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

NCT ID: NCT05740813

Last Updated: 2025-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2024-10-03

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 F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.

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 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.

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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ALS Placebo-Controlled Double-Blind Regimen Specific Appendix Lou Gehrig's Disease ABBV-CLS-7262 Calico Life Sciences

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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ABBV-CLS-7262 Dose 1

Group Type EXPERIMENTAL

ABBV-CLS-7262 Dose 1

Intervention Type DRUG

ABBV-CLS-7262 is administered orally once per day for 24 weeks.

ABBV-CLS-7262 Dose 2

Group Type EXPERIMENTAL

ABBV-CLS-7262 Dose 2

Intervention Type DRUG

ABBV-CLS-7262 is administered orally once per day for 24 weeks.

Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Matching placebo is administered orally once per day for 24 weeks.

Interventions

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ABBV-CLS-7262 Dose 1

ABBV-CLS-7262 is administered orally once per day for 24 weeks.

Intervention Type DRUG

ABBV-CLS-7262 Dose 2

ABBV-CLS-7262 is administered orally once per day for 24 weeks.

Intervention Type DRUG

Matching Placebo

Matching placebo is administered orally once per day for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

1. Based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome P450 enzymes.
2. Any clinically significant ECG abnormalities.
3. Clinically significant clinical laboratory abnormalities.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calico Life Sciences LLC

INDUSTRY

Sponsor Role collaborator

Merit E. Cudkowicz, MD

OTHER

Sponsor Role lead

Responsible Party

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Merit E. Cudkowicz, MD

Chief, Neurology Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Merit Cudkowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Healey Center for ALS at Mass General

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019P003518F

Identifier Type: -

Identifier Source: org_study_id