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Chronic Pain Master Protocol (CPMP): A Study of LY3526318 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: NCT05080660
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to test safety or efficacy of study drug LY3526318 in participants with osteoarthritis (OA) knee 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 Osteo Arthritis Knee Drug: LY356318 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3526318
LY3526318 administered orally.
Drug: LY356318
Administered orally.

Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally.




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® Pain Subscale

  3. Change from Baseline on the WOMAC® Physical Function Subscale [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the WOMAC® Pain 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 EuroQuality of Life Five Dimensions (5D) Five Level (5L) 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 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 or the duration of the study.
  • Are at 40 years old or older at the time consent is signed.
  • 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 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 fibromyalgia
  • 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 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, pseudo gout).
  • Have pain or functional impairment due to ipsilateral hip osteoarthritis.
  • Are pregnant or breastfeeding.

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): NCT05080660


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 13176154559 ClinicalTrials.gov@lilly.com

Locations
Show Show 37 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: NCT05080660    
Other Study ID Numbers: 17592
H0P-MC-OA02 ( Other Identifier: Eli Lilly and Company )
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
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
Osteoarthritis, Knee
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations