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Recruiting NCT06857942

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)

Phase IV Interventional Psoriasis Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide.
Who it may be relevant to
Registry conditions: Psoriasis, Overweight or Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tirzepatide
    Administered SC

Primary outcome measures

  • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) [Time frame: 12 months]
  • Percentage of Participants Achieving at least 10% Weight Reduction [Time frame: 12 months]
Secondary outcome measures (7)
  • Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target] [Time frame: Month 6 and Month 12]
  • Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal) [Time frame: Month 6 and Month 12]
  • Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1) [Time frame: Month 6 and Month 12]
  • Percentage of Participants Achieving DLQI ≤5 [Time frame: Month 6 and Month 12]
  • Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2 [Time frame: Month 6 and Month 12]
  • Mean Percent Change of Weight from Baseline [Time frame: Baseline, Month 6 and Baseline, Month 12]
  • Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction [Time frame: Month 6 and Month 12]

Eligibility criteria

Inclusion 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, 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 40 centers
  • 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
  • … and 32 more centers

Identifiers

NCT: NCT06857942 · 27319 · I1F-MC-RHDD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗