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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: Completed Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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)).
Primary Outcome
A linear regression with SBP as a covariate was employed. The change in SBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline in the 24-hour weighted average SBP was calculated using the time weighted average of the area under the curve (AUC) of SBP obtained over a 24-hour period as measured by ABPM. That is, the time weighted average of AUC of 24-hour SBP obtained at baseline was subtracted from corresponding time weighted average of AUC of SBP at Week
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 |
What the finished NCT05795153 record still lists
NCT05795153 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,419-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (90% lower).
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 names 20 study sites across 15 states, led by 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.
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 NCT05795153's enrollment target sits among peer trials
144 14th of 18 higher than 5 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
-
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
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Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
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A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
COMPLETED · Phase 3
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