NL-OMON54376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) - MERIDIA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 12
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 99（—）
入选标准
- •Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable
- •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
- •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
- •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
- •last dose of investigational product.
- •8. Have vaccination against Streptococcus pneumoniae, Neisseria meningitidis
- •(types A, C,
- •W, Y, and B), and Haemophilus influenzae (type B) either within 5 years prior
- •to baseline
- •visit 2b, or agree to receive vaccination at least 7 days prior to baseline
- •Vaccination is mandatory, unless documented evidence exists that subjects are
- •nonresponders to vaccination (as evidenced by titers or display titer levels
- •acceptable local limits).
- •9. Willing and able to give informed consent and comply with study procedure
- •assessments (including at-home assessments
排除标准
- •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
- •treatments that might complicate the evaluation of the effect of ALS on
- •respiratory
- •function (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic
- •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 of study participation, but the dosage may
- •or the drug discontinued at any time by the investigator for any safety
- •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
- •Edaravone-naïve subjects are allowed in the study.
- •8. Positive response to Item 4 or 5 of the Columbia Suicide Severity Rating
- •9. Subjects with detectable hepatitis C by polymerase chain reaction at
- •10. Subjects with chronic inactive hepatitis B with viral loads >1000 IU/mL
- •copies/mL) at screening. Eligible subjects who are chronic active carriers
- •(<=1000 IU/mL)
- •must receive prophylactic antiviral treatment according to local country
- •(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
- 另有 11 项未显示
研究者
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