Study Stopped
Sponsor Decision: The trial has been withdrawn with no plans to continue development.
A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis
A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients With Relapsing Multiple Sclerosis
3 other identifiers
interventional
N/A
2 countries
4
Brief Summary
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2026
CompletedMarch 27, 2024
March 1, 2024
1.7 years
October 24, 2023
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
Week 8 and Week 12
Number of New and/or Enlarging T2 Lesions
Week 12
Secondary Outcomes (3)
Total Number of T1 Gd-Enhancing Lesions Per Scan
Week 8 and Week 12
Total Number of Gd-Enhancing Lesions Per Scan
Week 8 and Week 12
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib
Baseline to Week 12
Study Arms (4)
Pirtobrutinib Dose 1
EXPERIMENTALParticipants will receive pirtobrutinib orally.
Pirtobrutinib Dose 2
EXPERIMENTALParticipants will receive pirtobrutinib orally.
Pirtobrutinib Dose 3
EXPERIMENTALParticipants will receive pirtobrutinib orally.
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Participants must have been diagnosed with relapsing MS
- Participants must have one of the following
- at least 1 documented relapse within the previous year, or
- at least 2 documented relapse within the previous 2 years, or
- at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loxo Oncology, Inc.lead
- Eli Lilly and Companycollaborator
Study Sites (4)
University of South Florida
Tampa, Florida, 33612, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Swedish Medical Center-501 E Hampden Ave
Seattle, Washington, 98122-5698, United States
Caribbean Center For Clinical Research Inc
Guaynabo, 969, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
October 27, 2023
Study Start
May 1, 2024
Primary Completion
January 16, 2026
Study Completion
February 13, 2026
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.