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)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Have a known hypersensitivity to tirzepatide or to any of its component.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

    Administered SC

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1)

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.

Time frame
12 months
2

Percentage of Participants Achieving at least 10% Weight Reduction

Percentage of participants achieving at least 10% weight reduction.

Time frame
12 months

Secondary outcomes

1

Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target]

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.

Time frame
Month 6 and Month 12
2

Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal)

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.

Time frame
Month 6 and Month 12
3

Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1)

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).

Time frame
Month 6 and Month 12
4

Percentage of Participants Achieving DLQI ≤5

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.

Time frame
Month 6 and Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.