Grants and Contracts Details
Task Oder 6: Regimen A: Zilucoplan - Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis Regimen-Specific Appendix A For 0.3mg/kg SC zilucoplan administered once daily and placebo Allocation to Treatment Regimens Participants must first be screened under the Master Protocol and before they are randomized to an RSA. As soon as pre-defined criteria for futility for the RSA are met, or the target number of randomized participants has been reached, enrollment will stop in the RSA. Number of Planned Participants and Treatment Groups The number of planned participants for this regimen is 160. There are 2 treatment groups for this regimen, active and placebo. Participants will be randomized in a 3:1 ratio to active treatment or placebo (i.e., 120 active : 40 placebo). Planned Number of Sites Research participants will be enrolled from approximately 60 centers in the US. Treatment Duration The maximum duration of the placebo-controlled portion is 24 weeks. Follow-up Duration At the conclusion of the 24-week placebo-controlled period of the study, all participants will either schedule a 40-day follow up safety phone call and end their participation in the regimen or have the option to receive zilucoplan in the Open Label Extension phase of the study. In the Open Label Extension, zilucoplan will be provided by Ra Pharmaceuticals, Inc. until zilucoplan is approved and available in the United States, or Ra Pharmaceuticals, Inc. terminates development of zilucoplan for ALS. Total Planned Trial Duration For participants completing the placebo-controlled treatment period of the study, the planned amount of time in the trial is up to 36 weeks, or about 9 months. This duration assumes a 6-week screening window, a 24-week placebo-controlled treatment period, and a 40-day safety follow-up period for those participants who do not enter the Open Label Extension.
|Effective start/end date||9/4/20 → 2/2/24|
- Massachusetts General Hospital: $8,043.00
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