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Tests treatment safety and results for Psoriasis
Official title 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)
ClinicalTrials.gov ID: NCT06857942
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for psoriasis.
Also referred to as LY3298176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example...
- 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...
- 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).
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Fountain Valley, California, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Tampa, Florida, United States
- Wellington, Florida, United States
- Douglasville, Georgia, United States
- Indianapolis, Indiana, United States
- Plainfield, Indiana, United States
- Bowling Green, Kentucky, United States
- Rockville, Maryland, United States
- Brighton, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Bay City, Michigan, United States
- Caledonia, Michigan, United States
- Reno, Nevada, United States
- Portsmouth, New Hampshire, United States
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Fountain Valley, California, United States; Fremont, California, United States; Los Angeles, California, United States; Northridge, California, United States; Hialeah, Florida, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.