Phase 3
N=310
HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05740813 ↗Enrolled (actual)
310
Serious AEs
11.0%
Results posted
Nov 2025
Primary outcome: Primary: Disease Progression as Assessed by the ALSFRS-R-Slope — -1.00; -0.91; -0.95 Points per month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABBV-CLS-7262 Dose 1 (Drug); ABBV-CLS-7262 Dose 2 (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merit E. Cudkowicz, MD
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Assessed by the ALSFRS-R-Slope |
-1.00; -0.91; -0.95 | — |
| PRIMARY Mortality Event Rate |
0.009; 0.008; 0.009 | — |
| SECONDARY Function by ALSFRS-R Total Score |
-6.110; -5.468; -5.563 | 0.3325 |
| SECONDARY Respiratory Function |
-10.882; -7.202; -9.462 | 0.5008 |
| SECONDARY Upper Limb Muscle Strength |
-36.281; -25.760; -38.078 | 0.6707 |
| SECONDARY Disease Progression Biomarker |
0.086; 0.067; -0.002 | 0.0253 sig |
| SECONDARY Activities of Daily Living |
13.643; 12.049; 13.701 | 0.9782 |
| SECONDARY Number of Participants That Experienced Death or Death Equivalent |
8; 4; 5 | 0.6481 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05740813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.