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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05620563

Collaborator

(none)

125

Enrollment

Locations

Arms

8.5

Anticipated Duration (Months)

4.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: LY3852710 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 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 :

Nov 22, 2022

Anticipated Primary Completion Date :

Jul 24, 2023

Anticipated Study Completion Date :

Aug 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3857210 LY3857210 will be given orally	Drug: LY3852710 Administered orally
Placebo Comparator: Placebo Placebo will be given orally	Drug: Placebo Administered orally

Arm

Intervention/Treatment

Experimental: LY3857210

LY3857210 will be given orally

Drug: LY3852710

Administered orally

Placebo Comparator: Placebo

Placebo will be given orally

Drug: Placebo

Administered orally

Outcome Measures

Primary Outcome Measures

Change from Baseline for Average Pain Intensity as measured by the Numeric Rating Scale (NRS) [Baseline, Up to Week 8]

Secondary Outcome Measures

Change from Baseline for Disease State Assessment (DSA) [Baseline, Up to Week 8]
Change from Baseline for Overall improvement as Measured by Patient's Global Impression of Change [Baseline, Up to Week 8]
Change from Baseline for Worst Pain Intensity as Measured by NRS [Baseline, Up to Week 8]
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]
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]
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]
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]
Change from Baseline for on the Visual Analog Scale (VAS) for Pain [Baseline, Up to Week 8]
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]
Change from Baseline for on the Sleep Scale from the Medical Outcomes Study (MOS) Sleep Scale [Baseline, Up to Week 8]
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]
Summary of Frequency, Timing, and Amount of Rescue Medication used during the Treatment Phase [Baseline Through Week 8]
Change from Baseline for Emotional Functioning as measured by the EuroQol-5D-5-Level Questionnaire (EQ-5D-5L) [Baseline to Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synexus Clinical Research US, Inc.	Chandler	Arizona	United States	85224
2	Arizona Research Center	Phoenix	Arizona	United States	85053
3	Artemis Institute for Clinical Research	Riverside	California	United States	92503
4	Artemis Institute for Clinical Research	San Diego	California	United States	92103
5	CMR of Greater New Haven, LLC	Hamden	Connecticut	United States	06517
6	Accel Research Sites- Clinical Research Unit	DeLand	Florida	United States	32720
7	Suncoast Research Group	Miami	Florida	United States	33135
8	University of Miami	Miami	Florida	United States	33136
9	New Horizon Research Center	Miami	Florida	United States	33165
10	Renstar Medical Research	Ocala	Florida	United States	34470
11	Synexus Clinical Research US, Inc - Orlando	Orlando	Florida	United States	32806
12	Synexus Clinical Research US, Inc.	Pinellas Park	Florida	United States	33781
13	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
14	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
15	Northwestern University	Chicago	Illinois	United States	60611
16	Boston Clinical Trials	Boston	Massachusetts	United States	02131
17	ActivMed Practices and Research	Methuen	Massachusetts	United States	01844
18	MedVadis Research Corporation	Waltham	Massachusetts	United States	02451
19	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
20	StudyMetrix Research	Saint Peters	Missouri	United States	63303
21	Clinvest Research LLC	Springfield	Missouri	United States	65807
22	Lillestol Research	Fargo	North Dakota	United States	58104
23	META Medical Research Institute	Dayton	Ohio	United States	45432
24	Altoona Center For Clinical Research	Duncansville	Pennsylvania	United States	16635
25	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
26	Synexus Clinical Research US, Inc.	San Antonio	Texas	United States	78229
27	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
28	Rainier Clinical Research Center	Renton	Washington	United States	98057
29	Ponce Medical School Foundation Inc.	Ponce		Puerto Rico	00716
30	Latin Clinical Trial Center	San Juan		Puerto Rico	00909

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05620563

Other Study ID Numbers:

18338
H0P-MC-OA05

First Posted:

Nov 17, 2022

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Chronic Pain

Study Results

No Results Posted as of Jan 18, 2023