Diabetic Peripheral Neuropathic Pain Trial In Puerto Rico, United ...

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Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain Sponsor Eli Lilly and Company (Industry) Overall Status Completed CT.gov ID NCT04476108 Collaborator (none) 125 Enrollment 36 Locations 2 Arms 15.9 Actual Duration (Months) 3.5 Patients Per Site 0.2 Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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) which is a protocol to accelerate the development of new treatments for chronic pain.

Condition or Disease Intervention/Treatment Phase
  • Diabetic Peripheral Neuropathic Pain
  • Drug: LY3016859
  • Drug: Placebo
 Phase 2

Study Design

Study Type: Interventional Actual Enrollment : 125 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Diabetic Peripheral Neuropathic Pain Actual Study Start Date : Jul 15, 2020 Actual Primary Completion Date : Jul 8, 2021 Actual Study Completion Date : Nov 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 750 Mg-500 mg LY3016859

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.

Drug: LY3016859 Administered IV

Placebo Comparator: Placebo

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

Drug: Placebo Administered IV

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Average Pain Intensity as Measured by the NRS [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.

Secondary Outcome Measures

  1. Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score [Baseline, up to Week 8]

    The BPI-SF is a numeric rating scale that assesses the severity of pain (severity scale), its impact on daily functioning (Interference scale), and other aspects of pain (for example, location of pain, relief from medications) in various disease states. BPI-SF score ranges from 0 = no pain to 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.

  2. Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [Baseline, up to Week 8]

    Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.

  3. Change From Baseline for Worst Pain Intensity as Measured by NRS [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 worst 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% CrI was derived using Bayesian mixed model repeated measures.

  4. Change From Baseline on the Visual Analog Scale (VAS) for Pain [Baseline, up to Week 8]

    VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0 = no pain, and 100 = worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.

  5. Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) [Baseline, up to Week 8]

    The MOS Sleep Scale consists of 12 questions addressing the past week. Participants reported how often each sleep symptom or problem was present on a 5-point categorical scale ranging from 'all of the time' to 'none of the time.' It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". MOS Sleep scale scores range from 0 (min) to 100 (max). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Higher scores represent worse outcomes. Posterior mean change from baseline, 95% CrI was derived using Bayesian longitudinal model.

  6. Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week [Baseline up to Week 8]

    Total Amount of Rescue Medication Use as Measured by Average Dosage per Week. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.

  7. Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States) [Baseline, up to Week 8]

    The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than death) with higher scores indicating better health: 0 = a health state equivalent to death, and 1 = perfect health. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.

Eligibility Criteria

Criteria

Ages Eligible for Study: 18 Years and Older Sexes Eligible for Study: 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Simon Williamson Clinic Birmingham Alabama United States 35211
2 Synexus - US Chandler Arizona United States 85224
3 Synexus Clinical Research - Glendale Glendale Arizona United States 85306
4 Irvine Clinical Research Center Irvine California United States 92614
5 Artemis Institute for Clinical Research Riverside California United States 92503
6 Artemis Institute for Clinical Research San Diego California United States 92103
7 VIN-Julie Schwartzbard Aventura Florida United States 33180
8 Clinical Research of South Florida Coral Gables Florida United States 33134
9 Suncoast Research Group Miami Florida United States 33135
10 Renstar Medical Research Ocala Florida United States 34470
11 Synexus - US Orlando Florida United States 32806
12 Synexus - US Pinellas Park Florida United States 33781
13 Martin E. Hale M.D., P.A. Plantation Florida United States 33317
14 Synexus Clinical Research US, Inc - Orlando The Villages Florida United States 32162
15 Synexus Clinical Research Chicago Illinois United States 60602
16 Northwestern University Chicago Illinois United States 60611
17 Cotton O'Neil Infusion Center Topeka Kansas United States 66606
18 Boston Clinical Trials Boston Massachusetts United States 02131
19 ActivMed Practices and Research Methuen Massachusetts United States 01844
20 MedVadis Research Corporation Waltham Massachusetts United States 02451
21 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
22 StudyMetrix Research Saint Peters Missouri United States 63303
23 Synexus - US Omaha Nebraska United States 68144
24 PharmQuest Greensboro North Carolina United States 27408
25 Synexus - Cincinnati Cincinnati Ohio United States 45236
26 Rapid Medical Research Cleveland Ohio United States 44122
27 Aventiv Research Inc Columbus Ohio United States 43213
28 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
29 Clinical Research Center of Reading,LLC Wyomissing Pennsylvania United States 19610
30 Coastal Carolina Research Center North Charleston South Carolina United States 29405
31 Synexus - US Dallas Texas United States 75234
32 Synexus - US San Antonio Texas United States 78229
33 Synexus - US Murray Utah United States 84123
34 Northwest Clinical Research Center Bellevue Washington United States 98007-4209
35 Rainier Clinical Research Center Renton Washington United States 98057
36 Latin Clinical Trial Center San Juan Puerto Rico 00909

Sponsors and Collaborators

  • Eli Lilly and Company

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

Study Documents (Full-Text)

  • Study Protocol - Mar 27, 2020
  • Statistical Analysis Plan - Dec 16, 2021

More Information

Additional Information:

  • A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain

Publications

None provided. Responsible Party: Eli Lilly and Company ClinicalTrials.gov Identifier: NCT04476108 Other Study ID Numbers:
  • 17535
  • H0P-MC-NP01
First Posted: Jul 17, 2020 Last Update Posted: Aug 3, 2022 Last Verified: Aug 1, 2022 Individual Participant Data (IPD) Sharing Statement: Yes Plan to Share IPD: Yes Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Neuralgia Diabetic Neuropathies

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title 750 Mg-500 Milligram (mg) LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Period Title: Overall Study
STARTED 84 41
Received at Least 1 Dose of Study Drug 83 41
COMPLETED 76 38
NOT COMPLETED 8 3

Baseline Characteristics

Arm/Group Title 750 Mg-500 mg LY3016859 Placebo Total
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. Total of all reporting groups
Overall Participants 84 41 125
Age (Count of Participants)
<=18 years 0 0% 0 0% 0 0%
Between 18 and 65 years 50 59.5% 24 58.5% 74 59.2%
>=65 years 34 40.5% 17 41.5% 51 40.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years] 61.6 (8.5) 63.3 (8.9) 62.2 (8.7)
Sex: Female, Male (Count of Participants)
Female 35 41.7% 14 34.1% 49 39.2%
Male 49 58.3% 27 65.9% 76 60.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native 1 1.2% 0 0% 1 0.8%
Asian 1 1.2% 2 4.9% 3 2.4%
Native Hawaiian or Other Pacific Islander 1 1.2% 0 0% 1 0.8%
Black or African American 12 14.3% 4 9.8% 16 12.8%
White 68 81% 33 80.5% 101 80.8%
More than one race 1 1.2% 1 2.4% 2 1.6%
Unknown or Not Reported 0 0% 1 2.4% 1 0.8%
Region of Enrollment (Count of Participants)
United States 84 100% 41 100% 125 100%
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale] 5.97 (1.69) 6.30 (1.62) 6.08 (1.66)

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Average Pain Intensity as Measured by the NRS
Description 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.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 70 38
Mean (95% Confidence Interval) [score on a scale] -1.98 -1.56
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%-1.17 to 0.32
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
2. Secondary Outcome
Title Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score
Description The BPI-SF is a numeric rating scale that assesses the severity of pain (severity scale), its impact on daily functioning (Interference scale), and other aspects of pain (for example, location of pain, relief from medications) in various disease states. BPI-SF score ranges from 0 = no pain to 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 75 38
Mean (95% Confidence Interval) [score on a scale] -2.11 -1.74
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%-1.09 to 0.35
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
3. Secondary Outcome
Title Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Description Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 76 38
Mean (95% Confidence Interval) [score on a scale] 2.48 2.75
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%-0.69 to 0.15
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
4. Secondary Outcome
Title Change From Baseline for Worst Pain Intensity as Measured by NRS
Description 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 worst 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% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 70 38
Mean (95% Confidence Interval) [score on a scale] -2.10 -1.66
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%-1.20 to 0.31
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
5. Secondary Outcome
Title Change From Baseline on the Visual Analog Scale (VAS) for Pain
Description VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0 = no pain, and 100 = worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 76 38
Mean (95% Confidence Interval) [score on a scale] -26.17 -23.31
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -2.86
Confidence Interval (2-Sided) 95%-11.71 to 6.06
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
6. Secondary Outcome
Title Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale)
Description The MOS Sleep Scale consists of 12 questions addressing the past week. Participants reported how often each sleep symptom or problem was present on a 5-point categorical scale ranging from 'all of the time' to 'none of the time.' It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". MOS Sleep scale scores range from 0 (min) to 100 (max). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Higher scores represent worse outcomes. Posterior mean change from baseline, 95% CrI was derived using Bayesian longitudinal model.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 76 38
Mean (95% Confidence Interval) [score on a scale] 0.21 -0.14
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%-0.09 to 0.78
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
7. Secondary Outcome
Title Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week
Description Total Amount of Rescue Medication Use as Measured by Average Dosage per Week. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 70 38
Mean (95% Confidence Interval) [mg per week] 271.58 271.24
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%-188.46 to 187.97
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
8. Secondary Outcome
Title Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States)
Description The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than death) with higher scores indicating better health: 0 = a health state equivalent to death, and 1 = perfect health. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures.
Time Frame Baseline, up to Week 8

Outcome Measure Data

Analysis Population Description
All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
Measure Participants 76 38
Mean (95% Confidence Interval) [score on a scale] 0.07 0.03
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 750 Mg-500 mg LY3016859, Placebo
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%-0.01 to 0.10
Parameter Dispersion Type: Value:
Estimation Comments The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.

Adverse Events

Time Frame Baseline through Week 26
Adverse Event Reporting Description All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Arm/Group Title 750 Mg-500 mg LY3016859 Placebo
Arm/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. Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
All Cause Mortality
750 Mg-500 mg LY3016859 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/83 (1.2%) 0/41 (0%)
Serious Adverse Events
750 Mg-500 mg LY3016859 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/83 (3.6%) 2/41 (4.9%)
Gastrointestinal disorders
Nausea 1/83 (1.2%) 1 0/41 (0%) 0
Vomiting 1/83 (1.2%) 1 0/41 (0%) 0
Infections and infestations
Covid-19 pneumonia 1/83 (1.2%) 1 0/41 (0%) 0
Diabetic foot infection 0/83 (0%) 0 1/41 (2.4%) 1
Injury, poisoning and procedural complications
Adverse event following immunisation 0/83 (0%) 0 1/41 (2.4%) 1
Overdose 1/83 (1.2%) 1 0/41 (0%) 0
Psychiatric disorders
Post-traumatic stress disorder 1/83 (1.2%) 1 0/41 (0%) 0
Other (Not Including Serious) Adverse Events
750 Mg-500 mg LY3016859 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 28/83 (33.7%) 12/41 (29.3%)
Gastrointestinal disorders
Abdominal pain upper 0/83 (0%) 0 2/41 (4.9%) 2
Diarrhoea 3/83 (3.6%) 4 0/41 (0%) 0
Nausea 4/83 (4.8%) 4 0/41 (0%) 0
General disorders
Infusion site pain 4/83 (4.8%) 4 0/41 (0%) 0
Xerosis 3/83 (3.6%) 3 0/41 (0%) 0
Infections and infestations
Covid-19 0/83 (0%) 0 3/41 (7.3%) 3
Sinusitis 3/83 (3.6%) 3 0/41 (0%) 0
Investigations
Glomerular filtration rate decreased 0/83 (0%) 0 2/41 (4.9%) 2
Musculoskeletal and connective tissue disorders
Arthralgia 3/83 (3.6%) 3 2/41 (4.9%) 2
Back pain 3/83 (3.6%) 3 0/41 (0%) 0
Muscle spasms 0/83 (0%) 0 2/41 (4.9%) 2
Nervous system disorders
Headache 3/83 (3.6%) 4 1/41 (2.4%) 1
Skin and subcutaneous tissue disorders
Dry skin 3/83 (3.6%) 3 0/41 (0%) 0
Pruritus 4/83 (4.8%) 4 2/41 (4.9%) 2
Rash 6/83 (7.2%) 7 0/41 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Chief Medical Officer
Organization Eli Lilly and Company
Phone 800-545-5979
Email ClinicalTrials.gov@lilly.com
Responsible Party: Eli Lilly and Company ClinicalTrials.gov Identifier: NCT04476108 Other Study ID Numbers:
  • 17535
  • H0P-MC-NP01
First Posted: Jul 17, 2020 Last Update Posted: Aug 3, 2022 Last Verified: Aug 1, 2022 Save

Study Details

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Contacts and Locations More Information Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats More Information

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