MedPath

Remibrutinib

Generic Name
Remibrutinib
Drug Type
Small Molecule
Chemical Formula
C27H27F2N5O3
CAS Number
1787294-07-8
Unique Ingredient Identifier
I7MVZ8HDNU

A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

Phase 3
Completed
Conditions
Chronic Spontaneous Urticaria
Interventions
First Posted Date
2021-09-17
Last Posted Date
2025-04-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
71
Registration Number
NCT05048342
Locations
🇯🇵

Novartis Investigative Site, Osaka, Japan

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Phase 2
Completed
Conditions
Chronic Spontaneous Urticaria
Interventions
First Posted Date
2019-09-30
Last Posted Date
2024-06-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
229
Registration Number
NCT04109313
Locations
🇬🇧

Novartis Investigative Site, Plymouth, United Kingdom

A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

Phase 2
Terminated
Conditions
Sjögren Syndrome
Interventions
Drug: Placebo
First Posted Date
2019-07-29
Last Posted Date
2023-01-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
73
Registration Number
NCT04035668
Locations
🇬🇧

Novartis Investigative Site, Tyne And Wear, United Kingdom

Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064

Phase 1
Completed
Conditions
Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis
Interventions
Drug: Placebo
First Posted Date
2019-04-18
Last Posted Date
2021-10-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
185
Registration Number
NCT03918980
Locations
🇳🇱

Novartis Investigative Site, Leiden, Netherlands

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