Atopic Dermatitis study: Tralokinumab + TCS
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?
This is an investigational injectable medicine being studied as a potential treatment for moderate-to-severe atopic dermatitis in children and infants. It is designed to block a specific protein in the immune system that causes inflammation and itching.
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
- This study is testing whether a new injection works well and is safe. It also checks how it affects daily life and skin health.
- Who it's for
- You may be able to join if your child has severe eczema. They must be between 6 months and 12 years old.
- What's involved
- You would give your child a shot under the skin. They would also use a steroid cream on their skin.
- Time commitment
- The study lasts up to 4 years with visits every 2 to 6 weeks.
- 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.
- 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.
- 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 is enrolling
- 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
- Burlington, Canada
- Calgary, Canada
- Edmonton, Canada
- Hamilton, Canada
- Niagara Falls, Canada
- Saskatoon, Canada
+ 2 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, but 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?
This study is enrolling now at 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 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.