Multiple Sclerosis, Relapsing Multiple Sclerosis
Conditions
Keywords
Relapsing Forms Multiple Sclerosis
Brief summary
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
Interventions
DRUGPlacebo
Administered orally
DRUGPirtobrutinib
Administered orally
Sponsors
Eli Lilly and Company
Loxo Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Puerto Rico, United States
Outcome results
None listed