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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-MC-KLAA | Other Identifier | Eli Lilly and Company | |
| 2022-502376-24-00 | Other Identifier | EU Trial Number |
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Sponsor Decision: The trial has been withdrawn with no plans to continue development.
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib Dose 1 | Experimental | Participants will receive pirtobrutinib orally. |
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| Pirtobrutinib Dose 2 | Experimental | Participants will receive pirtobrutinib orally. |
|
| Pirtobrutinib Dose 3 | Experimental | Participants will receive pirtobrutinib orally. |
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| Placebo | Placebo Comparator | Participants will receive placebo orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| Pirtobrutinib |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Participants must have been diagnosed with relapsing MS
Participants must have one of the following
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States | ||
| Clinical Trial Network |
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Drug |
Administered orally |
|
|
| Baseline to Week 12 |
| 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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