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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 ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Steve Perrin, PhD Anelixis Therapeutics, Inc.

Clinicaltrials.gov ID (11 digit #):

NCT04322149

Neals Affiliated?

No

Coordinating 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

Estimated Enrollment:

54

Estimated Study Start Date:

10/16/2020

Estimated Study Completion Date:

10/31/2021

Posting Last Modified Date:

02/01/2021

Date Study Added to alsconsortium.org:

07/14/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria.
    2. FVC (Forced Vital Capacity) equal to or greater than 60%.
    3. No more than 24 months from diagnosis.
    4. Able and willing to give informed consent, follow trial procedures, and make multiple clinical site visits.

    Exclusion Criteria:

    1. Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression.
    2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more).
    3. History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers.
    4. Abnormal function of the immune system resulting from: Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia), Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening, Administration of anti-neoplastic and/or immunomodulating agents (e.g. TNF α antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.
    5. Recipient of Stem Cell or Gene Therapy.
    6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
    7. History of deep venous thrombosis or pulmonary embolism.
    8. History of active substance abuse within the past 2 years;
    9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes.

  • Site Contact Information

    Barrows Neurological Institute
    Research Staff / .(JavaScript must be enabled to view this email address) / 602-406-4232
    Phoenix, Arizona 85013
    United States

    University of California Irvine
    Research Staff / .(JavaScript must be enabled to view this email address) / 714-509-2661
    Orange, California 92868
    United States

    California Pacific Medical Center
    Research Staff / .(JavaScript must be enabled to view this email address) / 415-600-3758
    San Francisco, California 94109
    United States

    Augusta University
    Research Staff / .(JavaScript must be enabled to view this email address) / 706-721-2681
    Augusta, Georgia 30912
    United States

    University of Indiana
    Research Staff / .(JavaScript must be enabled to view this email address) / 317-963-7382
    Indianapolis, Indiana 46202
    United States

    Johns Hopkins University Medical Center
    Research Staff / .(JavaScript must be enabled to view this email address) / 410-955-8511
    Baltimore, Maryland 21287
    United States

    Massachusetts General Hospital
    Research Staff / .(JavaScript must be enabled to view this email address) / 617-643-7428
    Boston, Massachusetts 02114
    United States

    Hospital for Special Surgery
    Research Staff / .(JavaScript must be enabled to view this email address) / 646-797-8592
    New York, New York 10021
    United States

    Providence Brain & Spine Institute
    Research Study Staff / .(JavaScript must be enabled to view this email address) / 503-962-1171
    Portland, Oregon 97213
    United States

    Houston Methodist Neurological Institute
    Research Staff / .(JavaScript must be enabled to view this email address) / 713-441-9120
    Houston, Texas 77030
    United States