EUCTR2012-002763-10-ES进行中（未招募）不适用
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Fully understand all elements of and have signed and dated the written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
- •2.Male or female subjects, ?18 to ?75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening;
- •3.Plaque psoriasis covering between 10% to 30 % of body surface area (BSA);
- •4.PASI severity moderate to severe, scoring at least 10 but no higher than 20;
- •5.For a female subject; either:
- •- subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy
- •- agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
- •Males must use at least one method of contraception (e.g., condom) throughout the study;
- •6.In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
- •2.Received any investigational drug within 30 days of screening;
- •3.Previous participation in a VB-201 study;
- •4. Previously received or is currently receiving systemic biologic treatment for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc).
- •5.The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline:
- •?Topical psoriasis treatments: 2 weeks;
- •?Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer);
- •?Phototherapy: 4 weeks
- •6.The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
- •7.The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator?s Brochure);
- •8.Any other acute or chronic medical condition that, in the opinion of the investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study;
- •9.Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal:
- •?Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase ?2.0 times the upper limit of normal (ULN) or
- •?Cytopenia (to include any of the following: WBC <3.5?103/?L; Hgb <10 g/dL; platelets <120?103/?L; neutrophils absolute <1.5?103/?L; lymphocytes absolute <0.8?103/?L) or
- •?Creatinine ?1.25 times the upper limit of normal (ULN);
- •Note: If, in the investigator?s opinion, there is no reason for the test result(s) to be abnormal, the abnormal test(s) may be repeated once during the screening period.
- •10.History of cancer, the exception is skin cancer, see below.
- •?Subjects with >3 previous squamous cell skin cancer lesions are excluded;
- •?Subjects who had histologically controlled excision of basal cell and/or squamous cell carcinoma of the skin and have been declared to have no evidence of tumor can be enrolled;
- •?Subjects who had basal cell and/or squamous cell carcinoma of the skin removed and have not met these criteria can be enrolled if the skin cancer was removed >3 years prior to study participation and there is no evidence of recurrence;
- •11.Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of baseline, or a history or presence of recurrent or chronic infection [e.g. viral infections, (including hepatitis B or C, HIV), bacterial infections, systemic fungal infections, or syphilis];
- •12.Evidence of tuberculosis as indicated by a positive Quantiferon test at screening or within 30 days prior to screening;
- •13.Chest X-ray within 3 months of screening visit suggestive of tuberculosis or active fungal infection;
- •14. History of substance abuse, including alcohol abuse, within the past year;
- •15.Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; Subjects with depression that has been adequately controlled for at least 6 months may enroll in the study];
研究者
相似试验
进行中（未招募）
不适用
A clinical study to Evaluate the Efficacy and Safety of the oral study medication VB-201 in Patients with Moderate to Severe Plaque PsoriasisPatients with Moderate to Severe Plaque PsoriasisMedDRA version: 17.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858EUCTR2012-002763-10-DEVascular Biogenics Ltd.180
进行中（未招募）
1 期
A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)Primary sclerosing cholangitis (PSC)MedDRA version: 20.1Level: LLTClassification code 10036732Term: Primary sclerosing cholangitisSystem Organ Class: 100000004871EUCTR2020-001428-33-BEPliant Therapeutics, Inc121
招募中
2 期
A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC)Primary Sclerosing Cholangitis (PSC) and suspected liver fibrosis10019654NL-OMON56399Pliant Therapeutics Inc.,5
进行中（未招募）
1 期
A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisidiopathic pulmonary fibrosisMedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-002709-23-ITPliant Therapeutics Inc.84
进行中（未招募）
1 期
A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisIdiopathic pulmonary fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-002709-23-GBPliant Therapeutics Inc.40