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NCT05976243 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
A Phase 3 study of Chronic Inducible Urticaria, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 362
- Enrollment target
- 20
- Study locations
NCT05976243: Active Phase 3 study of Chronic Inducible Urticaria, sponsored by Novartis Pharmaceuticals.
NCT05976243 is a Phase 3 study of Chronic Inducible Urticaria that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 362 participants, above the 144-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05976243, a Phase 3 study of Chronic Inducible Urticaria, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 362 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Remibrutinib
Study Locations (20)
California
- Kern Research - Bakersfield
- Allergy and Asthma Specialists Group - Huntington Beach
- Antelope Valley Clinical Trials - Lancaster
Florida
- Florida Ctr Allergy Asthma Research - Aventura
- Sarasota Clinical Research - Sarasota
- Univ of South Florida Asthma Allergy and Immunology CRU - Tampa
Illinois
- Endeavor Health - Glenview
- Asthma and Allergy Center of Chicago S C - River Forest
Alabama
- Allervie Clinical Research - Birmingham
Arkansas
- Acuro Research Inc - Little Rock
Colorado
- Asthma and Allergy Associates P C - Colorado Springs
Georgia
- Aeroallergy Research Laboratories - Savannah
Idaho
- Treasure Valley Medical Research - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2023-12-07 |
| Est. Completion | 2029-06-15 |
| Phase | Phase 3 |
What the registry record for NCT05976243 still lists
NCT05976243 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, above the 144-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target (151% higher).
The record links to 1 condition, with Chronic Inducible Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05976243 names 20 study sites across 15 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05976243 about?
NCT05976243 is a clinical study titled "A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines". 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 (LO...
What is the current status of trial NCT05976243?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2023-12-07. Estimated completion is 2029-06-15.
What conditions does trial NCT05976243 study?
This clinical trial studies the following conditions: Chronic Inducible Urticaria.
What interventions are being tested in trial NCT05976243?
The interventions under investigation include: Placebo (OTHER), Remibrutinib (DRUG).
Who is sponsoring clinical trial NCT05976243?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05976243 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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