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Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis.
EU CTIS ID: 2024-512791-36-00
What this study is testing
To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- 2. Age 6 to <12 years.
- 3. Body weight at baseline of ≥17 kg.
- 4. History of AD for ≥ 12 months at screening.
- 5. History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
- 6. AD involvement of ≥10% body surface area at screening and baseline.
You likely can't join if
- 1. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- 10. History of past or current tuberculosis or other mycobacterial infection.
- 11. Established diagnosis of a primary immunodeficiency disorder.
- 2. Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- 3. Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline: 3a. Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). 3b. Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). 3c. 3 or more bleach baths during any week within the 4 weeks.
- 4. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): 4a. Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. 4b. Other biologics (including dupilumab): within 3 months or 5 half-lives, whichever is longer, prior to baseline.
See the full eligibility criteria
- 1. Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- 2. Age 6 to <12 years.
- 3. Body weight at baseline of ≥17 kg.
- 4. History of AD for ≥ 12 months at screening.
- 5. History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
- 6. AD involvement of ≥10% body surface area at screening and baseline.
- 7. An EASI score of ≥16 at screening and at baseline.
- 8. An IGA score of ≥3 at screening and at baseline.
- 9. Emollient twice daily (or more) for at least 14 days prior to baseline.
- 1. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- 10. History of past or current tuberculosis or other mycobacterial infection.
- 11. Established diagnosis of a primary immunodeficiency disorder.
- 2. Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- 3. Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline: 3a. Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). 3b. Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). 3c. 3 or more bleach baths during any week within the 4 weeks.
- 4. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): 4a. Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. 4b. Other biologics (including dupilumab): within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- 5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
- 6. History of malignancy at any time before the baseline visit.
- 7. History of anaphylaxis following any biological therapy.
- 8. History of immune complex disease.
- 9. Active or suspected endoparasitic infections (including helminthic infections).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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 EU CTIS; the study team decides eligibility.