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

Multiple Sclerosis Clinical Trial

Official title:

A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06104683
• Other study ID #: 18690
• Secondary ID: J2N-MC-KLAA2022-
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: February 13, 2026

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 13, 2026
• Est. primary completion date: January 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Placebo
Administered orally
• Pirtobrutinib
Administered orally

Locations

Country	Name	City	State
Puerto Rico	Caribbean Center For Clinical Research Inc	Guaynabo
United States	Clinical Trial Network	Houston	Texas
United States	Swedish Medical Center-501 E Hampden Ave	Seattle	Washington
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Loxo Oncology, Inc.	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan		Week 8 and Week 12
Primary	Number of New and/or Enlarging T2 Lesions		Week 12
Secondary	Total Number of T1 Gd-Enhancing Lesions Per Scan		Week 8 and Week 12
Secondary	Total Number of Gd-Enhancing Lesions Per Scan		Week 8 and Week 12
Secondary	Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib		Baseline to Week 12