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NCT06588296 | NOT YET RECRUITING | Psoriatic Arthritis

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
Sponsor:

Eli Lilly and Company

Brief Summary:

The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight 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.

Condition or disease

Psoriatic Arthritis

Obesity

Intervention/treatment

Ixekizumab

Tirzepatide

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2024-09
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 a body mass index (BMI) greater or equal to ≥27 kilograms per meter squared (kg/m²).
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 or cervical carcinoma in situ.
  • * 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.
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Location Details

NCT06588296

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Montana

Logan Health Research

Kalispell, Montana, United States, 59901