A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieve a PPPASI-50 at Week 16
研究概览
简要总结
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.
The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
- •Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
- •Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
- •Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Subject has a diagnosis of plaque-type psoriasis.
- •Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
- •Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
- •Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
- •Subject has periodontitis obviously requiring treatment at screening.
- •Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.
- •Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.
- •Subject is pregnant or breastfeeding.
研究组 & 干预措施
Placebo then Apremilast 30mg BID
Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
干预措施: Apremilast (Drug)
Placebo then Apremilast 30mg BID
Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
干预措施: Placebo (Drug)
Apremilast 30 mg BID then Apremilast 30 mg BID
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
干预措施: Apremilast (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve a PPPASI-50 at Week 16
时间窗: At Week 16
PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
次要结局
- Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase(Baseline to Week 16)
- Change From Baseline in PPSI Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase(Weeks 2 to 14)
- Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase(Weeks 2 to 16)
- Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16(Baseline to Week 16)
- Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .(Baseline to Week 16)
- Change From Baseline in PPPASI Total Score at Week 16(Baseline and Week 16)
- AUC for PPSI Total Score From Baseline Through Week 16(Baseline to Week 16)
- Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase(Weeks 2 to 16)
- Change From Baseline in Participant VAS Assessment for PPP Symptoms(Baseline and Weeks 2,4,6,8,12,16)
- Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase.(Weeks 2 to 16)