NCT04529096CompletedPhase 2
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Chronic Low Back Pain
Eli Lilly and Company27 sites in 2 countries149 target enrollmentStarted: August 25, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 149
- Locations
- 27
- Primary Endpoint
- Change From Baseline for Average Pain Intensity as Measured by the NRS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
- •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.
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 compression fracture.
- •Have had a recent major trauma (within 6 months of baseline).
- •Have a history of low back pain as classified by the Quebec Task Force Categories 4 through
- •Are using spinal cord stimulator or dorsal root ganglion stimulator.
- •Have fibromyalgia.
Arms & Interventions
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
Intervention: LY3016859 (Drug)
Placebo
Placebo Comparator
Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline for Average Pain Intensity as Measured by the NRS
Time Frame: Baseline, up to Week 8
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
Secondary Outcomes
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, up to Week 8)
- Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week(Baseline up to Week 8)
- 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 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)
- Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States)(Baseline, up to Week 8)
Investigators
Study Sites (27)
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