A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline
研究概览
简要总结
Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families.
Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score in Phase 3 registrational trials, but objective data on upadacitinib's effect on elements of sleep disturbance such as Wake After Sleep Onset, or Sleep Efficiency, have not been collected.
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 Periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo. In Period 2, participants will be switched to receive open-label upadacitnib. Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide.
This study consists of a 35-day Screening Period; a 2-week randomized, double-blinded period (Period 1); a 22-week open-label extension period (Period 2); and a 30-day follow-up visit/call. Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD, according to Hanifin and Rajka criteria, with onset of symptoms at least 3 years prior to Baseline.
- •Eczema Area and Severity Index (EASI) score >= 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score >= 3, and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
- •Baseline weekly average of daily Worst Pruritus Numeric Rating Scale (NRS) >=
- •Moderate to severe sleep disturbance as confirmed by Baseline Patient Global Impression (PGI) Sleep AD (7-day) score of 3 or
- •Documented history of inadequate response to at least 1 prior systemic treatment for AD OR for whom systemic treatments, other than upadacitinib, are medically inadvisable (e.g., because of important side effects or safety risks).
排除标准
- •Prior exposure to dupilumab, tralokinumab, lebrikizumab, or nemolizumab.
- •Conditions or circumstances that could interfere with sleep assessments, including but not limited to:
- •History of sleep apnea, hypersomnia, or insomnia related to chronic pain;
- •Participant uses a continuous positive airway pressure (CPAP) machine;
- •History of chronic obstructive pulmonary disease or uncontrolled asthma;
- •Evidence of restless leg syndrome;
- •Participant is an evening or night shift worker;
- •Participant has sleep disturbance due to menopause, nocturia, or situational circumstances (e.g., caring for infant).
- •Participants who had prior exposure to any oral JAK inhibitor
研究组 & 干预措施
Upadacitinib
Participants randomized to receive upadacitinib Dose A once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks.
干预措施: Upadacitinib (Drug)
Placebo
Participants randomized to receive Placebo once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks.
干预措施: Placebo for Upadacitinib (Drug)
结局指标
主要结局
Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline
时间窗: Baseline to Week 2
The Worst Pruritus Numeric Rating Scale is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
次要结局
- Change from Baseline in Sleep Efficiency(Baseline to Week 2)
- Change from Baseline in Total Scratch Time(Baseline to Week 2)
- Change from Baseline in Nocturnal Scratching Bouts (≥ 5 seconds)(Baseline to Week 2)
- Change from Baseline in Wake After Sleep Onset (WASO) based on a sleep sensor.(Baseline to Week 2)