A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
Public ClinicalTrials.gov record NCT05030311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05030311
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 470 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2021 (Actual)
- Primary completion
- Dec 27, 2023 (Actual)
- Completion
- Jan 19, 2024 (Actual)
- Last update posted
- Apr 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | — |
| Novartis Investigative Site | North Little Rock | Arkansas | 72117 | — |
| Novartis Investigative Site | Bakersfield | California | 93301 | — |
| Novartis Investigative Site | Lancaster | California | 93534 | — |
| Novartis Investigative Site | Los Angeles | California | 90025 | — |
| Novartis Investigative Site | Redwood City | California | 94063 | — |
| Novartis Investigative Site | Denver | Colorado | 80230 | — |
| Novartis Investigative Site | Aventura | Florida | 33180 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| Novartis Investigative Site | Sarasota | Florida | 34233 | — |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | — |
| Novartis Investigative Site | Albany | Georgia | 31707 | — |
| Novartis Investigative Site | Woodstock | Georgia | 30188 | — |
| Novartis Investigative Site | Evansville | Indiana | 47715 | — |
| Novartis Investigative Site | Chevy Chase | Maryland | 20815 | — |
| Novartis Investigative Site | St Louis | Missouri | 63141 | — |
| Novartis Investigative Site | Lincoln | Nebraska | 68510 | — |
| Novartis Investigative Site | Athens | Ohio | 45701 | — |
| Novartis Investigative Site | Columbus | Ohio | 43235 | — |
| Novartis Investigative Site | Toledo | Ohio | 43617 | — |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | — |
| Novartis Investigative Site | Austin | Texas | 78759 | — |
| Novartis Investigative Site | El Paso | Texas | 79924 | — |
| Novartis Investigative Site | San Antonio | Texas | 78213 | — |
| Novartis Investigative Site | Sandy City | Utah | 84093 | — |
| Novartis Investigative Site | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05030311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2025 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05030311 live on ClinicalTrials.gov.