Novartis Investigative Site
COMPLETED
Ürümqi
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuxi
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Yiwu
Colombia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barranquilla
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barranquilla
France
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Grenoble
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Montpellier
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nantes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Paris
Novartis Investigative Site
COMPLETED
Pierre-bénite
Novartis Investigative Site
RECRUITING
Rouen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dresden
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Göttingen
Novartis Investigative Site
WITHDRAWN
Lübeck
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mainz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Münster
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stade
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tübingen
Hong Kong Special Administrative Region
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hong Kong
Hungary
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Debrecen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Debrecen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Szolnok
India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangalore
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mysore
Novartis Investigative Site
RECRUITING
Nagpur
Novartis Investigative Site
RECRUITING
New Delhi
Israel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Haifa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Jerusalem
Novartis Investigative Site
WITHDRAWN
Kfar Saba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ramat Gan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ancona
Novartis Investigative Site
WITHDRAWN
Catania
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Milan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Milan
Novartis Investigative Site
WITHDRAWN
Roma
Novartis Investigative Site
RECRUITING
Rozzano
Japan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bunkyo-ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Habikino
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hiroshima
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Itabashi-ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Izumo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kamimashi-gun
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kitakyushu
Novartis Investigative Site
WITHDRAWN
Kyoto
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ohtsu
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Shimotsuga Gun
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shinjuku Ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tachikawa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Takatsuki
Malaysia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
George Town
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ipoh
Novartis Investigative Site
WITHDRAWN
Kuala Lumpur
Novartis Investigative Site
COMPLETED
Muar Town
Netherlands
Novartis Investigative Site
WITHDRAWN
Groningen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Utrecht
Poland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bydgoszcz
Novartis Investigative Site
WITHDRAWN
Olsztyn
Novartis Investigative Site
WITHDRAWN
Rzeszów
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Warsaw
Portugal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Coimbra
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lisbon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vila Nova De Gaia
Republic of Korea
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seoul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Suwon
Romania
Novartis Investigative Site
WITHDRAWN
Brasov
Novartis Investigative Site
COMPLETED
Bucharest
Novartis Investigative Site
WITHDRAWN
Cluj-napoca
Novartis Investigative Site
WITHDRAWN
Timișoara
Singapore
Novartis Investigative Site
WITHDRAWN
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Kežmarok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Trnava
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Žilina
Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Alicante
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barcelona
Novartis Investigative Site
WITHDRAWN
Córdoba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Granada
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
WITHDRAWN
Móstoles
Novartis Investigative Site
RECRUITING
Santiago De Compostela
Novartis Investigative Site
RECRUITING
Valencia
Thailand
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
COMPLETED
Chiang Mai
Turkey
Novartis Investigative Site
RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sakarya
Novartis Investigative Site
RECRUITING
Talas Kayseri
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Glasgow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Oxford
Viet Nam
Novartis Investigative Site
RECRUITING
Hanoi
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 348
Treatments
Experimental: Remibrutinib, symptomatic dermographism group
Remibrutinib oral twice daily in participants with symptomatic dermographism
Placebo_comparator: Placebo, symptomatic dermographism group
Placebo oral twice daily, symptomatic dermographism
Experimental: Remibrutinib, cold urticaria group
Remibrutinib oral twice daily, cold urticaria
Placebo_comparator: Placebo, cold urticaria group
Placebo oral twice daily, cold urticaria
Experimental: Remibrutinib, cholinergic urticaria group
Remibrutinib oral twice daily, cholinergic urticaria
Placebo_comparator: Placebo, cholinergic urticaria
Placebo oral twice daily, cholinergic urticaria
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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