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

Merit E. Cudkowicz, MD

Status and phase

Completed

Phase 3

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Matching Placebo

Drug: ABBV-CLS-7262 Dose 1

Drug: ABBV-CLS-7262 Dose 2

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05740813

2019P003518F

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.