A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
- Registration Number
- NCT06857942
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.
The study will last up to 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)
- Have body mass index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to <30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular diseases).
- Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide.
- Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening).
- Have currently received ixekizumab for more than 4 months or less than 2 months.
- Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.
- Are currently enrolled in any other clinical study.
Other exclusions
- Have a known hypersensitivity to tirzepatide or to any of its component.
- Have a personal or family history of medullary thyroid cancer.
- Have multiple endocrine neoplasia type 2.
- Have type I diabetes mellitus.
- Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
- Have a history of ketoacidosis or hyperosmolar state/coma.
- Have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening.
- Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) 12 months The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.
Percentage of Participants Achieving at least 10% Weight Reduction 12 months Percentage of participants achieving at least 10% weight reduction.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target] Month 6 and Month 12 The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area.
Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal) Month 6 and Month 12 The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1) Month 6 and Month 12 The sPGA is an investigator-administered multi-item scale. It determines the participant's psoriasis (PsO) lesions, overall, at a given time point. Overall lesions are graded for plaque elevation, scaling, and erythema, on a range of clear (0), almost clear (1), mild (2), moderate (3), and severe (4).
Mean Percent Change of Weight from Baseline Baseline, Month 6 and Baseline, Month 12 Mean percent change of weight from baseline.
Percentage of Participants Achieving DLQI ≤5 Month 6 and Month 12 The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.
Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2 Month 6 and Month 12 The PatGA of Psoriasis is a patient-reported single-item scale. Patient Global Assessments allow for an overall evaluation of disease severity or global impact of the disease from the patient's perspective. Participants are asked to rank the severity of their PsO "today" by selecting a number on a 0-to-5 numeric rating scale, with 0 indicating clear/no PsO and 5 indicating severe PsO.
Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction Month 6 and Month 12 The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.
Related Research Topics
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Trial Locations
- Locations (38)
NorCal Clinical Research
🇺🇸Rocklin, California, United States
Integrative Skin Science and Research - Location 3
🇺🇸Sacramento, California, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
First OC Dermatology Research Inc
🇺🇸Fountain Valley, California, United States
Northridge Clinical Trials
🇺🇸Northridge, California, United States
Alliance for Multispecialty Research, LLC
🇺🇸Fort Myers, Florida, United States
NeoClinical Research
🇺🇸Hialeah, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
🇺🇸Tampa, Florida, United States
Southeast Research Specialists
🇺🇸Douglasville, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
Equity Medical - Bowling Green
🇺🇸Bowling Green, Kentucky, United States
Dermatology and Skin Cancer Specialists, LLC
🇺🇸Rockville, Maryland, United States
David Fivenson, MD, PLC
🇺🇸Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
The Derm Institute of West Michigan
🇺🇸Caledonia, Michigan, United States
Skin Cancer and Dermatology Institute - Reno
🇺🇸Reno, Nevada, United States
Stracskin
🇺🇸Portsmouth, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Care Access - Hoboken
🇺🇸Hoboken, New Jersey, United States
Equity Medical
🇺🇸New York, New York, United States
Onsite Clinical Solutions - Huntersville
🇺🇸Huntersville, North Carolina, United States
Optima Research - Boardman
🇺🇸Boardman, Ohio, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
🇺🇸Plymouth Meeting, Pennsylvania, United States
Columbia Dermatology & Aesthetics
🇺🇸Columbia, South Carolina, United States
DelRicht Research - Thompson's Station
🇺🇸Smyrna, Tennessee, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Modern Research Associates, PLLC
🇺🇸Dallas, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Bellevue Dermatology Clinic
🇺🇸Bellevue, Washington, United States
Dermatology of Seattle
🇺🇸Burien, Washington, United States
Office of Dr. Alma M. Cruz
🇵🇷Carolina, Puerto Rico