A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis
Public ClinicalTrials.gov record NCT06311682. 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 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)
Study identification
- NCT ID
- NCT06311682
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- LEO Pharma
- Industry
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Interventions
- Tralokinumab + TCS Drug
- Placebo + TCS Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Months to 11 Years
- 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
- Jun 9, 2024
- Primary completion
- Oct 19, 2026
- Completion
- Apr 27, 2028
- Last update posted
- Jun 24, 2026
2024 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Leo Pharma Investigational site | Birmingham | Alabama | 35209 | Recruiting |
| Leo Pharma Investigational site | North Little Rock | Arkansas | 72117 | Recruiting |
| Leo Pharma Investigational site | Palo Alto | California | 94304 | Recruiting |
| Leo Pharma Investigational site | Sacramento | California | 95816 | Recruiting |
| Leo Pharma Investigational site | San Diego | California | 92108 | Withdrawn |
| Leo Pharma Investigational site | San Diego | California | 92123 | Recruiting |
| Leo Pharma Investigational site | Jacksonville | Florida | 32256 | Recruiting |
| Leo Pharma Investigational site | Miami | Florida | 33156 | Recruiting |
| Leo Pharma Investigational site | Tampa | Florida | 33613 | Recruiting |
| Leo Pharma Investigational site | Macon | Georgia | 31217 | Recruiting |
| Leo Pharma Investigational site | Waterford | Michigan | 48328 | Recruiting |
| Leo Pharma Investigational site | Tulsa | Oklahoma | 74136 | Recruiting |
| Leo Pharma Investigational site | Portland | Oregon | 97239 | Recruiting |
| Leo Pharma Investigational site | Charleston | South Carolina | 27420 | Recruiting |
| Leo Pharma Investigational site | Norfolk | Virginia | 23502 | Recruiting |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06311682, 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 Jun 24, 2026 · Synced Jun 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06311682 live on ClinicalTrials.gov.