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

Osteoarthritis, Knee Clinical Trial

— OA05  

Official title:

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620563
• Other study ID #: 18338
• Secondary ID: H0P-MC-OA05
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2022
• Est. completion date: June 12, 2023

Study information

• Verified date: July 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 12, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• LY3857210
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Synexus Clinical Research US, Inc.	Chandler	Arizona
United States	Northwestern University	Chicago	Illinois
United States	META Medical Research Institute	Dayton	Ohio
United States	Accel Research Sites- Clinical Research Unit	DeLand	Florida
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Lillestol Research	Fargo	North Dakota
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Synexus Clinical Research US, Inc - Orlando	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc.	Pinellas Park	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Artemis Institute for Clinical Research	Riverside	California
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline for Average Pain Intensity as measured by the Numeric Rating Scale (NRS)		Baseline, Up to Week 8
Secondary	Change from Baseline for Disease State Assessment (DSA)		Baseline, Up to Week 8
Secondary	Change from Baseline for Overall improvement as Measured by Patient's Global Impression of Change		Baseline, Up to Week 8
Secondary	Change from Baseline for Worst Pain Intensity as Measured by NRS		Baseline, Up to Week 8
Secondary	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		Baseline to Week 8
Secondary	Percentage of Participants with at least 2-point Reduction from Baseline as Measured by the Average and Worst Pain Responses on the NRS		Baseline to Week 8
Secondary	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		Baseline to Week 8
Secondary	Time to First Pain Reduction of at least 2-point from Baseline as Measured by the Average and Worst Pain Responses on the NRS		Baseline to Week 8
Secondary	Change from Baseline for on the Visual Analog Scale (VAS) for Pain		Baseline, Up to Week 8
Secondary	Percentage of Participants with Pain Reduction from Baseline Greater than or equal to 30%, 50%, and 70% as Measured by VAS		Baseline to Week 8
Secondary	Change from Baseline for on the Sleep Scale from the Medical Outcomes Study (MOS) Sleep Scale		Baseline, Up to Week 8
Secondary	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		Baseline to Week 8
Secondary	Summary of Frequency, Timing, and Amount of Rescue Medication used during the Treatment Phase		Baseline Through Week 8
Secondary	Change from Baseline for Emotional Functioning as measured by the EuroQol-5D-5-Level Questionnaire (EQ-5D-5L)		Baseline to Week 8

External Links

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