Overview

HEALEY ALS Platform Trial - Regimen A Zilucoplan

Status:
Enrolling by invitation

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

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 evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with ALS.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Merit E. Cudkowicz, MD

Collaborator:

Ra Pharmaceuticals

Criteria

Inclusion Criteria:

- The following inclusion criterion is in addition to the inclusion criteria specified
in the Master Protocol (NCT NCT04297683).

1. 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 Criteria:

- The following exclusion criteria are in addition to the exclusion criteria specified
in the Master Protocol (NCT NCT04297683).

1. History of meningococcal disease.

2. Prior treatment with a complement inhibitor.