Ixekizumab + Tirzepatide for Psoriatic Arthritis
(TOGETHER-PsA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, ixekizumab and tirzepatide, to determine their effectiveness in helping people with psoriatic arthritis manage symptoms and lose weight. Ixekizumab treats inflammatory conditions, while tirzepatide aids in weight loss. The trial aims to discover if combining both treatments is more effective than using ixekizumab alone. It seeks participants who have had psoriatic arthritis for at least six months and are overweight or have obesity. Participants should also have at least one weight-related condition, such as high blood pressure or type 2 diabetes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have tested ixekizumab in many people with psoriatic arthritis, generally showing a good safety record. A large study of 1,401 patients found that serious heart problems were rare over three years. However, some participants experienced more infections than those who took a placebo.
Tirzepatide is often used for weight management and diabetes and has received FDA approval for type 2 diabetes. This approval suggests it is generally safe, though some people might experience side effects like nausea or diarrhea.
Research on using ixekizumab and tirzepatide together is ongoing. Specific data about side effects from their combined use is not yet available. However, based on known information about each drug individually, researchers hope they remain safe when used together.
Everyone's experience is unique, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Ixekizumab combined with Tirzepatide for treating Psoriatic Arthritis because it offers a novel approach by combining two different mechanisms. Ixekizumab, an IL-17A inhibitor, targets specific inflammatory pathways, while Tirzepatide, traditionally used for diabetes, acts as a dual GIP and GLP-1 receptor agonist, potentially improving metabolic profiles and inflammation. This combination could offer enhanced efficacy in reducing joint pain and skin symptoms compared to standard treatments like TNF inhibitors or methotrexate, providing a dual-action strategy that addresses both inflammation and metabolic dysfunction.
What evidence suggests that this trial's treatments could be effective for psoriatic arthritis?
Research has shown that ixekizumab, one of the treatments in this trial, effectively treats psoriatic arthritis. In one study, 47% of patients experienced significant improvement in joint symptoms after one year. Another study found that ixekizumab helped maintain low disease activity for up to 24 months. This trial will also test a combination of ixekizumab with tirzepatide. Early findings suggest that this combination might reduce arthritis symptoms and aid weight loss in overweight patients, potentially becoming a new standard for treating inflammatory conditions in people with obesity.16789
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with psoriatic arthritis who are also overweight or obese. Participants will visit the study site up to 12 times over a maximum of 61 weeks, including different phases like screening and follow-up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Treatment
Participants receive ixekizumab and tirzepatide concomitantly administered to improve psoriatic arthritis and achieve weight reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ixekizumab
- Tirzepatide
Ixekizumab is already approved in United States, European Union for the following indications:
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Active ankylosing spondylitis
- Active non-radiographic axial spondyloarthritis
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Active ankylosing spondylitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University