Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 136 participants
Start Date 2022-01-13
Est. Completion 2023-06-21
Phase Phase 3
LEO Pharma

65 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01555892 · 136 participants · Phase 1

    Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE

  • NCT03216525 · 136 participants · Phase 3

    Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

  • NCT04476901 · 136 participants · Phase 2

    Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

  • NCT04603898 · 136 participants · NA

    Oxalate Formation From Ascorbic Acid

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05194540, the US trial registry maintained by the National Library of Medicine. NCT05194540 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.