A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain. This trial is part of the chronic pain master protocol, H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Key facts

Study ID: NCT05620563
Run by: Eli Lilly and Company
People needed: 147
Starts: 2022-11-22
Expected to finish: 2023-06-12
Last updated by the study team: 2024-06-26

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 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.

You may not qualify if…

A seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure
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.
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 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 any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.
Are pregnant or breastfeeding.

Where it is running

Synexus Clinical Research US, Inc. — Chandler, Arizona, United States
Arizona Research Center — Phoenix, Arizona, United States
Artemis Institute for Clinical Research — Riverside, California, United States
Artemis Institute for Clinical Research — San Diego, California, United States
CMR of Greater New Haven, LLC — Hamden, Connecticut, United States
Accel Research Sites- Clinical Research Unit — DeLand, Florida, United States
Suncoast Research Group — Miami, Florida, United States
University of Miami — Miami, Florida, United States
New Horizon Research Center — Miami, Florida, United States
Renstar Medical Research — Ocala, Florida, United States
Synexus Clinical Research US, Inc - Orlando — Orlando, Florida, United States
Synexus Clinical Research US, Inc. — Pinellas Park, Florida, United States
North Georgia Clinical Research — Woodstock, Georgia, United States
Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
Northwestern University — Chicago, Illinois, United States
Boston Clinical Trials — Boston, Massachusetts, 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
Clinvest Research LLC — Springfield, Missouri, United States
Lillestol Research — Fargo, North Dakota, United States
META Medical Research Institute — Dayton, Ohio, United States
Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
FutureSearch Trials of Neurology — Austin, Texas, United States

Full record on ClinicalTrials.gov

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