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NCT05032157 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT05032157: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT05032157 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05032157, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.
Primary Outcome
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0
Interventions
- DRUG Placebo
- DRUG LOU064 (blinded)
- DRUG LOU064 (open-label)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2024-01-05 |
| Phase | Phase 3 |
What the finished NCT05032157 record still lists
NCT05032157 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05032157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05032157 about?
NCT05032157 is a clinical study titled "A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines". The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.
What is the current status of trial NCT05032157?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2021-12-01. Estimated completion is 2024-01-05.
What interventions are being tested in trial NCT05032157?
The interventions under investigation include: Placebo (DRUG), LOU064 (blinded) (DRUG), LOU064 (open-label) (DRUG).
Who is sponsoring clinical trial NCT05032157?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05032157's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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