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A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (OA05)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3857210
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 presence of index knee pain for >12 weeks at screening. Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee. 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. 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 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. Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare. Have presence of surgical hardware or other foreign body in the index knee. Have an unstable index joint (such as a torn anterior cruciate ligament). Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period. Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee. Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis. Have clinical signs and symptoms of active knee infection or crystal disease of the index knee. Have a history of infection in the index joint. Have a history of arthritis due to crystals (e.g., gout, pseudogout). Have pain or functional impairment due to ipsilateral hip osteoarthritis. Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator. Have clinically significant active thyroid disease, including Hashimoto's thyroiditis. Are taking metformin therapy. Are pregnant or breastfeeding. Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.

Sites / Locations

  • Synexus Clinical Research US, Inc.
  • Arizona Research Center
  • Artemis Institute for Clinical Research
  • Artemis Institute for Clinical Research
  • CMR of Greater New Haven, LLC
  • Accel Research Sites- Clinical Research Unit
  • Suncoast Research Group
  • University of Miami
  • New Horizon Research Center
  • Renstar Medical Research
  • Synexus Clinical Research US, Inc - Orlando
  • Synexus Clinical Research US, Inc.
  • North Georgia Clinical Research
  • Rocky Mountain Clinical Research
  • Northwestern University
  • Boston Clinical Trials
  • ActivMed Practices and Research
  • MedVadis Research Corporation
  • Great Lakes Research Group, Inc.
  • StudyMetrix Research
  • Clinvest Research LLC
  • Lillestol Research
  • META Medical Research Institute
  • Altoona Center For Clinical Research
  • FutureSearch Trials of Neurology
  • Synexus Clinical Research US, Inc.
  • Northwest Clinical Research Center
  • Rainier Clinical Research Center
  • Ponce Medical School Foundation Inc.
  • Latin Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3857210

Placebo

Arm Description

LY3857210 will be given orally

Placebo will be given orally

Outcomes

Primary Outcome Measures

Change from Baseline for Average Pain Intensity as measured by the Numeric Rating Scale (NRS)

Secondary Outcome Measures

Change from Baseline for Disease State Assessment (DSA)
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
Percentage of Participants with a Pain Reduction from Baseline Greater than or equal to 30%, 50%, and 70% as Measured by the Average and Worst Pain Responses on the NRS
Percentage of Participants with at least 2-point Reduction from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Time to First Pain Reduction of at Least 30%, 50%, and 70% from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Time to First Pain Reduction of at least 2-point from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Change from Baseline for on the Visual Analog Scale (VAS) for Pain
Percentage of Participants with Pain Reduction from Baseline Greater than or equal to 30%, 50%, and 70% as Measured by VAS
Change from Baseline for on the Sleep Scale from the Medical Outcomes Study (MOS) Sleep Scale
Percentage of Participants with Reduction from Baseline Greater Than or Equal to 30%, 50%, and 70% on the Physical Functioning Measures as described in the DSA
Summary of Frequency, Timing, and Amount of Rescue Medication used during the Treatment Phase
Change from Baseline for Emotional Functioning as measured by the EuroQol-5D-5-Level Questionnaire (EQ-5D-5L)

Full Information

First Posted
November 11, 2022
Last Updated
July 11, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05620563
Brief Title
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain
Acronym
OA05
Official Title
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3857210
Arm Type
Experimental
Arm Description
LY3857210 will be given orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given orally
Intervention Type
Drug
Intervention Name(s)
LY3857210
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change from Baseline for Average Pain Intensity as measured by the Numeric Rating Scale (NRS)
Time Frame
Baseline, Up to Week 8
Secondary Outcome Measure Information:
Title
Change from Baseline for Disease State Assessment (DSA)
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline for Overall improvement as Measured by Patient's Global Impression of Change
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline for Worst Pain Intensity as Measured by NRS
Time Frame
Baseline, Up to Week 8
Title
Percentage of Participants with a Pain Reduction from Baseline Greater than or equal to 30%, 50%, and 70% as Measured by the Average and Worst Pain Responses on the NRS
Time Frame
Baseline to Week 8
Title
Percentage of Participants with at least 2-point Reduction from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Time Frame
Baseline to Week 8
Title
Time to First Pain Reduction of at Least 30%, 50%, and 70% from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Time Frame
Baseline to Week 8
Title
Time to First Pain Reduction of at least 2-point from Baseline as Measured by the Average and Worst Pain Responses on the NRS
Time Frame
Baseline to Week 8
Title
Change from Baseline for on the Visual Analog Scale (VAS) for Pain
Time Frame
Baseline, Up to Week 8
Title
Percentage of Participants with Pain Reduction from Baseline Greater than or equal to 30%, 50%, and 70% as Measured by VAS
Time Frame
Baseline to Week 8
Title
Change from Baseline for on the Sleep Scale from the Medical Outcomes Study (MOS) Sleep Scale
Time Frame
Baseline, Up to Week 8
Title
Percentage of Participants with Reduction from Baseline Greater Than or Equal to 30%, 50%, and 70% on the Physical Functioning Measures as described in the DSA
Time Frame
Baseline to Week 8
Title
Summary of Frequency, Timing, and Amount of Rescue Medication used during the Treatment Phase
Time Frame
Baseline Through Week 8
Title
Change from Baseline for Emotional Functioning as measured by the EuroQol-5D-5-Level Questionnaire (EQ-5D-5L)
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 presence of index knee pain for >12 weeks at screening. Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee. 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. 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 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. Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare. Have presence of surgical hardware or other foreign body in the index knee. Have an unstable index joint (such as a torn anterior cruciate ligament). Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period. Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee. Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis. Have clinical signs and symptoms of active knee infection or crystal disease of the index knee. Have a history of infection in the index joint. Have a history of arthritis due to crystals (e.g., gout, pseudogout). Have pain or functional impairment due to ipsilateral hip osteoarthritis. Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator. Have clinically significant active thyroid disease, including Hashimoto's thyroiditis. Are taking metformin therapy. Are pregnant or breastfeeding. Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Synexus Clinical Research US, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
CMR of Greater New Haven, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Synexus Clinical Research US, Inc - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
META Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/368103
Description
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (OA05)

Learn more about this trial

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain

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