Multiple Sclerosis Studies

Phase III Study of Evobrutinib in RMS

MERCK SERAONO: MS200527ˍ0082 Objective: characterize the efficacy and safety of evobrutinib 45 mg administered orally twice daily versus teriflunomide (Aubagio, 14 mg once a day orally) in participants with relapsing multiple sclerosis (RMS).

  • PI: AJAY GUPTA, MD
  • CONTACT ASHLEE X 3214
  • Duration 2-year study.

KEY INCLUSION CRITERIA

  • Ages 18 to 55
  • Diagnosed RMS or SPMS

KEY EXCLUSION CRITERIA

  • Primary progressive MS
  • SPMS without relapse
  • Uses of corticosteroid
  • Immunologic disorder other than MS, or any other condition requiring oral, IV, intramuscular, or intraarticular corticosteroid therapy, except for well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.

CELGENE: RPC-1063-MS-001

Study Title a Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod (RPC-1063)

  • PI AJAY GUPTA MD
  • CONTACT AARON X3107
  • DURATION: 3-year study

KEY INCLUSION CRITERIA

  • Ages 18 to 65
  • Diagnosed MS
  • < 5 years since time of RMS diagnosis
  • <1 approved RMS DMT

KEY EXCUSION CRITERIA

  • Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or would the subject at risk by participating in the study. Subjects with mild or moderate asthmas, and subjects with other mild pulmonary disease may be included in the study.
  • Progressive neurologic disability
  • Visual or other sensorimotor impairment likely to confound test performance
  • History of developmental disorder

ROCHE GENTECH: GN41851

Study GN41851 is a Phase 3 study, randomized, multicenter, double-blind, double-dummy, parallel-secondary progressive MS, collectively referred to RMS.

  • PI: AJAY GUPTA, MD
  • CONTACT AARON X 3107
  • DURATION APPOX 2 YEARS

KEY INCLUSION CRITERIA

  • Ages 18 to 55
  • Diagnosed with RMS
  • Ability to complete the 9-hole peg test for each hand in <240 seconds.
  • Ability to perform the timed 25 ft walk test.

KEY EXCLUSION CRITERIA

  • Disease duration of >10 years for the onset of symptoms.
  • A diagnosis of PPMS or not-active SPMS
  • Chronic treatment with systemic corticosteroids or immunosuppressants.
  • History of alcohol or other drug abuse within 12 months.

SANOFI SAR442168

A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (GEMINI 2)

  • PI: AJAY GUPTA, MD
  • CONTACT ASHLEE X 3214
  • DURATION APPROXIMATELY 3 YEAR STUDY

KEY INCLUSION CRITERIA

  • Ages 18 to 55
  • Diagnosed RMS
  • The participant must have at least 1 of the following prior to screening: > 1 documented relapse within the previous year or > 2 documented relapses within the previous 2 years or > 1 documented GD enhancing lesion on an MRI scan within the previous year.

KEY EXCLUSION CRITERIA

  • Primary progressive MS
  • SPMS without relapse
  • History or risk of an infection
  • Psychiatric disturbance or substance abuse
  • The participant is receiving anticoagulant/antiplatelet therapies.