CTIS2022-500292-31-00招募中1 期
An adaptive, Phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson’s disease - ACI-7104-PD-2103
AC Immune S.A.0 个研究点目标入组 150 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of clinically established early idiopathic PD using the modified Movement. Disorder Society criteria, after excluding any other known or suspected cause of PD. The presence of motor symptoms should not be of more than 2 years at screening., Monotherapy treatment with L-Dopa at 300 mg per day, with a stable dose prior to baseline for 3 months. The subject has a reasonably low likelihood of requiring dose adjustment within the next 6 to 12 months after enrolment. Any exception to this rule has to be previously agreed with the Sponsor medical monitor., Male or female., Aged =40 to =75 years., Body weight range of =45 kg to =110 kg (99 to 242 lbs) and a body mass index of =18 to =34 kg/m2, Modified Hoehn-Yahr Stage I to II., A centrally read screening brain DaT-SPECT consistent with PD., Subjects can understand the informed consent form, are able and willing to provide written informed consent, and can be expected to comply with the study protocol according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and local regulations., Female subjects must be postmenopausal for at least 1 year and/or surgically sterilized, or, if they are woman of childbearing potential or not postmenopausal, they must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of safety follow-up period (approximately 108 weeks). Male subjects in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by female partners during the whole study duration. Men must refrain from donating sperm during this same period. The female partners of male subjects should use a highly effective method of contraception with a failure rate of less than 1% per year from screening until the end of the safety follow-up period (approximately 108 weeks). The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
排除标准
- •Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including but not limited to, progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia., Clinically significant concomitant disease or condition within 6 months prior to screening, or as specified below, that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the study subject (for details refer to protocol), Current, or history of, alcohol or drug (including cannabis) abuse or other dependence (except nicotine dependence) within 12 months before screening., Subjects with known hypersensitivity to the study vaccine or placebo components., Subjects who previously received a vaccination (ie, influenza vaccine and COVID-19) within the last 4 weeks prior to randomization, or standard-of-care immunizations (eg, tetanus, herpes zoster, pneumococcal pneumonia) within the last 2 weeks prior to randomization., Subjects being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower., Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2)., History of PD-related freezing episodes or falls., History of brain surgery or any neurosurgical procedures., Reside in a nursing home or assisted care facility., A history of cancer within 5 years of baseline with the exception of fully excised non-melanoma skin cancers or nonmetastatic prostate cancer that has been stable for at least 6 months, or cervical intraepithelial neoplasia stage I uterine cancer., History of and/or screening brain MRI scan indicative of, clinically significant abnormality including but not limited to prior hemorrhage or infarct >1 cm3 or >3 lacunar infarcts., Diagnosis of a significant central nervous system disease other than PD (including but not limited to Huntington’s disease, normal pressure hydrocephalus, cerebrovascular disease including stroke, fronto-temporal dementia, Alzheimer’s disease, dementia with Lewy bodies, multiple sclerosis, brain tumor); history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child., Presence of psychiatric symptoms (eg, confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening and baseline). Note: mild depression, depressive mood, or mild anxiety arising in the context of PD are not exclusionary.
研究者
相似试验
进行中（未招募）
1 期
A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared with Placebo in Participants with Knee Osteoarthritis PaiKnee osteoarthritis painMedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395CTIS2022-500228-31-00Paradigm Biopharmaceuticals (USA) Inc.898
进行中（未招募）
1 期
A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared with Placebo in Participants with Knee Osteoarthritis PaiCTIS2022-500228-31-01Paradigm Biopharmaceuticals (USA) Inc.938
进行中（未招募）
1 期
A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancerRecurrent/Metastatic Head and Neck Squamous Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864EUCTR2019-002263-99-IEGlaxoSmithKline Research & Development Ltd315
进行中（未招募）
1 期
A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancerEUCTR2019-002263-99-ATGlaxoSmithKline Research & Development Ltd600
已完成
2 期
A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (study 209229)NL-OMON52820GlaxoSmithKline25