A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline
研究概览
简要总结
Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms.
Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil.
Participants will receive the following for up to 52 weeks:
Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52.
Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52.
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age.
- •Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- •Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits.
- •Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits.
- •>= 10% body surface area of AD involvement at the Screening and Baseline Visits.
- •Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits.
- •Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication.
排除标准
- •Prior exposure to any systemic Janus kinase (JAK) inhibitor.
- •Prior exposure to dupilumab.
- •Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
- •Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks.
- •Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer.
- •Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
- •Oral or parenteral traditional medicine within 4 weeks.
- •Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.
研究组 & 干预措施
Upadacitinib Dose A
Participants will receive Upadacitinib Dose A once daily (QD).
干预措施: Upadacitinib (Drug)
Upadacitinib Dose B
Participants will receive Upadacitinib Dose B QD.
干预措施: Upadacitinib (Drug)
Placebo for Upadacitinib Followed by Upadacitinib Dose A
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.
干预措施: Upadacitinib (Drug)
Placebo for Upadacitinib Followed by Upadacitinib Dose A
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.
干预措施: Placebo for Upadacitinib (Drug)
Placebo for Upadacitinib Followed by Upadacitinib Dose B
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.
干预措施: Upadacitinib (Drug)
Placebo for Upadacitinib Followed by Upadacitinib Dose B
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.
干预措施: Placebo for Upadacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline
时间窗: Baseline to Week 16
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Number of Participants With Adverse Events (AE)
时间窗: Up to Week 52
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline(Baseline to Week 16)