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NCT05194540 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT05194540: Completed Phase 3 study, sponsored by LEO Pharma.
NCT05194540 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05194540, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
Primary Outcome
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Interventions
- DRUG Tralokinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 3 |
What the finished NCT05194540 record still lists
NCT05194540 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Tralokinumab is the first listed.
NCT05194540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05194540 about?
NCT05194540 is a clinical study titled "Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)". The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
What is the current status of trial NCT05194540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2022-01-13. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05194540?
The interventions under investigation include: Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT05194540?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05194540's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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