ACTIVE_NOT_RECRUITING

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

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Conditions

Chronic Inducible UrticariaCINDUBTKremibrutinibsymptomatic dermographsimcold urticariacholinergic urticaria

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-12-07
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05976243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Allervie Clinical Research
Birmingham, Alabama, 35209
United States
Acuro Research Inc
Little Rock, Arkansas, 72205
United States
Kern Research
Bakersfield, California, 93301
United States
Allergy and Asthma Specialists Group
Huntington Beach, California, 92647
United States
Antelope Valley Clinical Trials
Lancaster, California, 93534
United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, 80907
United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, 33180
United States
Sarasota Clinical Research
Sarasota, Florida, 34233
United States
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida, 33613
United States
Aeroallergy Research Laboratories
Savannah, Georgia, 31406
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
Endeavor Health
Glenview, Illinois, 60077
United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, 60305
United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, 42301
United States
John Hopkins University
Baltimore, Maryland, 21204
United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, 73120
United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, 29420
United States
PanAmerican Clinical Research
Brownsville, Texas, 78520
United States
Western Sky Medical Research
El Paso, Texas, 79924
United States
RFSA Dermatology
San Antonio, Texas, 78213
United States
STAAMP Research LLC
San Antonio, Texas, 78229
United States
Complete Dermatology
Sugar Land, Texas, 77479
United States
Allergy Associates of Utah
Sandy City, Utah, 84093
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2023-12-07
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • CINDU
  • Chronic inducible urticaria
  • BTK
  • remibrutinib
  • symptomatic dermographsim
  • cold urticaria
  • cholinergic urticaria

Additional Relevant MeSH Terms

  • Chronic Inducible Urticaria