EUCTR2021-005573-12-NL进行中（未招募）1 期
A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 2 to <12 years) with moderate-to-severe atopic dermatitis. - TRAPEDS 1
EO Pharma A/S0 个研究点目标入组 53 人开始时间: 2022年5月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- •- Age 2 to <12 years.
- •- Body weight at baseline:
- •- =9 kg for children aged 2 to <6 years at screening.
- •- =17 kg for children aged 6 to <12 years at screening.
- •- History of AD for:
- •- = 3 months for children aged 2 to <6 years at screening.
- •- = 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 53
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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:
- •- Systemic immunosuppressive/immunomodulating drugs (e.g.
- •methotrexate, cyclosporine, azathioprine, mycophenolate mofetil,
- •JAK inhibitors).
- •- Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or
- •intranasal delivery).
- •- 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):
- •- 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.
- •- Other biologics (including dupilumab): within 3 months or 5 halflives,
- •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.
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