Clinical Trial: MoonStone

Relapsing Multiple Sclerosis

This is a Phase 2, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with RMS. The study consists of a Screening Period (Day 28 to Day -1), followed by a 24-week Treatment Period (Part A or RCP consists of 12 doses of obexelimab or placebo; Part B or OLP consists of 12 doses of open-label obexelimab), a 52-week OLE and an expected 12-week Follow-up Period.

Inclusion Criteria:

• Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
• An EDSS of ≤ 5.5 at the Screening Visit
• Must have documentation of:
  • At least 1 relapse within the previous year OR
  • ≥ 2 relapses within the past 2 years OR
  • ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
• Not of childbearing potential or willing to follow contraceptive guidance

Exclusion Criteria:

• Primary progressive MS or secondary progressive MS without relapses
• Meet criteria for neuromyelitis optica spectrum disorder
• Relapse in the 30 days prior to randomization
• ≥ 10 years disease duration from onset with patient’s EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
• Has > 20 Gd+ lesions on brain MRI at screening

To see if you qualify, and to learn more or sign up, please visit the study site here.

For questions email [email protected] or call 833-269-4696.