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

WithdrawnPhase 2Relapsing MSNCT06104683

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Sponsor Decision: The trial has been withdrawn with no plans to continue development.

What was tested

Treatment tested

Pirtobrutinib
Tyrosine-protein kinase BTK inhibitor

Placebo or sham

Placebo

What it measured

Main measures

New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
Week 8 and Week 12
MRI lesions
Number of New and/or Enlarging T2 Lesions
Week 12
MRI lesions

Other measures (3)

Total Number of T1 Gd-Enhancing Lesions Per Scan
Week 8 and Week 12
MRI lesions
Total Number of Gd-Enhancing Lesions Per Scan
Week 8 and Week 12
MRI lesions
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib
Baseline to Week 12
How the body handles the medicine

Who could take part

Relapsing MS · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

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History

Started
May 2024
Main results due
Jan 2026
Finished
Feb 2026

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