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NCT05030311 · 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
- 470
- Enrollment target
NCT05030311: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT05030311 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 470 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030311, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 470 participants
- Enrollment target
Study Summary
The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines 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 25 mg (b.i.d)
- DRUG LOU064 25 mg (b.i.d) as a tablet.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 3 |
What the finished NCT05030311 record still lists
NCT05030311 is an interventional study that assigns participants to a tested intervention. The registered 470 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 (39% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05030311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05030311 about?
NCT05030311 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 (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.
What is the current status of trial NCT05030311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 470 participants. The study started on 2021-11-30. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT05030311?
The interventions under investigation include: Placebo (DRUG), LOU064 25 mg (b.i.d) (DRUG), LOU064 25 mg (b.i.d) as a tablet. (DRUG).
Who is sponsoring clinical trial NCT05030311?
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 NCT05030311's enrollment target sits among peer trials
470 813th of 2000 higher than 1,186 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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