An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
Public ClinicalTrials.gov record NCT05513001. 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, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
Study identification
- NCT ID
- NCT05513001
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 696 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 9, 2022 (Actual)
- Primary completion
- Aug 26, 2024 (Actual)
- Completion
- Aug 2, 2027 (Estimated)
- Last update posted
- Mar 11, 2026
2022 – 2027
United States locations
- U.S. sites
- 43
- U.S. states
- 24
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | — |
| Cahaba Derm and skin hlth ctr 27 | Birmingham | Alabama | 35244 | — |
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | — |
| Acuro Research Inc | Little Rock | Arkansas | 72205 | — |
| Arkansas Research Trials | North Little Rock | Arkansas | 72117 | — |
| Kern Research | Bakersfield | California | 93301 | — |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | — |
| Allergy and Asthma Consultants | Redwood City | California | 94063 | — |
| Asthma and Allergy Associates P C | Colorado Springs | Colorado | 80907 | — |
| Colorado Allergy and Asthma Ctr PC | Denver | Colorado | 80230 | — |
| UCONN Health Dermatology | Farmington | Connecticut | 06030-2840 | — |
| Florida Ctr Allergy Asthma Research | Aventura | Florida | 33180 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| Miami Dade Medical Research | Miami | Florida | 33176 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34233 | — |
| Allergy and Asthma Diagnostic Treatment Center | Tallahassee | Florida | 32308 | — |
| Aeroallergy Research Laboratories | Savannah | Georgia | 31406 | — |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | — |
| Endeavor Health | Glenview | Illinois | 60077 | — |
| Asthma and Allergy Center of Chicago S C | River Forest | Illinois | 60305 | — |
| Deaconess Clin Allerg Res Inst | Evansville | Indiana | 47715 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | 42301 | — |
| John Hopkins University | Baltimore | Maryland | 21204 | — |
| Institute for Asthma and Allergy PC | Chevy Chase | Maryland | 20815 | — |
| The Clinical Research Center | St Louis | Missouri | 63141 | — |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | — |
| Allergy Asthma Assoc Monmouth | Little Silver | New Jersey | 07739 | — |
| Oakview Dermatology | Athens | Ohio | 45701 | — |
| CR Services Acquisition US | Columbus | Ohio | 43213 | — |
| Optimed Research LLC | Columbus | Ohio | 43235 | — |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | — |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | 73120 | — |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| National Allergy and Asthma Research LLS | North Charleston | South Carolina | 29420 | — |
| Orion Clinical Research | Austin | Texas | 78759 | — |
| Western Sky Medical Research | El Paso | Texas | 79924 | — |
| RFSA Dermatology | San Antonio | Texas | 78213 | — |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | — |
| Bellingham Asthma Allergy and Immunology | Bellingham | Washington | 98225 | — |
| 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 165 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05513001, 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 Mar 11, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05513001 live on ClinicalTrials.gov.