WHO ICTRP trial
A Phase 3 study of efficacy and safety of remibrutinib in the treatment of…
EUCTR2021-000424-35-SK · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2021-000424-35-SK |
|---|---|
| Public title | A Phase 3 study of efficacy and safety of remibrutinib in the treatment of chronic spontaneous urticaria in adults inadequately controlled by H1-antihistamines |
| Scientific title | A multicenter, randomized, double-blind, placebo-controlled Phase 3 study of remibrutinib (LOU064) to investigate the efficacy, safety and tolerability for 52 weeks in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines. - REMIX-2 |
| Primary sponsor | Novartis Pharma AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Russian Federation;Viet Nam;United States;United Kingdom;Malaysia;Thailand;Switzerland;India;Canada;Austria;China;Taiwan;Brazil;Denmark;Poland;South Africa;Slovakia;Germany |
| Conditions | Chronic Spontaneous Urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and… |
| Interventions | Product Name: Remibrutinib Product Code: LOU064 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Remibrutinib Current Sponsor code: LOU064 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25… |
| Registration date | Aug 26, 2021 |
| Target size | 450 |
| Secondary IDs | CLOU064A2302 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: