Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

The Boster Center for Multiple Sclerosis

Boston, MA

Clearwater, FL

Naples, FL

Phoenix, AZ

Fullerton, CA

Zenas BioPharma

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Find clinical trials for Multiple Sclerosis (MS) in Indianapolis, IN

Related conditions:

Multiple Sclerosis (MS) trials near Indianapolis, IN, USA:

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Find clinical trials for Multiple Sclerosis (MS) in .css-epvm6{white-space:nowrap;}Indianapolis, IN

Related conditions:

Multiple Sclerosis (MS) trials near Indianapolis, IN, USA:

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Find clinical trials for Multiple Sclerosis (MS) in Indianapolis, IN