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

Sponsor

Loxo Oncology, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06104683

Collaborator

Eli Lilly and Company (Industry)

200

Enrollment

Arms

22.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsing Multiple Sclerosis Multiple Sclerosis	Drug: Placebo Drug: Pirtobrutinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jun 24, 2025

Anticipated Study Completion Date :

Sep 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Participants will receive placebo orally.	Drug: Placebo Administered orally

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Loxo Oncology, Inc.
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loxo Oncology, Inc.

ClinicalTrials.gov Identifier:

NCT06104683

Other Study ID Numbers:

18690
J2N-MC-KLAA
2022-502376-24-00

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Loxo Oncology, Inc.

Relapsing Forms Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Pirtobrutinib

Study Results

No Results Posted as of Oct 27, 2023