NCT07190391尚未招募不适用
A Multi-center, Single-arm, Open-label, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Apremilast in Patients With Moderate-to-severe Psoriasis
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 425 人开始时间: 2025年9月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 425
- 主要终点
- Proportion of patients who achieved PASI 75
研究概览
简要总结
This study aims to evaluate the efficacy and safety of Apremilast tablets in patients with psoriasis over 32 weeks, through a multicenter, single-arm, open-label, phase 4 clinical trial.
详细描述
In this clinical trial, patients with psoriasis will be informed about study participation and written informed consent will be obtained voluntarily. Eligible participants, based on inclusion and exclusion criteria, will be assigned a registration number. Participants will receive Apremilast for 32 weeks and visit the study site at three time points: Visit 1 (screening and baseline, Week 0), Visit 2 (Week 16 ± 4), and Visit 3 (Week 32 ± 4). At each visit, demographic information, efficacy assessments, and adverse event evaluations will be conducted according to the study schedule.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥19 years at the time of enrollment.
- •Patients with moderate to severe psoriasis persisting for ≥6 months.
- •Patients with a PASI (Psoriasis Area and Severity Index) score between 5 and 10, requiring pharmacological treatment.
- •Patients who have been fully informed about the study, have understood the explanation, and have voluntarily signed the informed consent form.
- •Patients who are considered cooperative and able to participate until the end of the study.
排除标准
- •Patients with a history of hypersensitivity to apremilast.
- •Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Pregnant or breastfeeding women.
- •Patients (or their spouse/partner) who do not agree to use medically acceptable and appropriate methods of contraception* during the study period.
- •* Medically acceptable and appropriate methods of contraception include: hormonal contraception (implants, injectables, oral contraceptives, etc.), intrauterine devices (copper IUD, hormone-releasing intrauterine system), salpingectomy, tubal ligation, hysterectomy, vasectomy, dual barrier methods (male condom and female condom, cervical cap, diaphragm, contraceptive sponge used in combination), or single barrier method combined with spermicide.
- •Patients receiving strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort).
- •Patients with severe renal impairment requiring hemodialysis or peritoneal dialysis.
- •Patients who have previously received Apremilast (ApsoLla®) prior to enrollment, or those currently participating in another clinical trial involving an investigational medicinal product or medical device.
- •(However, patients enrolled in non-interventional studies or who have completed participation in another clinical trial are eligible.)
- •Patients with a history of psychiatric disorders (e.g., substance abuse, depression).
- •Patients who, in the opinion of the investigator, are otherwise considered unsuitable for participation in this study.
结局指标
主要结局
Proportion of patients who achieved PASI 75
时间窗: 16 weeks
Proportion of patients who achieved PASI 75 at week 16
次要结局
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75(32 weeks)
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50(32 weeks)
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90(32 weeks)
- [Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2(32 weeks)
- [Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index)(32 weeks)
- [Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1(32 weeks)
- [Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index)(32 weeks)
- [Patient-Reported Endpoints]Change from baseline in Pruritus NRS (Numeric Rating Scale)(16 weeks)
- Change from baseline in Pruritus NRS (Numeric Rating Scale)(32 weeks)
- [Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment)(32 weeks)
- [Patient-Reported Endpoints]Shift in distribution of PaGA scores(32 weeks)
- [Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1(32 weeks)
研究者
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