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NCT05795153 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT05795153 is a Phase 3 study of Chronic Spontaneous Urticaria that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 144 participants, below the 1,419-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05795153, a Phase 3 study of Chronic Spontaneous Urticaria, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety and efficacy over 12 weeks in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled with second generation H1 antihistamines (H1-AH) treatment. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).
Conditions Studied
Interventions
- DRUG LOU064
Study Locations (20)
Other
- Novartis Investigative Site - Angers
- Novartis Investigative Site - Antony
- Novartis Investigative Site - Brest
- Novartis Investigative Site - Montpellier
Florida
- Florida Ctr Allergy Asthma Research - Aventura
- Finlay Medical Research - Greenacres City
Buenos Aires
- Novartis Investigative Site - Nueve de Julio
- Novartis Investigative Site - Sourigues
Arkansas
- Acuro Research Inc - Little Rock
Idaho
- Treasure Valley Medical Research - Boise
Illinois
- Endeavor Health - Glenview
Kentucky
- Allergy and Asthma Specialist P S C - Owensboro
Oklahoma
- Allergy Asthma and Clinical Research - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05795153
The ClinicalTrials.gov registry entry for NCT05795153 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,419-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (90% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention - of which LOU064 is the first listed.
NCT05795153 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Florida, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT05795153 about?
NCT05795153 is a clinical study titled "A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.". The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety ...
What is the current status of trial NCT05795153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2023-04-05. Estimated completion is 2024-04-25.
What conditions does trial NCT05795153 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT05795153?
The interventions under investigation include: LOU064 (DRUG).
Who is sponsoring clinical trial NCT05795153?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05795153 being conducted?
This trial has 20 study locations across Arkansas, Florida, Idaho, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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