Clinical trial NCT04627038: Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis
Official title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3556050 for the Treatment of Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to test the safety and efficacy of LY3556050 for the treatment of osteoarthritis 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.


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.

Primary outcomes:
measure: Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
timeFrame: Baseline, Week 8
measure: Change From Baseline on the WOMAC® Stiffness Subscale
timeFrame: Baseline, Week 8
measure: Change From Baseline on the WOMAC® Physical Function Subscale
timeFrame: Baseline, Week 8
measure: Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
timeFrame: Baseline, Week 8
measure: Change From Baseline for Worst Pain Intensity as Measured by NRS
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
timeFrame: Baseline, Week 8
measure: Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
timeFrame: Week 8
measure: Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon Williamson Clinic
state: Alabama
city: Chandler
country: United States
facility: Synexus- Chandler
state: Arizona
city: Glendale
country: United States
facility: Synexus Clinical Research - Glendale
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research - Clinical Research Consortium
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: University of Miami Don Suffer Clinical Research Building
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc - Orlando
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research - St. Petersburg
state: Florida
city: Plantation
country: United States
facility: Martin E. Hale M.D., P.A.
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Chicago
country: United States
facility: Synexus Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading,LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: San Antonio
country: United States
facility: Synexus - US
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: