24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Public ClinicalTrials.gov record NCT05677451. 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 Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Study identification
- NCT ID
- NCT05677451
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- LOU064 (blinded) Drug
- placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 17 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
- Jul 10, 2023
- Primary completion
- Nov 5, 2026
- Completion
- Mar 29, 2032
- Last update posted
- May 4, 2026
2023 – 2032
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kern Research | Bakersfield | California | 93301 | Recruiting |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | 92123 | Recruiting |
| Pediatric Dermatology of Miami at the Pediatric CoE | Miami | Florida | 33156 | Recruiting |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | Active, not recruiting |
| Endeavor Health | Glenview | Illinois | 60077 | Active, not recruiting |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | 42301 | Recruiting |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | Recruiting |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | 73120 | Recruiting |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | Active, not recruiting |
| RFSA Dermatology | San Antonio | Texas | 78213 | Recruiting |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | Completed |
| Seattle Allergy and Asthma Rsch | Seattle | Washington | 98115 | Withdrawn |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05677451, 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 May 4, 2026 · Synced May 19, 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 protocol, eligibility criteria, and contact information for NCT05677451 live on ClinicalTrials.gov.