HEALEY ALS Platform Trial - Regimen A Zilucoplan

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-05-04

Brief Summary

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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.

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Detailed Description

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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 as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen A - Zilucoplan, the participant will complete a screening visit to assess additional Regimen A eligibility criteria. Once Regimen A eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active zilucoplan or matching placebo.

Regimen A will enroll by invitation, as participants may not choose to enroll in Regimen A. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen A.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zilucoplan

Drug: Zilucoplan Administration: Subcutaneous injection

Dosage: 0.3mg/kg administered daily

Group Type EXPERIMENTAL

Zilucoplan

Intervention Type DRUG

Drug: Zilucoplan Administration: Subcutaneous injection

Dosage: 0.3mg/kg administered daily

Matching Placebo

Administration: Subcutaneous injection

Dosage: Daily subcutaneous injection

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Drug: Matching Placebo

Administration: Subcutaneous injection

Dosage: Daily subcutaneous injection

Interventions

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Zilucoplan

Drug: Zilucoplan Administration: Subcutaneous injection

Dosage: 0.3mg/kg administered daily

Intervention Type DRUG

Matching Placebo

Drug: Matching Placebo

Administration: Subcutaneous injection

Dosage: Daily subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.