Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Description

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Conditions

Psoriasis, Obesity

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Study Overview

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Study Details

Study overview

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Condition
Psoriasis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology, Birmingham, Alabama, United States, 35203

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Scottsdale

Scottsdale Clinical Trials, Scottsdale, Arizona, United States, 85260

Yuma

Yuma Clinical Trials, Yuma, Arizona, United States, 85365

Fort Smith

Johnson Dermatology, Fort Smith, Arkansas, United States, 72916

Encinitas

California Dermatology & Clinical Research Institute, Encinitas, California, United States, 92024

Fountain Valley

First OC Dermatology Research Inc, Fountain Valley, California, United States, 92708

Laguna Niguel

Avance Clinical Trials, Laguna Niguel, California, United States, 92677

Los Angeles

Metropolis Dermatology, Los Angeles, California, United States, 90017

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
  • * Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
  • * Have ≥10% body surface area (BSA) involvement.
  • * Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).
  • * Have Type 1 Diabetes Mellitus (T1DM).
  • * Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
  • * Have a prior or planned surgical treatment for obesity.
  • * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
  • * Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
  • * Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:
  • * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
  • * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
  • * Have serious disorder or illness other than PsO.
  • * Have a history of chronic or acute pancreatitis.
  • * Have any prior use of ixekizumab or tirzepatide.
  • * Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-05