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

Phase 2

Withdrawn

• Conditions: Relapsing Multiple Sclerosis; Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: Pirtobrutinib

• Registration Number: NCT06104683
• Lead Sponsor: Loxo Oncology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Study Start: 2024-05-01
• Primary Completion: 2026-01-16
• Study Completion: 2026-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo orally.
Pirtobrutinib Dose 3	Pirtobrutinib	Participants will receive pirtobrutinib orally.
Pirtobrutinib Dose 2	Pirtobrutinib	Participants will receive pirtobrutinib orally.
Pirtobrutinib Dose 1	Pirtobrutinib	Participants will receive pirtobrutinib orally.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib	Baseline to Week 12
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

Trial Locations

Locations (4)

Clinical Trial Network; 🇺🇸 Houston, Texas, United States

Swedish Medical Center-501 E Hampden Ave; 🇺🇸 Seattle, Washington, United States

Caribbean Center For Clinical Research Inc; 🇵🇷 Guaynabo, Puerto Rico

University of South Florida; 🇺🇸 Tampa, Florida, United States