Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)
Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)
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 ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriatic arthritis 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.
Inclusion Criteria:
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:
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.
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