2024-512791-36-00招募中2 期
LP0162-1335: 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 (TRAlokinumab PEDiatric trial no. 1).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- 1. Ctrough at Week 16.
研究概览
简要总结
To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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 of ≥17 kg.
- •History of AD for ≥ 12 months 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.
- •History of past or current tuberculosis or other mycobacterial infection.
- •Established diagnosis of a primary immunodeficiency disorder.
- •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: 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.
- •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.
- •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 (including helminthic infections).
结局指标
主要结局
1. Ctrough at Week 16.
1. Ctrough at Week 16.
2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
次要结局
- 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16).
- 1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16).
- 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68).
- 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68).
- 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject)).
- 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject)).
- 7. Change in SCORAD from Week 0 to Week 68.
- 8. Change in POEM from Week 0 to Week 68.
- 9. Change in EASI from Week 0 to Week 68.
研究者
LEO Pharma Clinical Trials mailbox
Scientific
Leo Pharma A/S
研究点 (8)
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