Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT06588296
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 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.
Interventions
Name:
Ixekizumab
Type:
DRUG
Description:
Administered SC
Name:
Tirzepatide
Type:
DRUG
Description:
Administered SC
Primary Outcomes
Measure:
Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
TimeFrame:
Baseline up to Week 36
Description:
ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:
1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \_NRS)
3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Trial Information
NCT ID
NCT06588296
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Eli Lilly and Company
Last Updated
December 15, 2025