P3-IMU-838-RMS-02 (ENSURE-2)
Research type
Research Study
Full title
A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)
IRAS ID
305911
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Immunic AG
Eudract number
2021-000029-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 1 months, 1 days
Research summary
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. It affects up to 2.5 million people worldwide. Its prevalence varies between races and geographical latitudes; within Europe alone, the prevalence ranges from more than 100 per 100,000 people in Northern and Central Europe to 50 per 100,000 people in Southern Europe.
Classification of the clinical forms of MS have been changing over time. While traditional terminology recognized 4 forms, namely primary progressive, progressive-relapsing, secondary progressive, and relapsing-remitting, more recent terminology interlaces the clinical descriptors “active” vs “inactive” and “relapsing” vs “progressive” MS. This study will focus on a population of patients with active relapsing MS (RMS).The investigational product IMU-838 (vidofludimus calcium) is a novel compound small molecule that selectively inhibits human dihydroorotate dehydrogenase (DHODH). This compound constitutes a novel chemical class and has no structural similarity to other known pharmaceuticals, or to the currently approved DHODH inhibitors, leflunomide and teriflunomide. Immunic AG is developing IMU-838 for a range of acute viral, chronic inflammatory, and autoimmune diseases.
IMU-838 may represent a novel and efficacious oral treatment option for patients with active RMS fostering adherence. Trial P3-IMU-838- RMS-02 will evaluate the efficacy, safety, and tolerability of IMU-838 in patients with active RMS.The clinical trial is funded by Immunic AG and it is planned to include approximately 80 - 120 study sites in approximately 10 - 15 countries in Europe, Asia, Africa, and America. Approximately 1050 patients are planned to be enrolled and randomized (525 patients per treatment arm). This study is designed as a placebo-controlled study, with a maximum 72-week follow-up period and an optional open-label IMU-838 treatment period up to 8 years.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0003
Date of REC Opinion
14 Feb 2022
REC opinion
Further Information Favourable Opinion