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

• Status: Not yet recruiting
• Trial end date: 2023-08-07
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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 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.

• 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 a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.

• Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.

• Are taking metformin therapy.

• Are pregnant or breastfeeding.

• Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.