Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-CLS-7262 Dose 1 · 1 trial · 1 indication
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each of 12 questions assessing distinct functional ability is scored from 4(normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function. Note that only participants who survived to their Week 24 visit contribute to the estimate.
Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.
| Arm | Type | Description |
|---|---|---|
| ABBV-CLS-7262 Dose 1 | EXPERIMENTAL | - |
| ABBV-CLS-7262 Dose 2 | EXPERIMENTAL | - |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-7262 Dose 1 | DRUG | ABBV-CLS-7262 is administered orally once per day for 24 weeks. |
| ABBV-CLS-7262 Dose 2 | DRUG | ABBV-CLS-7262 is administered orally once per day for 24 weeks. |
| Matching Placebo | DRUG | Matching placebo is administered orally once per day for 24 weeks. |
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...
ABBV-CLS-7262 Dose 1 is an investigational small molecule being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is being evaluated in a Phase 2 clinical trial as part of the HEALEY ALS Platform Trial. The drug is not yet approved and remains in clinical development.
ABBV-CLS-7262 Dose 1 is being developed by Merit Medical Systems, Inc., which trades on the NASDAQ under the ticker MMSI. The company is conducting a Phase 2 clinical trial of the drug for Amyotrophic Lateral Sclerosis.
ABBV-CLS-7262 Dose 1 is in Phase 2 clinical development. It is an investigational drug for Amyotrophic Lateral Sclerosis and has not been approved by regulatory authorities. The Phase 2 trial, NCT05740813, has been completed.
ABBV-CLS-7262 Dose 1 is being studied in the HEALEY ALS Platform Trial, specifically Regimen F, under the clinical trial identifier NCT05740813. This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 310 participants with Amyotrophic Lateral Sclerosis in the United States. The trial has been completed.
ABBV-CLS-7262 Dose 1 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Amyotrophic Lateral Sclerosis. The completed clinical trial NCT05740813 was designed to evaluate its safety and efficacy, but the drug has not received regulatory approval.