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 NCT05032157. 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 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.
Study identification
- NCT ID
- NCT05032157
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 455 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- 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
- Dec 1, 2021 (Actual)
- Primary completion
- Dec 18, 2023 (Actual)
- Completion
- Jan 5, 2024 (Actual)
- Last update posted
- Apr 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 30
- U.S. states
- 24
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Derm and skin hlth ctr 27 | Birmingham | Alabama | 35244 | — |
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | — |
| Little Rock Allergy and Asthma Clnc | Little Rock | Arkansas | 72205 | — |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | 92123 | — |
| UCONN Health Dermatology | Farmington | Connecticut | 06030-2840 | — |
| Miami Dade Medical Research | Miami | Florida | 33176 | — |
| Ziaderm Research LLC | North Miami Beach | Florida | 33162 | — |
| Riverchase Dermatology | Pembroke Pines | Florida | 33028 | — |
| TrueBlue Clinical Research | Tampa | Florida | 33609 | — |
| AeroAllergy Research Laboratories of Savannah Inc | Savannah | Georgia | 31406 | — |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | — |
| Northshore University Health System | Glenview | Illinois | 60077 | — |
| Asthma and Allergy Center of Chicago S C | River Forest | Illinois | 60305 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | 42301 | — |
| John Hopkins University | Baltimore | Maryland | 21204 | — |
| Chesapeake Clinical Research | White Marsh | Maryland | 21162 | — |
| Revival Research Institute | Troy | Michigan | 48084 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| Allergy Asthma Assoc Monmouth | Little Silver | New Jersey | 07739 | — |
| Peters Medical Research | High Point | North Carolina | 27260 | — |
| CR Services Acquisition US | Dublin | Ohio | 43016 | — |
| Ohio Clinical Research Associates | Mayfield Heights | Ohio | 44124 | — |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | 73120 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| National Allergy and Asthma Research LLS | North Charleston | South Carolina | 29420 | — |
| STAAMP Research LLC | San Antonio | Texas | 78229 | — |
| Intermountain Clinical Research | Salt Lake City | Utah | 84102 | — |
| Seattle Allergy and Asthma Rsch | Seattle | Washington | 98115 | — |
| Allergy Asthma and amp Sinus Ctr S C | Greenfield | Wisconsin | 53228 | — |
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 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05032157, 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 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05032157 live on ClinicalTrials.gov.