EUCTR2014-003492-36-GB进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis - CIMPACT
CB Biopharma, SPR0 个研究点目标入组 561 人开始时间: 2014年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 561
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
入选标准
- •1.Provided informed consent
- •2.Adult men or women =18 years
- •3.Chronic plaque psoriasis for at least 6 months
- •4.Baseline psoriasis activity and severity index =12 and body surface area =10% and Physician’s Global Assessments score =3
- •5.Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- •6.Other protocol-defined inclusion criteria may apply
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Erythrodermic, guttate, generalized pustular form of psoriasis
- •2.History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
- •3.Congestive heart failure
- •4.History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- •5.History of other malignancy concurrent malignancy as described in the protocol
- •6.History of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
- •7.Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
- •8.Any other condition which, in the Investigator’s judgment, would make the subject unsuitable for participation in the study
- •9.Other protocol-defined exclusion criteria may apply
- •10.Prior etanercept use
- •11. Subjects with concurrent acute or chronic viral hepatitis B or C or with known human immunodeficiency virus (HIV) infection.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of bimekizumab compared to placebo and an active comparator in adult subjects with moderate to severe chronic plaque psoriasisModerate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-003425-42-ITCB Biopharma SR567
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 16.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-HUAmgen Inc450
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 17.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-BGAmgen Inc600
进行中（未招募）
不适用
GAMMA - Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreasmetastatic adenocarcinoma of the pancreasMedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-020398-18-ESAmgen Inc.825
进行中（未招募）
1 期
A Phase 3 Study in Moderate to Severe Chronic Psoriasis PatientsMedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858Plaque PsoriasisEUCTR2014-003492-36-BGCB Biopharma, SPR561