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NCT05677451 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05677451: Recruiting Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
NCT05677451 is a Phase 3 study of Chronic Spontaneous Urticaria that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 100 participants, below the 1,422-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05677451, a Phase 3 study of Chronic Spontaneous Urticaria, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
Primary Outcome
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Negative change from baseline indicates improvement.
Conditions Studied
Interventions
- DRUG placebo
- DRUG LOU064 (blinded)
Study Locations (20)
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - CABA
- Novartis Investigative Site - CABA
California
- Kern Research - Bakersfield
- Allergy and Asthma Medical Group and Research Center - San Diego
Florida
- Pediatric Dermatology of Miami at the Pediatric CoE - Coral Gables
Idaho
- Treasure Valley Medical Research - Boise
Illinois
- Endeavor Health - Glenview
Kentucky
- Allergy and Asthma Specialist P S C - Owensboro
Ohio
- Toledo Institute of Clinical Research - Toledo
Oklahoma
- Allergy Asthma and Clinical Research - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2032-03-30 |
| Phase | Phase 3 |
What NCT05677451 shows while recruiting
NCT05677451 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,422-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT05677451 names 20 study sites across 17 states, led by Buenos Aires, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05677451 about?
NCT05677451 is a clinical study titled "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". The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and toler...
What is the current status of trial NCT05677451?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-07-11. Estimated completion is 2032-03-30.
What conditions does trial NCT05677451 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT05677451?
The interventions under investigation include: placebo (DRUG), LOU064 (blinded) (DRUG).
Who is sponsoring clinical trial NCT05677451?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05677451 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05677451's enrollment target sits among peer trials
100 16th of 18 higher than 3 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
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COMPLETED · Phase 3
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