Last updated 26 days ago

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

800 patients around the world
Available in Argentina, United States, Spain
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants. The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS). The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years. A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
Novartis Pharmaceuticals
2Research sites
800Patients around the world
This study is for people with
Multiple sclerosis
Relapsing remitting multiple sclerosis
Requirements for the patient
To 55 Years
All Gender
Medical requirements
Sites
STAT Research - CABA
STAT Research - CABA
Recruiting
Av. Callao 875, CABA, Buenos Aires
Instituto de Neurología Cognitiva (INECO)
Recruiting
Marcelo Torcuato de Alvear 1632, C1021 Cdad. Autónoma de Buenos Aires, Argentina
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