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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06104683
Other study ID # 18690
Secondary ID J2N-MC-KLAA2022-
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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