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COMPLETED Phase 3

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

NCT05958407 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.

Interventions

  • DRUG Placebo
  • DRUG Tralokinumab

Study Locations (20)

California

  • LEO Pharma Investigational Site — Fountain Valley
  • LEO Pharma Investigational Site — Los Angeles
  • LEO Pharma Investigational Site — Sacramento

Michigan

  • LEO Pharma Investigational Site — Caledonia
  • LEO Pharma Investigational Site — Detroit

New York

  • LEO Pharma Investigational Site — Cortland
  • LEO Pharma Investigational Site — New York

Oregon

  • LEO Pharma Investigational Site — Portland
  • LEO Pharma Investigational Site — Portland

Alabama

  • LEO Pharma Investigational Site — Birmingham

Arkansas

  • LEO Pharma Investigational Site — Fort Smith

Connecticut

  • LEO Pharma Investigational Site — Farmington

Florida

  • LEO Pharma Investigational Site — Hialeah

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2023-08-28
Est. Completion 2025-09-22
Phase Phase 3

Sponsor

LEO Pharma

39 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05958407

The ClinicalTrials.gov registry entry for NCT05958407 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05958407 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05958407 about?

NCT05958407 is a clinical study titled "A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy". The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quali...

What is the current status of trial NCT05958407?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2023-08-28. Estimated completion is 2025-09-22.

What conditions does trial NCT05958407 study?

This clinical trial studies the following conditions: Atopic Dermatitis, Atopic Hand Eczema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05958407?

The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05958407?

This trial is sponsored by LEO Pharma, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05958407 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial