Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis

Study Purpose

This study is being done to test the safety and efficacy of LY3016859 for the treatment of osteoarthritis pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
  • - 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 presence of index knee pain for >12 weeks at screening.
  • - Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
  • - Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

  • - Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
  • - 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.
  • - Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
  • - Have presence of surgical hardware or other foreign body in the index knee.
  • - Have an unstable index joint (such as a torn anterior cruciate ligament).
  • - Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
  • - Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
  • - Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
  • - Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
  • - Have a history of infection in the index joint.
  • - Have a history of arthritis due to crystals (e.g., gout, pseudogout).
  • - Have pain or functional impairment due to ipsilateral hip osteoarthritis.
  • - Have had an intra-articular injection of hyaluronic acid within 24 weeks of screening.
  • - Have an estimated glomerular filtration rate (eGFR) of less than 70 milliliters/minute/1.73m² during screening.
  • - Have any clinically serious or unstable cardiovascular, musculoskeletal disorder, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of baseline.
  • - Have received any antibodies against nerve growth factor (NGF), or antibodies against EGFR, or EGFR tyrosine kinase inhibitors.
  • - Have a history of allergic reactions to monoclonal antibodies, or clinically significant multiple or severe drug allergies, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
  • - Have a history or presence of uncontrolled asthma, eczema, significant atopy, significant hereditary angioedema or common variable immune deficiency.
  • - Have hade any joint replacement such as joint knee of the lower extremity such as hip, knee, or ankle in the past 6 months.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04456686
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3016859

LY3016859 given intravenously (IV).

Placebo Comparator: Placebo

Placebo given IV.

Interventions

Drug: - LY3016859

LY3016859 given IV.

Drug: - Placebo

Placebo given IV.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Simon Williamson Clinic, Birmingham, Alabama

Status

Recruiting

Address

Simon Williamson Clinic

Birmingham, Alabama, 35211

Synexus- Chandler, Chandler, Arizona

Status

Recruiting

Address

Synexus- Chandler

Chandler, Arizona, 85224

Synexus Clinical Research - Glendale, Glendale, Arizona

Status

Recruiting

Address

Synexus Clinical Research - Glendale

Glendale, Arizona, 85306

Irvine Clinical Research Center, Irvine, California

Status

Recruiting

Address

Irvine Clinical Research Center

Irvine, California, 92614

Artemis Institute for Clinical Research, Riverside, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

Riverside, California, 92503

Artemis Institute for Clinical Research, San Diego, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

San Diego, California, 92103

Suncoast Research Group, Miami, Florida

Status

Recruiting

Address

Suncoast Research Group

Miami, Florida, 33135

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Synexus - US, Orlando, Florida

Status

Recruiting

Address

Synexus - US

Orlando, Florida, 32806

Synexus - US, Pinellas Park, Florida

Status

Recruiting

Address

Synexus - US

Pinellas Park, Florida, 33781

Gold Coast Research, Plantation, Florida

Status

Recruiting

Address

Gold Coast Research

Plantation, Florida, 33317

The Villages, Florida

Status

Recruiting

Address

Synexus Clinical Research US, Inc - Orlando

The Villages, Florida, 32162

Synexus Clinical Research, Chicago, Illinois

Status

Recruiting

Address

Synexus Clinical Research

Chicago, Illinois, 60602

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Cotton O'Neil Infusion Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O'Neil Infusion Center

Topeka, Kansas, 66606

ActivMed Practices and Research, Methuen, Massachusetts

Status

Recruiting

Address

ActivMed Practices and Research

Methuen, Massachusetts, 01844

MedVadis Research Corporation, Waltham, Massachusetts

Status

Recruiting

Address

MedVadis Research Corporation

Waltham, Massachusetts, 02451

Great Lakes Research Group, Inc., Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

StudyMetrix Research, Saint Peters, Missouri

Status

Recruiting

Address

StudyMetrix Research

Saint Peters, Missouri, 63303

Synexus - US, Omaha, Nebraska

Status

Recruiting

Address

Synexus - US

Omaha, Nebraska, 68144

PharmQuest, Greensboro, North Carolina

Status

Recruiting

Address

PharmQuest

Greensboro, North Carolina, 27408

Synexus - Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

Synexus - Cincinnati

Cincinnati, Ohio, 45236

Rapid Medical Research, Cleveland, Ohio

Status

Recruiting

Address

Rapid Medical Research

Cleveland, Ohio, 44122

Aventiv Research Inc, Columbus, Ohio

Status

Recruiting

Address

Aventiv Research Inc

Columbus, Ohio, 43213

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Clinical Research Center of Reading,LLC, Wyomissing, Pennsylvania

Status

Recruiting

Address

Clinical Research Center of Reading,LLC

Wyomissing, Pennsylvania, 19610

Coastal Carolina Research Center, North Charleston, South Carolina

Status

Recruiting

Address

Coastal Carolina Research Center

North Charleston, South Carolina, 29405

Synexus - US, Dallas, Texas

Status

Recruiting

Address

Synexus - US

Dallas, Texas, 75234

Synexus - US, San Antonio, Texas

Status

Recruiting

Address

Synexus - US

San Antonio, Texas, 78229

Synexus - US, Murray, Utah

Status

Recruiting

Address

Synexus - US

Murray, Utah, 84123

Northwest Clinical Research Center, Bellevue, Washington

Status

Recruiting

Address

Northwest Clinical Research Center

Bellevue, Washington, 98007-4209

Rainier Clinical Research Center, Renton, Washington

Status

Recruiting

Address

Rainier Clinical Research Center

Renton, Washington, 98057

International Sites

Latin Clinical Trial Center, San Juan, Puerto Rico

Status

Recruiting

Address

Latin Clinical Trial Center

San Juan, , 00909