Status:
ACTIVE_NOT_RECRUITING
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Psoriasis
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 conditi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06588283
Start Date
September 30 2024
End Date
May 1 2026
Last Update
October 16 2025
Active Locations (72)
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1
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama, United States, 35203
2
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
3
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
4
Yuma Clinical Trials
Yuma, Arizona, United States, 85365