Status:
ACTIVE_NOT_RECRUITING
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Psoriatic Arthritis
Obesity
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixeki...
Eligibility Criteria
Inclusion
- Have signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
- Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
- 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 a serious disorder or illness other than PsA.
- Have a history of chronic or acute pancreatitis.
- Have any prior use of ixekizumab or tirzepatide.
- Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
- 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 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06588296
Start Date
September 24 2024
End Date
April 1 2026
Last Update
November 24 2025
Active Locations (86)
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1
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States, 85392
2
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona, United States, 85225
3
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, United States, 86001
4
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona, United States, 85297