HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262

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

Phase

2/3

Condition

Myasthenia Gravis (Chronic Weakness)

Amyotrophic Lateral Sclerosis (Als)

Treatment

ABBV-CLS-7262 Dose 1

Matching Placebo

ABBV-CLS-7262 Dose 2

Clinical Study ID

NCT05740813
2019P003518F
  • 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 F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, 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. Based on the metabolism of the compound, the concomitant use of certaininhibitors and inducers of cytochrome P450 enzymes.

  2. Any clinically significant ECG abnormalities.

  3. Clinically significant clinical laboratory abnormalities.

Study Design

Total Participants: 310
Treatment Group(s): 3
Primary Treatment: ABBV-CLS-7262 Dose 1
Phase: 2/3
Study Start date:
March 23, 2023
Estimated Completion Date:
October 03, 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 F ABBV-CLS-7262, the participant will complete a screening visit to assess additional Regimen F eligibility criteria.

Once Regimen F eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in an overall 3:1 ratio to either active ABBV-CLS-7262 or matching placebo. The first 240 participants will be assigned in a 2:1:1 allocation ratio to Dose 1 ABBV-CLS-7262, Dose 2 ABBV-CLS-7262, or placebo. The final approximately 60 participants will be assigned in a 3:1 allocation ratio to Dose 1 ABBV-CLS-7262 or placebo.

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

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 Mass General

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Healey Center for ALS at Mass General

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.