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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 455 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05032157
The ClinicalTrials.gov registry entry for NCT05032157 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 455 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.
NCT05032157 reports 0 study locations.
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.
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