A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (CPMP)

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Chronic Low-back Pain; Diabetic Neuropathic Pain; Osteoarthritis, Knee

Treatments: Drug: LY3016859 ISA; Drug: Placebo Oral; Drug: LY3526318 ISA; Drug: LY3556050 ISA; Drug: LY3857210 ISA; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05986292

17511

H0P-MC-CPMP (Other Identifier)

Details and patient eligibility

About

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Full description

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have a visual analog scale (VAS) pain value >40 and <95 at screening and prerandomization 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 kilogram/square meter (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, except rescue medication for the duration of the study

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 fibromyalgia
• have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
• 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
• have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10,000 participants in 12 patient groups

LY3016859 Osteoarthritis ISA

Experimental group

Description:

Participants are randomized to receive either active LY3016859 or matching placebo

Treatment:

Drug: Placebo

Drug: LY3016859 ISA

LY3016859 Diabetic Neuropathic Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3016859 or matching placebo

Treatment:

Drug: Placebo

Drug: LY3016859 ISA

LY3016859 Chronic Back Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3016859 or matching placebo

Treatment:

Drug: Placebo

Drug: LY3016859 ISA

LY3556050 Osteoarthritis ISA

Experimental group

Description:

Participants are randomized to receive either active LY3556050 or matching placebo

Treatment:

Drug: LY3556050 ISA

Drug: Placebo Oral

LY3556050 Diabetic Neuropathic Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3556050 or matching placebo

Treatment:

Drug: LY3556050 ISA

Drug: Placebo Oral

LY3556050 Chronic Back Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3556050 or matching placebo

Treatment:

Drug: LY3556050 ISA

Drug: Placebo Oral

LY3526318 Osteoarthritis ISA

Experimental group

Description:

Participants are randomized to receive either active LY3526318 or matching placebo

Treatment:

Drug: Placebo Oral

Drug: LY3526318 ISA

LY3526318 Diabetic Neuropathic Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3526318 or matching placebo

Treatment:

Drug: Placebo Oral

Drug: LY3526318 ISA

LY3526318 Chronic Back Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3526318 or matching placebo

Treatment:

Drug: Placebo Oral

Drug: LY3526318 ISA

LY3857210 Osteoarthritis ISA

Experimental group

Description:

Participants are randomized to receive either active LY3857210 or matching placebo

Treatment:

Drug: LY3857210 ISA

Drug: Placebo Oral

LY3857210 Diabetic Neuropathic Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3857210 or matching placebo

Treatment:

Drug: LY3857210 ISA

Drug: Placebo Oral

LY3857210 Chronic Back Pain ISA

Experimental group

Description:

Participants are randomized to receive either active LY3857210 or matching placebo

Treatment:

Drug: LY3857210 ISA

Drug: Placebo Oral