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Tests treatment safety and results for Atopic Dermatitis
Official title 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
ClinicalTrials.gov ID: NCT06311682
What this study is testing
What is Tralokinumab + TCS?
Tralokinumab + TCS is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- 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 people aged ≥6 years at screening and ≥3 months for people aged 6 months to \<6 years at screening.
- Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
You likely can't join if
- Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical...
- Treatment with bleach baths within 1 week prior to baseline.
- Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine...
- 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...
See the full eligibility 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 people aged ≥6 years at screening and ≥3 months for people 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 (people aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (people aged \<6 years at screening) during the week prior to baseline.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- North Little Rock, Arkansas, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Macon, Georgia, United States
- Waterford, Michigan, United States
- Tulsa, Oklahoma, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Norfolk, Virginia, United States
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Burlington, Canada
- Calgary, Canada
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; North Little Rock, Arkansas, United States; Palo Alto, California, United States; Sacramento, California, United States; San Diego, California, United States; Jacksonville, Florida, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.