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

Phase 2

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: ABBV-CLS-7262 Dose 1; Drug: ABBV-CLS-7262 Dose 2; Drug: Matching Placebo

• Registration Number: NCT05740813
• Lead Sponsor: Merit E. Cudkowicz, MD

Brief 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.

Detailed 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 a 3:1 ratio to either active ABBV-CLS-7262 or matching 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.

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-23
• Study Start: 2023-03-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-14
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

  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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABBV-CLS-7262 Dose 1	ABBV-CLS-7262 Dose 1	-
ABBV-CLS-7262 Dose 2	ABBV-CLS-7262 Dose 2	-
Matching Placebo	Matching Placebo	-

Primary Outcome Measures

Name	Time	Method
Disease Progression	24 Weeks	Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score and mortality. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.

Secondary Outcome Measures

Name	Time	Method
Muscle Strength	24 Weeks	Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD) and grip strength.
Respiratory Function	24 Weeks	Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Disease Progression Biomarker	24 Weeks	Change in disease progression as measured by serum neurofilament light chain (NfL).

Trial Locations

Locations (1)

Healey Center for ALS at Mass General; 🇺🇸 Boston, Massachusetts, United States