A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 6 to <12 years) with moderate to-severe atopic dermatitis.
- Conditions
- Atopic dermatitis10014982
- Registration Number
- NL-OMON53683
- Lead Sponsor
- eo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
• Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
• Age 6 to <12 years.
• Body weight at baseline:
o >=17 kg for children aged 6 to <12 years at screening.
• History of AD for:
o >= 12 months for children aged 6 to <12 years at screening.
• 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.
• AD involvement of >=10% body surface area at screening and baseline.
• An EASI score of >=16 at screening and at baseline.
• An IGA score of >=3 at screening and at baseline.
• Emollient twice daily (or more) for at least 14 days prior to baseline.
• Active dermatologic conditions that may confound the diagnosis of AD or would
interfere with assessment of treatment.
• Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
• Treatment with the following immunomodulatory medications or bleach baths
within 4 weeks prior to baseline:
o Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate,
cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).
o Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or
intranasal delivery).
o 3 or more bleach baths during any week within the 4 weeks.
• Receipt of any marketed biological therapy or investigational biologic agents
(including immunoglobulin, anti-IgE, or dupilumab):
o 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.
o Other biologics (including dupilumab): within 3 months or 5 half-lives,
whichever is longer, prior to baseline.
• Active chronic or acute infection requiring treatment with systemic
antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before
the baseline visit.
• History of malignancy at any time before the baseline visit.
• History of anaphylaxis following any biological therapy.
• History of immune complex disease.
• Active or suspected endoparasitic infections.
• History of past or current tuberculosis or other mycobacterial infection.
• Established diagnosis of a primary immunodeficiency disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Ctrough at Week 16.<br /><br>• Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).<br /><br>• AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).<br /><br>• Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Number of treatment*emergent adverse events in the initial treatment period<br /><br>(Week 0-Week 16).<br /><br>• Anti-drug antibodies (status) in the initial treatment period (Week 0-Week<br /><br>16).<br /><br>• Number of treatment*emergent adverse events in the open-label treatment<br /><br>period (Week 16-Week 68).<br /><br>• Anti-drug antibodies (status) in the open-label treatment period (Week<br /><br>16-Week 68).<br /><br><br /><br>• Change in SCORAD from Week 0 - Week 68.<br /><br>• Change in POEM from Week 0 - Week 68.<br /><br>• Change in EASI from Week 0 to Week 68.</p><br>