A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (OA05)

Lilly

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: LY3857210; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620563

18338

H0P-MC-OA05 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 2 patient groups, including a placebo group

45 mg LY3857210

Experimental group

Description:

Participants received 45 milligram (mg) LY3857210 orally once daily for up to 8 weeks.

Treatment:

Drug: LY3857210

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once daily for up to 8 weeks.

Treatment:

Drug: Placebo