Multiple Doses of AT-1501-A201 in Adults With ALS

NCT04322149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-06-28

Study results available
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Summary

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.

Conditions

Interventions

DRUG

AT-1501

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Sponsors & Collaborators

  • Anelixis Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Jeff Bornstein, MD · Eledon Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2022-03-24
Completion
2022-03-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322149 on ClinicalTrials.gov