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COMPLETED Phase 2

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

NCT04322149 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG AT-1501

Study Locations (13)

California

  • University of California Irvine — Orange
  • California Pacific Medical Center — San Francisco

Texas

  • Texas Neurology, P.A. — Dallas
  • Houston Methodist Neurological Institute — Houston

Arizona

  • Barrows Neurological Institute — Phoenix

Georgia

  • Augusta University — Augusta

Indiana

  • University of Indiana — Indianapolis

Kansas

  • The University of Kansas Medical Center — Kansas City

Maryland

  • Johns Hopkins University Medical Center — Baltimore

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2020-10-16
Est. Completion 2022-03-24
Phase Phase 2

Sponsor

Anelixis Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04322149

The ClinicalTrials.gov registry entry for NCT04322149 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anelixis Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which AT-1501 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04322149 reports 13 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04322149 about?

NCT04322149 is a clinical study titled "Multiple Doses of AT-1501-A201 in Adults With ALS". 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 tr...

What is the current status of trial NCT04322149?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2020-10-16. Estimated completion is 2022-03-24.

What conditions does trial NCT04322149 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04322149?

The interventions under investigation include: AT-1501 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04322149?

This trial is sponsored by Anelixis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04322149 being conducted?

This trial has 13 study locations across Arizona, California, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial