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A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)
Plain-language guide to NCT06864026: phase 4 interventional trial of Tirzepatide, psoriasis and psoriatic arthritis, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06864026
- Phase
- phase 4
- Status
- active, not recruiting
- Start
- 2025-03-06
- Completion (planned or actual)
- 2027-08
- Participants
- 200 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Psoriatic Arthritis; Overweight or Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Tirzepatide for psoriasis and psoriatic arthritis.
The study will last up to 12 months.
It had 1 arm (groups): Tirzepatide (experimental).
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
The registry classes the interventions as drug.
Who Took Part
The registry lists 200 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA. Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide. Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).
The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: have currently received ixekizumab for more than 4 months or less than 2 months; had any exposure to tirzepatide or other glucagon-like peptide-1 (glp-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide); are currently enrolled in any other clinical study.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2025-03-06 with completion listed for 2027-08.
It ran at 55 sites in United States (53) and Puerto Rico (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy (time frame: 12 Months).
It also tracked 13 secondary outcomes, for example Percentage of Participants Achieving Tender Joint Count (TJC) ≤1, Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1, Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2, Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15, Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2 and Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Tirzepatide in 200 people with psoriasis and psoriatic arthritis.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, Psoriasis and psoriatic arthritis research.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.