drugset / Trial / NCT04436497
HEALEY ALS Platform Trial - Regimen A Zilucoplan
RandomizedParallel-groupQuadruple-blindTreatment
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 A will evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with ALS.
Timeline
- Start
- 2020-07-29
- Primary completion
- 2022-04-13
- Completion
- 2022-05-04
Outcome
Missed primary endpoint
registry Disease Rate Ratio 1.08 (95% CI 0.874 to 1.307) NCT04436497 ↗
registry Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NCT04436497 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zilucoplan | Peptide | 0.3 mg/kg | Subcutaneous |