MedTrace Logo

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

NCT05740813 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-11-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

ABBV-CLS-7262 Dose 1

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

DRUG

ABBV-CLS-7262 Dose 2

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

DRUG

Matching Placebo

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

Sponsors & Collaborators

  • Calico Life Sciences LLC

    collaborator INDUSTRY

  • Merit E. Cudkowicz, MD

    lead OTHER

Principal Investigators

  • Merit Cudkowicz, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2024-10-03
Completion
2024-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740813 on ClinicalTrials.gov