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Clinical trial

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

ID
Name
2019P003518F
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. Regimen F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.
Trial arms
Trial start
2023-03-23
Estimated PCD
2024-09-01
Trial end
2024-10-01
Phase
Early phase I
Treatment
ABBV-CLS-7262 Dose 1
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
Arms:
ABBV-CLS-7262 Dose 1
ABBV-CLS-7262 Dose 2
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
Arms:
ABBV-CLS-7262 Dose 2
Matching Placebo
Matching placebo is administered orally once per day for 24 weeks.
Arms:
Matching Placebo
Size
300
Primary endpoint
Disease Progression
24 Weeks
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). 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-10-17

1 organization

2 products

1 indication

Organization
Merit E. Cudkowicz, MD
Product
ABBV-CLS-7262
Indication
Amyotrophic lateral sclerosis
Product
Matching Placebo