NCT01483924已完成2 期
A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ApoPharma
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Number of Patients With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.
详细描述
A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1
B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days
C) To evaluate the efficacy and pharmacodynamics of Apo805K1
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥
- •Male and female subjects 18 to 65 years of age, inclusive.
- •At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
- •Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.
排除标准
- •Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
- •Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
- •Phototherapy within 30 days prior to Baseline assessment and during the study.
- •Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
- •History of liver disease or abnormal liver enzymes
- •Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
- •Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
- •Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
- •History of chronic infection or malignancy
研究组 & 干预措施
30 mg Apo805K1, or placebo
Experimental
干预措施: Apo805K1 (Drug)
10 mg Apo805K1, or placebo
Experimental
干预措施: Apo805K1 (Drug)
60 mg Apo805K1, or placebo
Experimental
干预措施: Apo805K1 (Drug)
100 mg Apo805K1, or placebo
Experimental
干预措施: Apo805K1 (Drug)
结局指标
主要结局
Number of Patients With Adverse Events
时间窗: 12 Weeks
The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
次要结局
- Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
- Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
- AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
- T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
- Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores(Baseline to 12 Weeks)
- Efficacy of APO805K1 as Assessed by Achievement of PASI-75(12 weeks)
- Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score(Baseline to 12 weeks)
- Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores(Baseline to 12 weeks)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
1 期
A 12-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic GastroparesisMedDRA version: 20.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersDiabetic GastroparesisEUCTR2017-002177-20-LVAllergan Ltd.2,500
进行中（未招募）
1 期
A 12-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic GastroparesisMedDRA version: 20.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersDiabetic GastroparesisEUCTR2017-002177-20-ROAllergan Ltd.311
进行中（未招募）
1 期
A 12-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic GastroparesisDiabetic GastroparesisMedDRA version: 20.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-002136-16-ITALLERGAN LIMITED2,500
招募中
Unknown
A human study to evaluate the effect of CKDB001 on Cognitive-enhancing functioKCT0009298Chong Kun Dang Bio100
Unknown
2 期
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset SeizuresCTRI/2010/091/001332ovartis Health care Private Limited57