LY3541860 in Adult Rabbit Models of Relapsing Multiple Sclerosis
An interim analysis of a Phase 2 study tested LY3541860 against a placebo for its effect on new T1 gadolinium-enhancing lesions in adults with relapsing multiple sclerosis. The data did not show the intended treatment effect.
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Why it matters
The study aimed to evaluate a potential new treatment for relapsing multiple sclerosis, which could provide options for patients with limited current therapies. However, as there are no results available, the impact of these findings is unclear.
What this does not prove
No results for the study are posted, and the planned enrolment and endpoints do not constitute findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- All
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (10)
study phaseThe study will last about 9 months with additional 6 months follow-up.
study design"officialTitle": "An Adaptive Phase 2a/2b, Randomized, Double-Blind, Parallel-Group Study to Investigate the Safety and Efficacy of LY3541860 Compared to Placebo in Slowing the Occurrence of New T1 Gadolinium-Enhancing Lesions in Adult Participants With Relapsing Multiple Sclerosis"
subjectsAdult Participants With Relapsing Multiple Sclerosis
relevant ms types2018) with a relapsing course (RMS) activity according to Klineova and Lublin 2018.\n* Participants must have 1 of these:\n\n * at least 1 documented relapse within the previous year\n * at least 2 documented relapses within the previous 2 years, or\n * at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.\n* Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.\n\nExclusion Criteria:\n\n* Have had a diagnosis of:\n\n * primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al.
intervention"description": "LY3541860 will be given intravenously (IV)",
comparatorPlacebo will be given IV.
primary endpoint"measure": "Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions",
follow upThe study will last about 9 months with additional 6 months follow-up.
findingsThe interim analysis data failed to demonstrate the intended treatment effect.
limitationsNo results are posted.
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