This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites. Participants will be enrolled into one of four ascending doses.
This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40L. Approximately 54 adults with ALS will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites. Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts. Each participant will receive 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. The study is estimated to take 19 weeks for participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Barrows Neurological Institute
Phoenix, Arizona, United States
University of California Irvine
Orange, California, United States
California Pacific Medical Center
San Francisco, California, United States
Safety and Tolerability
Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Time frame: Up to 18 Weeks
Safety and Tolerability
Incidence of adverse events (AEs) reported as number of TEAEs (Treatment Emergent Adverse Events) having occurred.
Time frame: Up to 18 Weeks
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Augusta University
Augusta, Georgia, United States
University of Indiana
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hospital for Special Surgery (HSS)
New York, New York, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
...and 3 more locations