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NCT05513001 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 696
- Enrollment target
- 20
- Study locations
NCT05513001: Active Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
NCT05513001 is a Phase 3 study of Chronic Spontaneous Urticaria that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 696 participants, below the 1,388-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05513001, a Phase 3 study of Chronic Spontaneous Urticaria, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 696 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
Primary Outcome
The efficacy of remibrutinib in CSU participants with a UAS7\<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo. (Epoch 1) Time to first composite event (i.e., relapse (UAS7≥16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LOU064 (blinded)
- DRUG LOU064 (open label)
Study Locations (20)
Florida
- Florida Ctr Allergy Asthma Research - Aventura
- Finlay Medical Research - Greenacres City
- Miami Dade Medical Research - Miami
- Sarasota Clinical Research - Sarasota
- Allergy and Asthma Diagnostic Treatment Center - Tallahassee
California
- Kern Research - Bakersfield
- Antelope Valley Clinical Trials - Lancaster
- Allergy and Asthma Consultants - Redwood City
Alabama
- Allervie Clinical Research - Birmingham
- Cahaba Derm and skin hlth ctr 27 - Birmingham
Arkansas
- Acuro Research Inc - Little Rock
- Arkansas Research Trials - North Little Rock
Colorado
- Asthma and Allergy Associates P C - Colorado Springs
- Colorado Allergy and Asthma Ctr PC - Denver
Illinois
- Endeavor Health - Glenview
- Asthma and Allergy Center of Chicago S C - River Forest
Arizona
- Research Solutions of Arizona - Litchfield Park
Connecticut
- UCONN Health Dermatology - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 696 participants |
| Start Date | 2022-12-09 |
| Est. Completion | 2027-08-02 |
| Phase | Phase 3 |
What the registry record for NCT05513001 still lists
NCT05513001 is an interventional study that assigns participants to a tested intervention. The registered 696 participants enrollment target is mid-sized for trials with a published cap, below the 1,388-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05513001 names 20 study sites across 10 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05513001 about?
NCT05513001 is a clinical study titled "An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib". The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study wil...
What is the current status of trial NCT05513001?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2022-12-09. Estimated completion is 2027-08-02.
What conditions does trial NCT05513001 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT05513001?
The interventions under investigation include: Placebo (DRUG), LOU064 (blinded) (DRUG), LOU064 (open label) (DRUG).
Who is sponsoring clinical trial NCT05513001?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05513001 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05513001's enrollment target sits among peer trials
696 7th of 18 higher than 12 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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