A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-02-13

Brief Summary

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The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.

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Detailed Description

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Conditions

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Relapsing Multiple Sclerosis Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pirtobrutinib Dose 1

Participants will receive pirtobrutinib orally.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Pirtobrutinib Dose 2

Participants will receive pirtobrutinib orally.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Pirtobrutinib Dose 3

Participants will receive pirtobrutinib orally.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Placebo

Participants will receive placebo orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Placebo

Administered orally

Intervention Type DRUG

Pirtobrutinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3527727

Eligibility Criteria

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Inclusion Criteria

* Participants must have been diagnosed with relapsing MS
* Participants must have one of the following

1. at least 1 documented relapse within the previous year, or
2. at least 2 documented relapse within the previous 2 years, or
3. at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.

Exclusion Criteria

* Have had a diagnosis of primary progressive MS
* Have a history of another clinically significant neurological disease
* Had a relapse of MS within 30 days prior to randomization.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No