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A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
NCT05976243 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05976243
The ClinicalTrials.gov registry entry for NCT05976243 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05976243 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05976243?
The interventions under investigation include: Placebo (OTHER), Remibrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05976243?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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