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

March 25, 2024 updated by: Loxo Oncology, Inc.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 969
        • Caribbean Center for Clinical Research Inc
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
    • Washington
      • Seattle, Washington, United States, 98122-5698
        • Swedish Medical Center-501 E Hampden Ave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally.
Drug: Placebo
Administered orally
Experimental: Pirtobrutinib Dose 1
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Administered orally
Other Names:
  • LY3527727
Experimental: Pirtobrutinib Dose 2
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Administered orally
Other Names:
  • LY3527727
Experimental: Pirtobrutinib Dose 3
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Administered orally
Other Names:
  • LY3527727

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Number of T1 Gd-Enhancing Lesions Per Scan
Time Frame: Week 8 and Week 12
Week 8 and Week 12
Total Number of Gd-Enhancing Lesions Per Scan
Time Frame: Week 8 and Week 12
Week 8 and Week 12
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 16, 2026

Study Completion (Estimated)

February 13, 2026

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18690
  • J2N-MC-KLAA (Other Identifier: Eli Lilly and Company)
  • 2022-502376-24-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe