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NCT06311682RECRUITINGIRB Ready

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

(TRAPEDS 2)

Sponsored by LEO Pharma

Quick Self-Assessment

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Preparing your pre-screening questions...
๐Ÿ“Š
1 of 195 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Age 6 months to \<12 years at screening.
Body weight โ‰ฅ9 kg at screening.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
History of AD for: โ‰ฅ12 months for subjects aged โ‰ฅ6 years at screening and โ‰ฅ3 months for subjects aged 6 months to \<6 years at screening.
Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
AD involvement of โ‰ฅ10% body surface area at screening and baseline according to component A of SCORAD.
An EASI score of โ‰ฅ16 at screening and baseline.
An IGA score of โ‰ฅ3 at screening and baseline.
A Child Worst Itch NRS average score of โ‰ฅ4 (subjects aged โ‰ฅ6 years at screening) or a Scratch ObsRO average score of โ‰ฅ4 (subjects aged \<6 years at screening) during the week prior to baseline.

Exclusion Criteria

Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inh

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

195 participants

๐ŸŽ‚

Age Range

6 Months - 11 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

LEO Pharma

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

North Little Rock

Arkansas

Location available
View North Little Rock location page
RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
RECRUITING

Sacramento

California

Location available
View Sacramento location page
WITHDRAWN

San Diego

California

Location available
View San Diego location page
RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page

๐Ÿ“ And 6 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Atopic Dermatitis Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Atopic Dermatitis Treatment Options in Birmingham, Alabama

If you're searching for Atopic Dermatitis treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, North Little Rock, Palo Alto and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Atopic Dermatitis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 195 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Atopic Dermatitis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Atopic Dermatitis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Atopic Dermatitis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06311682. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.