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Monoclonal Antibodies

Ixekizumab + Tirzepatide for Psoriasis (TOGETHER-PsO Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have ≥10% body surface area (BSA) involvement
Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months
Must not have
Have Type 1 Diabetes Mellitus (T1DM)
Have a prior or planned surgical treatment for obesity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 36
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to show that when people with moderate to severe plaque psoriasis and obesity or overweight are given ixekizumab and tirzepatide together, their psoriasis improves and they

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones for such medications may include injection site reactions, gastrointestinal issues, allergic responses, potential liver impact, and changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Over 10% of my body is affected.
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I have been diagnosed with moderate-to-severe plaque psoriasis for at least 6 months.
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My psoriasis is severe, with a sPGA score of 3 or more and a PASI score of 12 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 Diabetes.
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I have had or am planning to have surgery for weight loss.
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I have Type 2 Diabetes and take insulin.
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I have a history of medullary thyroid cancer or MEN syndrome type 2 in my family or myself.
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I have or had inflammatory bowel disease (Crohn's or ulcerative colitis).
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I have a history of pancreatitis.
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I have used ixekizumab or tirzepatide before.
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I had a bad reaction or no improvement with IL-17i or GLP-1 drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
Secondary study objectives
Percentage of Participants Achieving At Least 10% Weight Reduction
Percentage of Participants Achieving PASI 100
Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ixekizumab and TirzepatideExperimental Treatment2 Interventions
Ixekizumab concomitantly administered with tirzepatide SC.
Group II: IxekizumabExperimental Treatment1 Intervention
Ixekizumab administered subcutaneous (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520
Ixekizumab
2020
Completed Phase 4
~6560

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,658 Previous Clinical Trials
3,224,920 Total Patients Enrolled
65 Trials studying Obesity
53,615 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,380 Previous Clinical Trials
423,494 Total Patients Enrolled
47 Trials studying Obesity
33,157 Patients Enrolled for Obesity
~167 spots leftby Dec 2025
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