Status:
COMPLETED
HEALEY ALS Platform Trial - Regimen A Zilucoplan
Lead Sponsor:
Merit E. Cudkowicz, MD
Collaborating Sponsors:
Ra Pharmaceuticals
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen A will evaluat...
Detailed Description
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed ...
Eligibility Criteria
Inclusion
- The following inclusion criterion is in addition to the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
- Vaccination with a quadrivalent meningococcal vaccine and meningococcal serotype B vaccine at least 14 days prior to the first dose of study drug at the Baseline (Day 0) visit. Meningococcal vaccines (including boosters) should be administered in accordance with the study's vaccination worksheet.
Exclusion
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
- History of meningococcal disease.
- Prior treatment with a complement inhibitor.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04436497
Start Date
July 29 2020
End Date
May 4 2022
Last Update
July 25 2023
Active Locations (1)
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1
Healey Center for ALS at Mass General
Boston, Massachusetts, United States, 02114