Ixekizumab + Tirzepatide for Psoriasis

(TOGETHER-PsO Trial)

Recruiting in Palo Alto (17 mi)

+73 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Insulin, IL-17 inhibitors

Disqualifiers: T1DM, Obesity surgery, Cancer, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis 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 psoriasis 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.

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.

What data supports the effectiveness of the drug Ixekizumab for treating psoriasis?

Research shows that Ixekizumab is effective for treating moderate to severe plaque psoriasis, with patients experiencing significant skin improvement and better quality of life. In clinical trials, many patients saw a 75% reduction in psoriasis severity after 12 weeks, and benefits were maintained for up to 60 weeks. ^{1 2 3 4 5}

Is the combination of Ixekizumab and Tirzepatide safe for humans?

Ixekizumab has been used safely in humans for conditions like psoriasis, with studies showing it is generally well tolerated over long periods. However, there is no specific safety data available for the combination of Ixekizumab and Tirzepatide. ^{2 4 6 7 8}

How is the drug Ixekizumab + Tirzepatide unique for treating psoriasis?

This drug combination is unique because it combines Ixekizumab, which targets and blocks a specific protein (IL-17A) involved in inflammation, with Tirzepatide, a medication known for its role in managing blood sugar and weight, potentially offering a novel approach to treating psoriasis by addressing both inflammation and metabolic factors. ^{1 2 4 9 10}

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

Eligibility Criteria

This trial is for adults with moderate-to-severe plaque psoriasis who are also overweight or obese. Participants should be interested in improving their skin condition and reducing weight. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

Over 10% of my body is affected.

Have a body mass index (BMI) of ≥27 kilograms per meter squared (kg/m²)

My psoriasis is severe, with a sPGA score of 3 or more and a PASI score of 12 or more.

Exclusion Criteria

I have Type 1 Diabetes.

I have had or am planning to have surgery for weight loss.

I have Type 2 Diabetes and take insulin.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Treatment

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

36 weeks

Up to 12 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 weeks

Treatment Details

Interventions

• Ixekizumab (Monoclonal Antibodies)
• Tirzepatide (Other)

Trial Overview The study tests if taking Ixekizumab together with Tirzepatide helps improve psoriasis and supports weight loss better than just Ixekizumab alone. The trial involves up to 12 visits over a maximum of 61 weeks, including treatment and follow-up periods.

Participant Groups

Group I: Ixekizumab and Tirzepatide Experimental Treatment 2 Interventions

Ixekizumab concomitantly administered with tirzepatide SC.

Group II: Ixekizumab Experimental Treatment 1 Intervention

Ixekizumab administered subcutaneous (SC).

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

Findings from Research

In a study involving 83 healthy adults, ixekizumab (IXE) was found to be noninferior to a control in terms of immune response to tetanus and pneumococcal vaccines, indicating it does not hinder the effectiveness of these vaccines.

IXE was well tolerated, with only mild treatment-emergent adverse events reported, suggesting it is a safe option for patients receiving vaccinations while on this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. Gomez, EV., Bishop, JL., Jackson, K., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab: First Global Approval. Markham, A.[2018]

In a study of 91 Japanese patients with moderate-to-severe psoriasis, ixekizumab demonstrated rapid improvements in skin clearance and quality of life, with significant enhancements in the Dermatology Life Quality Index (DLQI) and Itch Numeric Rating Scale (NRS) at weeks 4 and 12.

Patients who achieved complete skin clearance (PASI 100) by week 4 or 12 experienced better outcomes in itch relief, indicating that faster responses to treatment are crucial for improving overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J). Honma, M., Cai, Z., Burge, R., et al.[2020]

In phase 3 UNCOVER trials, ixekizumab was found to be significantly more effective than placebo and etanercept in treating moderate to severe plaque psoriasis, with patients showing a ≥75% reduction in psoriasis severity within 12 weeks.

Ixekizumab was generally well tolerated, with low immunogenicity and sustained clinical responses over 60 weeks, making it a promising treatment option that requires only one maintenance dose every 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab: A Review in Moderate to Severe Plaque Psoriasis. Syed, YY.[2017]

In a study of 136 psoriasis patients treated with ixekizumab over 6 months, significant improvements were observed in disease severity, with a mean decrease in the Investigator Global Assessment (IGA*BSA) score of -45.5 and a body surface area (BSA) reduction of -12.4.

A high percentage of patients achieved significant treatment milestones, including 84.6% reaching an absolute Psoriasis Area and Severity Index (PASI) score of ≤ 5, indicating effective management of psoriasis symptoms across various patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease response and patient-reported outcomes among initiators of ixekizumab. Shahriari, M., Harrison, RW., Burge, R., et al.[2022]

A case study of a 51-year-old woman treated with ixekizumab for plaque psoriasis revealed a rare instance of varicella zoster virus (VZV) reactivation, leading to meningoradiculitis and cerebral venous thrombosis, suggesting a potential risk of viral reactivation during treatment with this IL-17 inhibitor.

Despite the reported safety profile of ixekizumab, this case highlights the need for vigilance regarding neurological complications from VZV, even in the absence of skin lesions, and emphasizes the importance of PCR testing of cerebrospinal fluid for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meningoradiculitis due to varicella zoster virus reactivation in a patient treated with ixekizumab. Dubois, M., Morel, G., Tone, A., et al.[2021]

In a study of 198 patients with moderate-to-severe plaque psoriasis treated with ixekizumab for 24 months, 94.3% achieved a 75% improvement in psoriasis severity (PASI75), demonstrating its long-term effectiveness.

Patients began to see improvements as early as 4 weeks after starting treatment, with significant enhancements in quality of life noted by Week 12, indicating that ixekizumab not only reduces symptoms but also positively impacts overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab is effective in the long-term management in moderate-to-severe plaque psoriasis: results from an Italian retrospective cohort study (the LOTIXE study). Chiricozzi, A., Megna, M., Giunta, A., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ixekizumab: First Global Approval. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J). [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Ixekizumab: A Review in Moderate to Severe Plaque Psoriasis. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Disease response and patient-reported outcomes among initiators of ixekizumab. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ixekizumab for the treatment of moderate-to-severe plaque psoriasis: the first septennium. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: Data from 17 Clinical Trials with Over 18,000 Patient-Years of Exposure. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Meningoradiculitis due to varicella zoster virus reactivation in a patient treated with ixekizumab. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). [2019]

10. England pubmed.ncbi.nlm.nih.gov

Ixekizumab is effective in the long-term management in moderate-to-severe plaque psoriasis: results from an Italian retrospective cohort study (the LOTIXE study). [2023]