HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABBV-CLS-7262 Dose 1
|
Drug: ABBV-CLS-7262 Dose 1
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
| Experimental: ABBV-CLS-7262 Dose 2
|
Drug: ABBV-CLS-7262 Dose 2
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
| Placebo Comparator: Matching Placebo
|
Drug: Matching Placebo
Matching placebo is administered orally once per day for 24 weeks.
|
Outcome Measures
Primary Outcome Measures
- 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
- Muscle Strength [24 Weeks]
Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD) and grip strength.
Other Outcome Measures
- Respiratory Function [24 Weeks]
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Eligibility Criteria
Criteria
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).
-
Based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome P450 enzymes.
-
Any clinically significant ECG abnormalities.
-
Clinically significant clinical laboratory abnormalities.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merit E. Cudkowicz, MD
- Calico Life Sciences LLC
Investigators
- Principal Investigator: Merit Cudkowicz, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P003518F