A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05976243
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Inducible Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Remibrutinib — DRUG
    Remibrutinib treated groups and arms
  • Placebo — OTHER
    Placebo treated groups and arms

Study Details

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

Key Dates

Start date
Dec 7, 2023
Status verified
Jun 2026
Primary completion
May 11, 2026
Completion
Jun 15, 2029

Study Design

Enrollment
362 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Proportion of participants with complete response in Total Fric Score; symptomatic dermographism [ Time Frame: Week 12 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Allervie Clinical ResearchBirminghamAlabama35209-
Acuro Research IncLittle RockArkansas72205-
Kern ResearchBakersfieldCalifornia93301-
Allergy and Asthma Specialists GroupHuntington BeachCalifornia92647-
Antelope Valley Clinical TrialsLancasterCalifornia93534-
Asthma and Allergy Associates P CColorado SpringsColorado80907-
Florida Ctr Allergy Asthma ResearchAventuraFlorida33180-
Sarasota Clinical ResearchSarasotaFlorida34233-
Univ of South Florida Asthma Allergy and Immunology CRUTampaFlorida33613-
Aeroallergy Research LaboratoriesSavannahGeorgia31406-
Treasure Valley Medical ResearchBoiseIdaho83706-
Endeavor HealthGlenviewIllinois60077-
Asthma and Allergy Center of Chicago S CRiver ForestIllinois60305-
The Indiana Clinical Trials CenterPlainfieldIndiana46168-
Allergy and Asthma Specialist P S COwensboroKentucky42301-
John Hopkins UniversityBaltimoreMaryland21204-
Allergy Asthma and Clinical ResearchOklahoma CityOklahoma73120-
Allergy and Clinical Immunology AssociatesPittsburghPennsylvania15241-
National Allergy and Asthma Research LLSNorth CharlestonSouth Carolina29420-
PanAmerican Clinical ResearchBrownsvilleTexas78520-
Western Sky Medical ResearchEl PasoTexas79924-
RFSA DermatologySan AntonioTexas78213-
STAAMP Research LLCSan AntonioTexas78229-
Complete DermatologySugar LandTexas77479-
Allergy Associates of UtahSandy CityUtah84093-

Find similar trials in Birmingham, AL

By research site
Allervie Clinical Research· Birmingham, ALAcuro Research Inc· Little Rock, ARKern Research· Bakersfield, CAAllergy and Asthma Specialists Group· Huntington Beach, CAAntelope Valley Clinical Trials· Lancaster, CAAsthma and Allergy Associates P C· Colorado Springs, CO

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