A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Condition(s) studied
Investigational drug(s) / intervention(s)
Remibrutinib: Remibrutinib treated groups and arms
Placebo: Placebo treated groups and arms
Study 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
Primary outcome measure(s)
- Proportion of participants with complete response in Total Fric Score; symptomatic dermographism — Week 12
Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1) - Proportion of participants with complete response in critical temperature threshold; cold urticaria — Week 12
The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms. - Proportion of participants with itch numerical rating scale =0; cholinergic urticaria — Week 12
Itch numerical rating scale, a scale from 0 to 10 Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")
Trial sites (130)
| Facility | City | Region | Status |
|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | |
| Acuro Research Inc | Little Rock | Arkansas | |
| Kern Research | Bakersfield | California | |
| Allergy and Asthma Specialists Group | Huntington Beach | California | |
| Antelope Valley Clinical Trials | Lancaster | California | |
| Asthma and Allergy Associates P C | Colorado Springs | Colorado | |
| Florida Ctr Allergy Asthma Research | Aventura | Florida | |
| Sarasota Clinical Research | Sarasota | Florida | |
| Univ of South Florida Asthma Allergy and Immunology CRU | Tampa | Florida | |
| Aeroallergy Research Laboratories | Savannah | Georgia | |
| Treasure Valley Medical Research | Boise | Idaho | |
| Endeavor Health | Glenview | Illinois | |
| Asthma and Allergy Center of Chicago S C | River Forest | Illinois | |
| The Indiana Clinical Trials Center | Plainfield | Indiana | |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | |
| John Hopkins University | Baltimore | Maryland | |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | |
| National Allergy and Asthma Research LLS | North Charleston | South Carolina | |
| PanAmerican Clinical Research | Brownsville | Texas | |
| Western Sky Medical Research | El Paso | Texas | |
| RFSA Dermatology | San Antonio | Texas | |
| STAAMP Research LLC | San Antonio | Texas | |
| Complete Dermatology | Sugarland | Texas | |
| Allergy Associates of Utah | Sandy City | Utah | |
| Novartis Investigative Site | Caba | Buenos Aires | |
| Novartis Investigative Site | CABA | Buenos Aires | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | Woolloongabba | Queensland | |
| Novartis Investigative Site | Carlton | Victoria | |
| Novartis Investigative Site | Melbourne | Victoria | |
| Novartis Investigative Site | Alphaville Barueri | São Paulo | |
| Novartis Investigative Site | Santo André | São Paulo | |
| Novartis Investigative Site | Sorocaba | São Paulo | |
| Novartis Investigative Site | Winnipeg | Manitoba | |
| Novartis Investigative Site | Hamilton | Ontario | |
| Novartis Investigative Site | Trois-Rivières | Quebec | |
| Novartis Investigative Site | Fuzhou | Fujian | |
| Novartis Investigative Site | Guangzhou | Guangdong |
+ 90 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05976243 on ClinicalTrials.gov ↗ ← All trials in Turkey