Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain
NCT ID: NCT04529096
Last Updated: 2023-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2020-08-25
2021-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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750 Mg-500 mg LY3016859
Participants received LY3016859 every 2 weeks with 750 milligram (mg) as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses
LY3016859
Administered IV
Placebo
Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Placebo
Administered IV
Interventions
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LY3016859
Administered IV
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* Have a history of daily pain for at least 12 weeks based on participant report or medical history.
* Have a value of ≤30 on the pain catastrophizing scale.
* Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
* Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
* Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.
* Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
* Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
* Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
* Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement \>450 milliseconds (msec) for male participants, \>470 msec for female participants, or \>480 msec for participants with bundle branch block.
* Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
* Have a positive human immunodeficiency virus (HIV) test result at screening.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have an intolerance to acetaminophen or paracetamol or any of its excipients.
* Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
* Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
* Have history of or current compression fracture.
* Have had a recent major trauma (within 6 months of baseline).
* Have a history of low back pain as classified by the Quebec Task Force Categories 4 through 11.
* Are using spinal cord stimulator or dorsal root ganglion stimulator.
* Have fibromyalgia.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Simon Williamson Clinic
Birmingham, Alabama, United States
Synexus - US
Chandler, Arizona, United States
Synexus- Chandler
Chandler, Arizona, United States
Irvine Clinical Research Center
Irvine, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Synexus - US
Orlando, Florida, United States
Synexus - US
Pinellas Park, Florida, United States
Martin E. Hale M.D., P.A.
Plantation, Florida, United States
Synexus - US
The Villages, Florida, United States
Synexus Clinical Research
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Cotton O'Neil Infusion Center
Topeka, Kansas, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Synexus - US
Omaha, Nebraska, United States
PharmQuest
Greensboro, North Carolina, United States
Synexus - Cincinnati
Cincinnati, Ohio, United States
Rapid Medical Research
Cleveland, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Synexus - US
Dallas, Texas, United States
Synexus - San Antonio
San Antonio, Texas, United States
Synexus - US
Murray, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Latin Clinical Trial Center
San Juan, PR, Puerto Rico
Countries
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References
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James DE, Bailey J, van der Walt JS, Winkler J, Schoemaker R. Population Pharmacokinetics and Pharmacodynamics of Fepixnebart (LY3016859) and Epiregulin in Patients with Chronic Pain. Clin Pharmacokinet. 2025 May;64(5):757-767. doi: 10.1007/s40262-025-01506-3. Epub 2025 Apr 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain
Other Identifiers
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H0P-MC-BP01
Identifier Type: OTHER
Identifier Source: secondary_id
17536
Identifier Type: -
Identifier Source: org_study_id