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

Chronic Low-back Pain Clinical Trial

Official title:

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3857210 for the Treatment of Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630196
• Other study ID #: 18339
• Secondary ID: H0P-MC-BP05
• Status: Completed
• Phase: Phase 2
• Start date: December 8, 2022
• Est. completion date: June 15, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 15, 2023
• Est. primary completion date: June 9, 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 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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

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	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- Chandler	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 LLC	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 Don Suffer Clinical Research Building	Miami	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Synexus - US	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 on the Roland Morris Disability Questionnaire (RMDQ)		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 12
Secondary	Change from Baseline for Worst Pain Intensity as Measured by NRS		Baseline, Up to Week 8
Secondary	Change from Baseline on the Visual Analog Scale (VAS) for Pain		Baseline, Up to Week 8
Secondary	Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)		Baseline, Up to Week 8
Secondary	Total Amount of Rescue Medication		Baseline, Up to Week 8
Secondary	Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L)		Baseline, Up to Week 8