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Monoclonal Antibodies
Ixekizumab + Tirzepatide for Psoriatic Arthritis (TOGETHER-PsA 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 signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria
Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints
Must not have
Have any prior use of ixekizumab or tirzepatide
Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 36
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to show that giving participants with psoriatic arthritis and obesity both ixekizumab and tirzepatide at the same time can help improve their arthritis symptoms and also help
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include allergic reactions, injection site reactions, gastrointestinal issues, and potentially others as seen with immune-modulating therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Psoriatic Arthritis for at least 6 months.
Select...
I have active Psoriatic Arthritis with at least 3 tender and 3 swollen joints.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have used ixekizumab or tirzepatide before.
Select...
I had a bad reaction or no improvement with IL-17i or GLP-1 drugs.
Select...
I have had or am planning to have surgery for weight loss.
Select...
I have a history of pancreatitis.
Select...
I have Type 1 Diabetes.
Select...
I have or had inflammatory bowel disease (Crohn's or ulcerative colitis).
Select...
I take insulin for my Type 2 Diabetes.
Select...
I or my family have a history of MTC or MEN type 2.
Select...
I have been diagnosed with an inflammatory arthritis condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 36
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 American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
Secondary study objectives
Percentage of Participants Achieving ACR50
Percentage of Participants Achieving at Least a 10% Weight Reduction
Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,680 Previous Clinical Trials
3,466,134 Total Patients Enrolled
6 Trials studying Psoriatic Arthritis
6,073 Patients Enrolled for Psoriatic Arthritis
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,591 Total Patients Enrolled
4 Trials studying Psoriatic Arthritis
1,573 Patients Enrolled for Psoriatic Arthritis