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
Public ClinicalTrials.gov record NCT05958407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating 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 for each participant. There will be up to 15 visits for each participant, 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 will not receive tralokinumab but are monitored for safety.
Study identification
- NCT ID
- NCT05958407
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 235 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2023 (Actual)
- Primary completion
- May 5, 2025 (Actual)
- Completion
- Sep 22, 2025 (Actual)
- Last update posted
- Aug 5, 2026
2023 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LEO Pharma Investigational Site | Birmingham | Alabama | 35209 | — |
| LEO Pharma Investigational Site | Fort Smith | Arkansas | 72916 | — |
| LEO Pharma Investigational Site | Fountain Valley | California | 92708 | — |
| LEO Pharma Investigational Site | Los Angeles | California | 90025 | — |
| LEO Pharma Investigational Site | Sacramento | California | 95816 | — |
| LEO Pharma Investigational Site | Farmington | Connecticut | 06032 | — |
| LEO Pharma Investigational Site | Hialeah | Florida | 33012 | — |
| LEO Pharma Investigational Site | Plainfield | Indiana | 46168 | — |
| LEO Pharma Investigational Site | Louisville | Kentucky | 40217 | — |
| LEO Pharma Investigational Site | New Orleans | Louisiana | 70115 | — |
| LEO Pharma Investigational Site | Bangor | Maine | 04401 | — |
| LEO Pharma Investigational Site | Caledonia | Michigan | 49316 | — |
| LEO Pharma Investigational Site | Detroit | Michigan | 48202 | — |
| LEO Pharma Investigational Site | Portsmouth | New Hampshire | 03801 | — |
| LEO Pharma Investigational Site | Cortland | New York | 13045 | — |
| LEO Pharma Investigational Site | New York | New York | 10075 | — |
| LEO Pharma Investigational Site | Portland | Oregon | 97201 | — |
| LEO Pharma Investigational Site | Portland | Oregon | 97210 | — |
| LEO Pharma Investigational Site | Nashville | Tennessee | 37211 | — |
| LEO Pharma Investigational Site | Dallas | Texas | 75225 | — |
| LEO Pharma Investigational Site | Frisco | Texas | 75034 | — |
| LEO Pharma Investigational Site | San Antonio | Texas | 78213 | — |
| LEO Pharma Investigational Site | Webster | Texas | 77598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05958407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05958407 live on ClinicalTrials.gov.