Randomization and Blinding. This is an open-label study, and therefore all patients will receive eteplirsen.
Randomization and Blinding. Upon determination that a subject meets all eligibility criteria, the subject will be randomized on Study Day -1 to receive either CRV431 or matching placebo in a 2:1 subject ratio (12 CRV431 75mg to 6 matching placebo and 12 CRV431 225mg to 6 matching placebo) in accordance with a computer-generated randomization schedule generated by a non-study statistician. Using this randomization schedule, pharmacy staff or designee will assign treatment sequentially to each eligible subject within a given cohort. This is a single blind study where the investigator and sponsor are unblinded. However, the subject is blinded and will not know if he or she will receive CRV431 or matching placebo.
Randomization and Blinding. This is a randomized, double-blind, placebo-controlled study. To balance the distribution of the standard of care at baseline among the patients, the randomization will be stratified for 3 baseline characteristics, as follows: by region, SLEDAI-2K screening total score (6 to 9 or ≥10), and racial-ethnic group classification (black/Hispanic or others). Within each stratum, eligible patients will be randomly assigned with a 1:1 ratio to receive either 200 mcg of IPP-201101 or placebo sc every 4 weeks for 48 weeks. The randomization code will be generated by ImmuPharma or its designee following specifications from the Biometrics Department. A statistician not assigned to the study will be responsible for review and approval of the randomization code, and the final randomization code will be maintained by ImmuPharma or its designee t. ImmuPharma clinical personnel involved in the study will also be blinded to the study drug identity until the database is locked for analysis and the treatment assignment revealed. Patients will be randomly assigned to treatment through a qualified randomization service provider (eg, interactive response technology [IRT]). Upon receiving the required patient identification, region, SLEDAI-2K screening total score, and racial-ethnic group classification, the IRT will assign the new patient to the next available randomization code within the randomization stratum for the appropriate region, SLEDAI-2K screening total score, and racial- ethnic group classification categories according to the sequence that is specified by ImmuPharma. Patients and investigators will remain blinded to treatment assignment during the study.
Randomization and Blinding. This study is not blinded. In order to minimize allocation bias, the sponsor may use randomized allocation for those patients meeting the eligibility criteria of more than 1 contemporarily enrolling treatment cohort as described in the master protocol.
Randomization and Blinding. 8.6.1. Randomization This is an open-label study and therefore randomization is not applicable.
Randomization and Blinding. This is a randomized double-blind, placebo-controlled study. Participants who meet the entrance criteria will be randomized in a stratified manner based on use of antidepressant treatment (current/stable or not treated/withdrawn ≥30 days) at baseline. Randomization will be done within each stratum in a 1:1 ratio to receive SAGE-217 50 mg or matched placebo. Participants, clinicians, and the study team will be blinded to treatment allocation. Randomization will be performed centrally via an interactive response technology (IRT) system. Randomization schedules will be generated by an independent statistician. The allocation to treatment group will be based on the randomization schedule. The randomization schedules will be kept strictly confidential, accessible only to authorized personnel until the time of unblinding. The blinding of the study will be broken after the database has been locked.
Randomization and Blinding
