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

• ClinicalTrials.gov Identifier: NCT04529096
• Recruitment Status: Recruiting
• First Posted: August 27, 2020
• Last Update Posted: January 20, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: August 25, 2020
• First Posted Date: August 27, 2020
• Last Update Posted Date: January 20, 2021
• Actual Study Start Date: August 25, 2020
• Estimated Primary Completion Date: May 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2020)

Change from Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, up to Week 8 ]

Change from Baseline for Average Pain Intensity as Measured by the NRS

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2020)

• Change from Baseline on the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline on the RMDQ
• Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
• Change from Baseline for Worst Pain Intensity as Measured by NRS [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline for Worst Pain Intensity as Measured by NRS
• Change from Baseline on the Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline on the VAS for Pain
• Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline on the Sleep Scale from the MOS Sleep Scale
• Total Amount of Rescue Medication [ Time Frame: Baseline up to Week 8 ]
  Total Amount of Rescue Medication
• Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to Week 8 ]
  Change from Baseline on the EQ-5D-5L

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain
• Official Title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Chronic Low Back Pain
• 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) which is a protocol to accelerate the development of new treatments for chronic pain.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Low-back Pain

Intervention

• Drug: LY3016859
  Administered IV
• Drug: Placebo
  Administered IV

Study Arms

• Experimental: LY3016859
  LY3016859 administered intravenously (IV).
  Intervention: Drug: LY3016859
• Placebo Comparator: Placebo
  Placebo administered IV.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 25, 2020): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 5, 2022
• Estimated Primary Completion Date: May 5, 2021 (Final data collection date for primary outcome measure)

Eligibility 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 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 pain medications for condition under study, except rescue medication permitted per protocol, 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.
• Have an estimated glomerular filtration rate (eGFR) of less than 70 ml/min/1.73m² during screening.
• Have any clinically serious or unstable cardiovascular, musculoskeletal disorder, gastrointestinal (GI), endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of baseline.
• Have received any antibodies against nerve growth factor (NGF), antibodies against EGFR, or EGFR tyrosine kinase inhibitors (TKI).
• 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.
• 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 used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
• Have history of or current osteoporotic compression fracture.
• Have had a recent major trauma (within 6 months of baseline).
• Have had surgical intervention for the treatment of low back pain in the past 6 months.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; 1-317-615-4559; clinicaltrials.gov@lilly.com

• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT04529096
• Other Study ID Numbers: 17536; H0P-MC-BP01 ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (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.
• URL: https://vivli.org/

• Responsible Party: Eli Lilly and Company
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: 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

• PRS Account: Eli Lilly and Company
• Verification Date: January 2021