Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Placebo; Drug: LY3016859

Study type: Interventional

Funder types: Industry

Identifiers

NCT04476108

17535

H0P-MC-NP01 (Other Identifier)

Details and patient eligibility

About

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic 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: 125 patients

Sex: All

Ages: 18+ 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 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 daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
• Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
• Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
• 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.
• Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
• Have known hereditary motor, sensory or autonomic neuropathies.
• 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 megaloblastic anemia or combined degeneration of the spinal cord.
• 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 angio-edema or common variable immune deficiency.
• Have fibromyalgia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups, including a placebo group

750 Mg-500 mg LY3016859

Experimental group

Description:

Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses.

Treatment:

Drug: LY3016859

Placebo

Placebo Comparator group

Description:

Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.

Treatment:

Drug: Placebo