HEALEY ALS Platform Trial - Regimen G DNL343

Last updated: January 31, 2025
Sponsor: Merit E. Cudkowicz, MD
Overall Status: Completed

Phase

2/3

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

DNL343

Matching Placebo

Clinical Study ID

NCT05842941
2019P003518G
  • Ages 18-100
  • All Genders

Study 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 G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No additional inclusion criteria beyond the inclusion criteria specified in theMaster Protocol (NCT NCT04297683).

Exclusion

Exclusion Criteria:

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

  1. Diagnosis of epilepsy or seizure within 6 months of randomization

  2. Hypersensitivity to DNL343 or any of the excipients contained within the DNL343drug product

  3. The concomitant use of prescription or over-the-counter (OTC) medications thatare inducers of certain cytochrome P450 enzymes, substrates of certaincytochrome P450 enzymes, or substrates of certain drug transporters.

Study Design

Total Participants: 249
Treatment Group(s): 2
Primary Treatment: DNL343
Phase: 2/3
Study Start date:
May 24, 2023
Estimated Completion Date:
October 29, 2024

Study 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 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 G DNL343, the participant will complete a screening visit to assess additional Regimen G eligibility criteria. Once Regimen G eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active DNL343 or matching placebo.

Regimen G will enroll by invitation, as participants may not choose to enroll in Regimen G. 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 G.

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

Connect with a study center

  • Healey Center for ALS at Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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