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

Launched by ELI LILLY AND COMPANY · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, ixekizumab and tirzepatide, when given together to adults who have moderate to severe plaque psoriasis and are also overweight or obese. The goal is to see if using both medications together can help improve psoriasis symptoms and lead to weight loss, compared to using just ixekizumab alone.

To participate in this study, you should be an adult with a diagnosis of moderate to severe plaque psoriasis for at least six months and have a certain level of skin involvement and body mass index (BMI). The trial involves up to 12 visits over approximately 61 weeks, including initial screenings, a treatment period, and follow-up after treatment. It’s important to note that some individuals, such as those with certain types of diabetes or specific medical histories, may not be eligible to participate. This study is currently recruiting participants, and it's a great opportunity to contribute to research that could help improve treatments for psoriasis and obesity.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• Exclusion Criteria:
• • Medical Conditions
• • 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.