EUCTR2019-003797-10-DE进行中（未招募）1 期
A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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.Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as defined by the revised El Escorial criteria (Brooks et al. 2000)
- •2.At least 18 years of age
- •3.Slow vital capacity =60% of the predicted value at screening
- •4.Onset of ALS symptoms within 72 weeks prior to screening
- •5.Total ALSFRS-R score of =30 at screening
- •6.Women of childbearing potential defined as any woman who has experienced menarche and who is NOT permanently sterile or postmenopausal
- •a.must have a negative pregnancy test at screening and
- •b.must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of investigational product.
- •i.Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
- •7.Males must agree to
- •a.use protocol defined methods of contraception and
- •b.refrain from donating sperm for the duration of the study and 90 days after their last dose of investigational product.
- •8.Have vaccination against Streptococcus pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) either within 5 years prior to Baseline Visit 2b, or agree to receive vaccination at least 7 days prior to Baseline Visit 2b. Vaccination is mandatory, unless documented evidence exists that subjects are nonresponders to vaccination (as evidenced by titers or display titer levels within acceptable local limits).
- •9.Willing and able to give informed consent and comply with study procedure and assessments (including at-home assessments)
- •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) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1.Confirmed or suspected other causes of neuromuscular weakness
- •2.Diagnosis of another neurodegenerative disease(s)
- •3.Subject with significant cognitive impairment, clinical dementia, or psychiatric illness that in the opinion of the investigator may increase subject’s risk by participating in the study or confound the outcome of the study
- •4.Subjects with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension)
- •5.Current use or anticipated need, in the opinion of the investigator, of a diaphragm pacing system during the randomized treatment period
- •6.Riluzole initiation or change in dose within 30 days prior to the start of the screening period or planned initiation during study participation. If using riluzole, the subject should remain on the drug throughout Part 2 the duration of study participation, but the dosage may be altered or the drug discontinued at any time by the investigator for any safety concern. Riluzole-naïve subjects are allowed in the study.
- •7.Edaravone initiation or change in dose within 60 days prior to the start of the screening period or planned initiation during study participation. If using edaravone, the subject should remain on the drug throughout Part 2 of study participation, but the dosage may be altered or the drug discontinued at any time by the investigator for any safety concern. Edaravone-naïve subjects are allowed in the study.
- •8.Positive response to Item 4 or 5 of the Columbia Suicide Severity Rating Scale
- •9.Subjects with detectable hepatitis C by polymerase chain reaction at screening
- •10.Subjects with chronic inactive hepatitis B with viral loads >1000 IU/mL (>5000 copies/mL) at screening. Eligible subjects who are chronic active carriers (=1000 IU/mL) must receive prophylactic antiviral treatment according to local country guidelines (eg, entecavir, tenofovir, lamivudine)
- •11.History of an aggressive lymphoma or presence of a lymphoma requiring therapy by itself
- •12.Active or overt malignant disease other than basal cell carcinoma or cutaneous squamous cell carcinoma
- •13.Received organ transplant
- •14.Presence or suspicion of liver dysfunction as indicated by elevated alanine aminotransferase, aspartate aminotransferase, or bilirubin levels >2 × the upper limit of normal
- •15.Presence or suspicion of severe recurrent or chronic infections that, in the opinion of the investigator, increase the subject’s risk by participating in the study
- •16.Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation
- •17.Use of any other complement inhibitor within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation
- •18.If breastfeeding, unwilling to discontinue for the duration of the study and for at least 6 months after final dose of drug
- •19.Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subject’s risk by participating in the study or confound the outcome of the study
- •20. Subjects with known allergy or hypersensitivity to pegcetacoplan or to any of the comp
研究者
相似试验
进行中（未招募）
1 期
GB004 in adult subjects with active ulcerative colitisEUCTR2020-002306-12-PLGB004, Inc.195
进行中（未招募）
1 期
Proof of concept study of rilzabrutinib in adult patients with moderate-to-severe atopic dermatitisAtopic dermatitisEUCTR2021-001704-15-CZSanofi aventis recherche et developpement93
进行中（未招募）
1 期
A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSAmyotrophic Lateral SclerosisMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2019-003797-10-ITAPELLIS PHARMACEUTCIALS, INC.228
进行中（未招募）
1 期
Phase 2 study to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisCTIS2023-509371-16-00Glaxosmithkline Research & Development Limited150
尚未招募
2 期
A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)NL-OMON54376Apellis Pharmaceuticals, Inc12