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)

Официальное название

A Phase 4, Prospective, Open-Label, Single Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight in Clinical Practice

Обзор

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.

Вмешательства

• Препарат Tirzepatide
  Administered SC

Первичные конечные точки

• Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) [Срок оценки: 12 months]
• Percentage of Participants Achieving at least 10% Weight Reduction [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target] [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal) [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1) [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving DLQI ≤5 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2 [Срок оценки: Month 6 and Month 12]
• Mean Percent Change of Weight from Baseline [Срок оценки: Baseline, Month 6 and Baseline, Month 12]
• Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction [Срок оценки: Month 6 and Month 12]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 40 центров

• Medical Dermatology Specialists — Phoenix
• First OC Dermatology Research Inc — Fountain Valley
• Center For Dermatology Clinical Research, Inc. — Fremont
• Metropolis Dermatology — Los Angeles
• Northridge Clinical Trials — Northridge
• NeoClinical Research — Hialeah
• Skin Care Research — Hollywood
• Encore Medical Research — Hollywood
• … и ещё 32 центра

Идентификаторы

NCT: NCT06857942 · 27319 · I1F-MC-RHDD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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