Ixekizumab + Tirzepatide for Psoriatic Arthritis

(TOGETHER-PsA Trial)

Not currently recruiting at 95 trial locations
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Alan Kivitz profile photo
Overseen ByAlan Kivitz
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

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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

I have active Psoriatic Arthritis with at least 3 tender and 3 swollen joints.
Have a body mass index (BMI) greater or equal to ≥27 kilograms per meter squared (kg/m²)
I have been diagnosed with Psoriatic Arthritis for at least 6 months.

Exclusion Criteria

I have used ixekizumab or tirzepatide before.
I had a bad reaction or no improvement with IL-17i or GLP-1 drugs.
I have had or am planning to have surgery for weight loss.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Open-label Treatment

Participants receive ixekizumab and tirzepatide concomitantly administered to improve psoriatic arthritis and achieve weight reduction

36 weeks
Up to 12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 21 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ixekizumab
  • Tirzepatide
Trial Overview The trial tests if ixekizumab combined with tirzepatide helps improve psoriatic arthritis symptoms and aids in weight loss better than ixekizumab alone in participants with both conditions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Ixekizumab and TirzepatideExperimental Treatment2 Interventions
Group II: IxekizumabExperimental Treatment1 Intervention

Ixekizumab is already approved in United States, European Union for the following indications:

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Approved in United States as Taltz for:
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Approved in European Union as Taltz for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a clinical trial involving biological disease-modifying antirheumatic drug-naïve patients with active psoriatic arthritis, ixekizumab (IXE) was found to be superior to adalimumab (ADA) in achieving significant improvements in both joint and skin disease at week 24, with 36% of IXE patients achieving the primary endpoint compared to 28% of ADA patients.
IXE also demonstrated a better safety profile, with serious adverse events reported in 3.5% of IXE patients compared to 8.5% in ADA patients, indicating that IXE may be a safer option for patients with inadequate response to conventional treatments.
A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial.Mease, PJ., Smolen, JS., Behrens, F., et al.[2020]
Ixekizumab is a humanized monoclonal antibody specifically designed to inhibit interleukin-17A (IL-17A), a key cytokine involved in inflammatory conditions, making it a targeted treatment for plaque psoriasis.
The approval of ixekizumab in the USA marks a significant milestone in its development, highlighting its efficacy in managing plaque psoriasis by reducing inflammation associated with the condition.
Ixekizumab: First Global Approval.Markham, A.[2018]
In a study of 12 Japanese patients with generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP), ixekizumab demonstrated efficacy, with 57% of GPP patients and 20% of EP patients achieving 'resolved' or 'improved' status by Week 12.
The treatment was found to be safe, with only one non-drug related serious adverse event reported and no adverse events from Week 12 to Week 20 in GPP patients, indicating a favorable safety profile for continuous dosing.
Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis.Morita, A., Okubo, Y., Morisaki, Y., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38814433/
Ixekizumab Demonstrates Rapid and Consistent Efficacy ...More than one-third of IXE-treated patients achieved ACR20 at week 4, or ACR50 at week 24, with no significant differences according to psoriasis severity at ...
Efficacy and Safety in PsA Treatment | Taltz® (ixekizumab)ACR50 results were 47% at week 52, 46% at week 108, and 40% at week 156. ACR70 results were 29% at week 52, 23% at week 108, and 23% at week 156. After week 24, ...
Effectiveness of ixekizumab in 709 real-world patients with ...Outcomes were 6-, 12- and 24-month retention rates and low disease activity (LDA)/remission after 6 months (axSpA: Axial Spondyloarthritis ...
Comparative Analysis of Ixekizumab Effectiveness with and ...Among anti-IL-17 agents, ixekizumab showed promising results with a 4-year drug survival rate of 82.6%, second only to risankizumab. Stratified analysis ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39051160/
results from the Gruppo Italiano Studio Early Arthritis ...Conclusions: IXE effectiveness was highlighted after 6 months at both joint and skin levels and lasted up to 24 months in different clinical ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39843709/
Long-Term Safety of Ixekizumab Treatment in Patients with ...Conclusion: This integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult ...
Long-term safety of Ixekizumab in adults with psoriasis ...We report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO), ...
Safety of ixekizumab in patients with psoriatic arthritis: data ...This study includes a large safety analysis (N=1401; cumulative exposure=2247.7 patient-years) across four clinical trials with up to 3 years of ixekizumab ...
Adult Psoriasis (PsO) - Taltz - Eli LillyExplore the efficacy & safety data of Taltz® (ixekizumab) for adults with moderate to severe plaque psoriasis, including clearance data for scalp, nail, ...
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