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ClinicalTrials.gov public records Last synced Sep 15, 2026, 11:14 PM EDT

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Showing 1–3 of 3 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LOU064 Arm 2 Clear all
Active, not recruiting Phase 3 Interventional

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

NCT05677451
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 (blinded), placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 17 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2032
U.S. locations
11
States / cities
Bakersfield, California • San Diego, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Sep 15, 2026, 11:14 PM EDT
Active, not recruiting Phase 3 Interventional

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

NCT05513001
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 (blinded), Placebo, LOU064 (open label)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
696 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
43
States / cities
Birmingham, Alabama • Litchfield Park, Arizona • Little Rock, Arkansas + 38 more
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 15, 2026, 11:14 PM EDT
Completed Phase 2 Interventional Results available

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

NCT03926611
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 Arm 1, LOU064 Arm 2, LOU064 Arm 3, LOU064 Arm 4, LOU064 Arm 5, LOU064 Arm 6, Placebo arm
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
311 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
11
States / cities
Litchfield Park, Arizona • Little Rock, Arkansas • Mission Viejo, California + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2022 · Synced Sep 15, 2026, 11:14 PM EDT