A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Public ClinicalTrials.gov record NCT05976243. 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 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
Study identification
- NCT ID
- NCT05976243
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 362 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 6, 2023
- Primary completion
- May 10, 2026
- Completion
- Jun 14, 2029
- Last update posted
- Aug 19, 2026
2023 – 2029
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | — |
| Acuro Research Inc | Little Rock | Arkansas | 72205 | — |
| Kern Research | Bakersfield | California | 93301 | — |
| Allergy and Asthma Specialists Group | Huntington Beach | California | 92647 | — |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | — |
| Asthma and Allergy Associates P C | Colorado Springs | Colorado | 80907 | — |
| Florida Ctr Allergy Asthma Research | Aventura | Florida | 33180 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34233 | — |
| Univ of South Florida Asthma Allergy and Immunology CRU | Tampa | Florida | 33613 | — |
| 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 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | 42301 | — |
| John Hopkins University | Baltimore | Maryland | 21204 | — |
| 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 | — |
| PanAmerican Clinical Research | Brownsville | Texas | 78520 | — |
| Western Sky Medical Research | El Paso | Texas | 79924 | — |
| RFSA Dermatology | San Antonio | Texas | 78213 | — |
| STAAMP Research LLC | San Antonio | Texas | 78229 | — |
| Complete Dermatology | Sugarland | Texas | 77479 | — |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | — |
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 105 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05976243, 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 Aug 19, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05976243 live on ClinicalTrials.gov.