Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Osteo Arthritis Knee

In brief

The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the treatment of knee pain due to with osteoarthritis (OA). 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

NCT05080660

Run by

Eli Lilly and Company

People needed

160

Starts

2021-10-12

Expected to finish

2022-06-06

Last updated by the study team

2024-07-17

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…

• 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 fibromyalgia
• 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 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, pseudo gout).
• Have pain or functional impairment due to ipsilateral hip osteoarthritis.
• Are pregnant or breastfeeding.

Where it is running

• Synexus- Chandler — Chandler, Arizona, United States
• Synexus Clinical Research - Glendale — Glendale, Arizona, United States
• Alliance for Multispecialty Research, LLC Tempe — Tempe, 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 — Hamden, Connecticut, United States
• VIN-Julie Schwartzbard — Aventura, Florida, United States
• Suncoast Research Group — 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
• Synexus Clinical Research US, Inc - Orlando — The Villages, Florida, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Synexus Clinical Research US, Inc. — Chicago, Illinois, 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
• Synexus - Cincinnati — Cincinnati, Ohio, United States
• META Medical Research Institute — Dayton, Ohio, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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