Status:

RECRUITING

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

Lead Sponsor:

LEO Pharma

Conditions:

Atopic Dermatitis

Eligibility:

All Genders

6-11 years

Phase:

PHASE3

Brief 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 ...

Eligibility Criteria

Inclusion Criteria:

  • Age 6 months to <12 years at screening.
  • Body weight ≥9 kg at screening.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 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 ≥10% body surface area at screening and baseline according to component A of SCORAD.
  • An EASI score of ≥16 at screening and baseline.
  • An IGA score of ≥3 at screening and baseline.
  • A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (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 inhibitors (JAK) within 1 week prior to baseline.
  • Treatment with bleach baths within 1 week prior to baseline.
  • Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.
  • Use of tanning beds or phototherapy within 4 weeks prior to baseline.
  • Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.
  • Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.
  • Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.
  • History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

Key Trial Info

Start Date :

June 10 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 28 2028

Estimated Enrollment :

195 Patients enrolled

Trial Details

Trial ID

NCT06311682

Start Date

June 10 2024

End Date

April 28 2028

Last Update

March 20 2026

Active Locations (72)

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Page 1 of 18 (72 locations)

1

Leo Pharma Investigational site

Birmingham, Alabama, United States, 35209

2

Leo Pharma Investigational site

North Little Rock, Arkansas, United States, 72117

3

Leo Pharma Investigational site

Palo Alto, California, United States, 94304

4

Leo Pharma Investigational site

Sacramento, California, United States, 95816

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 | DecenTrialz