A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS
Study Purpose:
This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 ALS treatment sites.
Participants will be enrolled into one of three ascending doses.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Steve Perrin, PhD Anelixis Therapeutics, Inc.
Clinicaltrials.gov ID (11 digit #):
NCT04322149Neals Affiliated?
NoCoordinating Center Contact Information
Jennifer Bartoshevich / .(JavaScript must be enabled to view this email address) / 603-320-5141
.(JavaScript must be enabled to view this email address)
Full Study Summary:
This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 ALS treatment sites.
Three 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 Sponsor:
Anelixis Therapeutics, Inc.Participant Duration:
19 weeks