Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain

NCT04529096 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 17536H0P-MC-BP01
• Study Type: interventional
• Target: 149
• Locations: 2 countries
• Sites: 34

Brief Summary

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of chronic low back 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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline for Average Pain Intensity as Measured by the NRS

  The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals

  Baseline, up to Week 8

Secondary Outcomes (7)

• Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)

  Baseline, up to Week 8

• Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change (PGI)

  Baseline, up to Week 8

• Change From Baseline for Worst Pain Intensity as Measured by NRS

  Baseline, up to Week 8

• Change From Baseline on the Visual Analog Scale (VAS) for Pain

  Baseline, up to Week 8

• Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale)

  Baseline, up to Week 8

Study Arms (2)

750 Mg-500 mg LY3016859

EXPERIMENTAL

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

Drug: LY3016859

Placebo

PLACEBO COMPARATOR

Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.

Drug: Placebo

Interventions

LY3016859 DRUG

Administered IV

750 Mg-500 mg LY3016859

Placebo DRUG

Administered IV

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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 a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
• Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
• Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.
• Are men, or women able to abide by reproductive and contraceptive requirements.

You may not qualify if:

• 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 used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
• Have history of or current compression fracture.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (34)

Simon Williamson Clinic

Birmingham, Alabama, 35211, United States

Location

Synexus - US

Chandler, Arizona, 85224, United States

Location

Synexus- Chandler

Chandler, Arizona, 85224, United States

Location

Irvine Clinical Research Center

Irvine, California, 92614, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

VIN-Julie Schwartzbard

Aventura, Florida, 33180, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Synexus - US

Orlando, Florida, 32806, United States

Location

Synexus - US

Pinellas Park, Florida, 33781, United States

Location

Martin E. Hale M.D., P.A.

Plantation, Florida, 33317, United States

Location

Synexus - US

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research

Chicago, Illinois, 60602, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Cotton O'Neil Infusion Center

Topeka, Kansas, 66606, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Synexus - US

Omaha, Nebraska, 68144, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Synexus - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Research Center of Reading,LLC

Wyomissing, Pennsylvania, 19610, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Synexus - US

Dallas, Texas, 75234, United States

Location

Synexus - San Antonio

San Antonio, Texas, 78229, United States

Location

Synexus - US

Murray, Utah, 84123, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007-4209, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Latin Clinical Trial Center

San Juan, PR, 00909, Puerto Rico

Location

Related Publications (1)

• James DE, Bailey J, van der Walt JS, Winkler J, Schoemaker R. Population Pharmacokinetics and Pharmacodynamics of Fepixnebart (LY3016859) and Epiregulin in Patients with Chronic Pain. Clin Pharmacokinet. 2025 May;64(5):757-767. doi: 10.1007/s40262-025-01506-3. Epub 2025 Apr 23.

  PMID: 40266472 DERIVED

Related Links

• Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 27, 2020
• Study Start: August 25, 2020
• Primary Completion: June 4, 2021
• Study Completion: October 4, 2021
• Last Updated: November 30, 2023
• Results First Posted: June 23, 2022

Record last verified: 2023-11-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PR (1); US (33)