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NCT06311682 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Atopic Dermatitis, sponsored by LEO Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT06311682 is a Phase 3 study of Atopic Dermatitis that is actively recruiting participants, run by LEO Pharma. The registered enrollment target is 195 participants, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06311682, a Phase 3 study of Atopic Dermatitis, is actively recruiting participants, sponsored by LEO Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.
Conditions Studied
Interventions
- DRUG Tralokinumab + TCS
- DRUG Placebo + TCS
Study Locations (20)
Other
- Leo Pharma Investigational site - Brussels
- Leo Pharma Investigational site - Ghent
- Leo Pharma Investigational site - Leuven
- Leo Pharma Investigational site - Liège
- Leo Pharma Investigational site - Burlington
California
- Leo Pharma Investigational site - Palo Alto
- Leo Pharma Investigational site - Sacramento
- Leo Pharma Investigational site - San Diego
- Leo Pharma Investigational site - San Diego
Florida
- Leo Pharma Investigational site - Jacksonville
- Leo Pharma Investigational site - Miami
- Leo Pharma Investigational site - Tampa
Alabama
- Leo Pharma Investigational site - Birmingham
Arkansas
- Leo Pharma Investigational site - North Little Rock
Georgia
- Leo Pharma Investigational site - Macon
Michigan
- Leo Pharma Investigational site - Waterford
Oklahoma
- Leo Pharma Investigational site - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2028-04-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06311682
The ClinicalTrials.gov registry entry for NCT06311682 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (68% lower). The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Tralokinumab + TCS is the first listed.
NCT06311682 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06311682 about?
NCT06311682 is a clinical study titled "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". The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of...
What is the current status of trial NCT06311682?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2024-06-10. Estimated completion is 2028-04-28.
What conditions does trial NCT06311682 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT06311682?
The interventions under investigation include: Tralokinumab + TCS (DRUG), Placebo + TCS (DRUG).
Who is sponsoring clinical trial NCT06311682?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06311682 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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