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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 470 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05030311
The ClinicalTrials.gov registry entry for NCT05030311 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 470 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05030311 reports 0 study locations.
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.
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