NL-OMON53683招募中2 期
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. - TRAPEDS 1
eo Pharma0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •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.
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:
- •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.
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