CPMP: A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05986292
• Collaborator: (none)
• Enrollment: 10,000
• Locations: 39
• Arms: 12
• Anticipated Duration (Months): 86.8
• Patients Per Site: 256.4
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee; Diabetic Neuropathic Pain; Chronic Low-back Pain	Drug: LY3016859 ISA; Drug: LY3556050 ISA; Drug: LY3526318 ISA; Drug: LY3857210 ISA; Drug: Placebo Oral; Drug: Placebo	Phase 2

Detailed Description

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• 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: Jan 30, 2020
• Anticipated Primary Completion Date: Apr 25, 2027
• Anticipated Study Completion Date: Apr 25, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3016859 Osteoarthritis ISA Participants are randomized to receive either active LY3016859 or matching placebo	Drug: LY3016859 ISA; Administered intravenously (IV); Drug: Placebo; Placebo administered IV
Experimental: LY3016859 Diabetic Neuropathic Pain ISA Participants are randomized to receive either active LY3016859 or matching placebo	Drug: LY3016859 ISA; Administered intravenously (IV); Drug: Placebo; Placebo administered IV
Experimental: LY3016859 Chronic Back Pain ISA Participants are randomized to receive either active LY3016859 or matching placebo	Drug: LY3016859 ISA; Administered intravenously (IV); Drug: Placebo; Placebo administered IV
Experimental: LY3556050 Osteoarthritis ISA Participants are randomized to receive either active LY3556050 or matching placebo	Drug: LY3556050 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3556050 Diabetic Neuropathic Pain ISA Participants are randomized to receive either active LY3556050 or matching placebo	Drug: LY3556050 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3556050 Chronic Back Pain ISA Participants are randomized to receive either active LY3556050 or matching placebo	Drug: LY3556050 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3526318 Osteoarthritis ISA Participants are randomized to receive either active LY3526318 or matching placebo	Drug: LY3526318 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3526318 Diabetic Neuropathic Pain ISA Participants are randomized to receive either active LY3526318 or matching placebo	Drug: LY3526318 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3526318 Chronic Back Pain ISA Participants are randomized to receive either active LY3526318 or matching placebo	Drug: LY3526318 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3857210 Osteoarthritis ISA Participants are randomized to receive either active LY3857210 or matching placebo	Drug: LY3857210 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3857210 Diabetic Neuropathic Pain ISA Participants are randomized to receive either active LY3857210 or matching placebo	Drug: LY3857210 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally
Experimental: LY3857210 Chronic Back Pain ISA Participants are randomized to receive either active LY3857210 or matching placebo	Drug: LY3857210 ISA; Administered orally; Drug: Placebo Oral; Placebo administered orally

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Were Allocated to Each ISA [Baseline, Up to Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• have a visual analog scale (VAS) pain value >40 and <95 at screening and prerandomization 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 kilogram/square meter (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, except rescue medication for the duration of the study

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 fibromyalgia

• have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

• 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

• have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMR of Greater New Haven, LLC	Hamden	Connecticut	United States	06517
2	Encore Research Group- Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
3	Suncoast Research Group	Miami	Florida	United States	33135
4	University of Miami Don Suffer Clinical Research Building	Miami	Florida	United States	33136
5	New Horizon Research Center	Miami	Florida	United States	33165
6	Renstar Medical Research	Ocala	Florida	United States	34470
7	Synexus Clinical Research US, Inc.	Orlando	Florida	United States	32806
8	Synexus Clinical Research - St. Petersburg	Pinellas Park	Florida	United States	33781
9	Martin E. Hale M.D., P.A.	Plantation	Florida	United States	33317
10	Synexus Clinical Research US, Inc.	The Villages	Florida	United States	32162
11	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
12	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
13	Synexus Clinical Research	Chicago	Illinois	United States	60602
14	Physical Medicine and Rehabilitation	Chicago	Illinois	United States	60611
15	Diabetes Research	Skokie	Illinois	United States	60077
16	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas	United States	66606
17	Boston Clinical Trials	Boston	Massachusetts	United States	02131
18	ActivMed Practices and Research	Methuen	Massachusetts	United States	01844
19	MedVadis Research Corporation	Waltham	Massachusetts	United States	02451
20	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
21	Research	Saint Peters	Missouri	United States	63303
22	Clinvest Research LLC	Springfield	Missouri	United States	65807
23	Synexus Clinical Research US, Inc.	Omaha	Nebraska	United States	68144
24	PharmQuest Life Sciences, LLC	Greensboro	North Carolina	United States	27408
25	Lillestol Research	Fargo	North Dakota	United States	58104
26	Synexus - Cincinnati	Cincinnati	Ohio	United States	45236
27	Rapid Medical Research	Cleveland	Ohio	United States	44122
28	Aventiv Research Inc	Columbus	Ohio	United States	43213
29	META Medical Research Institute	Dayton	Ohio	United States	45432
30	Clinical Research Center of Reading,LLC	Wyomissing	Pennsylvania	United States	19610
31	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
32	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
33	Synexus	Dallas	Texas	United States	75234
34	Cedar Health Research	Dallas	Texas	United States	75251
35	Synexus Clinical Research US, Inc.	San Antonio	Texas	United States	78229
36	SYNEXUS	Murray	Utah	United States	84123
37	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
38	Rainier Clinical Research Center	Renton	Washington	United States	98057
39	Ponce Medical School Foundation Inc.	Ponce		Puerto Rico	00716

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)

• Study Protocol: CPMP 05 Protocol Master (a) - Dec 11, 2020

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05986292
• Other Study ID Numbers: 17511; H0P-MC-CPMP
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 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: No
• Additional relevant MeSH terms: Osteoarthritis, Knee; Neuralgia; Low Back Pain; Chronic Pain

Study Results

No Results Posted as of Aug 16, 2023