A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 156
- 试验地点
- 53
- 主要终点
- Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16
研究概览
简要总结
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.
Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
排除标准
- •Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
- •Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
研究组 & 干预措施
Placebo
Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.
干预措施: Placebo (Drug)
75 mg Cedirogant
Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.
干预措施: Cedirogant (Drug)
150 mg Cedirogant
Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.
干预措施: Cedirogant (Drug)
375 mg Cedirogant
Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
干预措施: Cedirogant (Drug)
结局指标
主要结局
Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16
时间窗: Baseline, Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
次要结局
- Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16(At Week 16)
- Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline(Baseline, Week 16)
- Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline(Baseline, Week 16)