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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456686
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study is being done to test the safety and efficacy of LY3016859 for the treatment of osteoarthritis 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
Osteoarthritis Drug: LY3016859 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 Osteoarthritis
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 5, 2021
Estimated Study Completion Date : March 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: LY3016859
LY3016859 given intravenously (IV).
Drug: LY3016859
LY3016859 given IV.

Placebo Comparator: Placebo
Placebo given IV.
Drug: Placebo
Placebo given IV.




Primary Outcome Measures :
  1. Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline in Average Pain Intensity as Measured by the NRS


Secondary Outcome Measures :
  1. Change from Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the WOMAC® Pain Subscale

  2. Change from Baseline on the WOMAC® Stiffness Subscale [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the WOMAC® Stiffness Subscale

  3. Change from Baseline on the WOMAC® Physical Function Subscale [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the WOMAC® Physical Function Subscale

  4. 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

  5. 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

  6. 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

  7. 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

  8. Total Amount of Rescue Medication [ Time Frame: Baseline up to Week 8 ]
    Total Amount of Rescue Medication

  9. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  • 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.
  • 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 ipsilateral hip osteoarthritis.
  • Have had an intra-articular injection of hyaluronic acid within 24 weeks of screening.
  • 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 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 angioedema or common variable immune deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456686


Contacts
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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

Locations
Show Show 35 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04456686    
Other Study ID Numbers: 17513
H0P-MC-OA01 ( Other Identifier: Eli Lilly and Company )
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases