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A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05630196
Collaborator
(none)
125
Enrollment
30
Locations
2
Arms
7.8
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 assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). 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
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:
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3857210 for the Treatment of Chronic Low Back Pain
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Aug 2, 2023
Anticipated Study Completion Date :
Aug 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3857210

Participants will receive LY3857210

Drug: LY3857210
Administered orally
Placebo Comparator: Placebo

Participants will receive placebo

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Change from Baseline on the Roland Morris Disability Questionnaire (RMDQ) [Baseline, Up to Week 8]

  2. Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [Baseline, Up to Week 12]

  3. Change from Baseline for Worst Pain Intensity as Measured by NRS [Baseline, Up to Week 8]

  4. Change from Baseline on the Visual Analog Scale (VAS) for Pain [Baseline, Up to Week 8]

  5. Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Baseline, Up to Week 8]

  6. Total Amount of Rescue Medication [Baseline, Up to Week 8]

  7. Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [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 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 a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.

  • Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.

  • Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.

  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

  • Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage.

  • 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.

  • Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.

  • Have history of or current compression fracture.

  • Have had a recent major trauma (within 6 months of baseline).

  • Are pregnant or breastfeeding.

  • Have known history of gastric or duodenal ulcers.

  • Have known history of inflammatory bowel disease (including ulcerative colitis or Crohn's disease).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Synexus- Chandler 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 Don Suffer Clinical Research Building 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 - US 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 LLC 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 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

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05630196
Other Study ID Numbers:
  • 18339
  • H0P-MC-BP05
First Posted:
Nov 29, 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:
No
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Jan 18, 2023