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

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT04322149

Run by

Anelixis Therapeutics, LLC

People needed

54

Starts

2020-10-16

Expected to finish

2022-03-24

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria
• ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater
• No more than 24 months from diagnosis

You may not qualify if…

• Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression
• Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more)
• History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers
• 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. Tumor necrosis factor alpha (TNF α) antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.
• Recipient of Stem Cell or Gene Therapy
• Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
• History of deep venous thrombosis or pulmonary embolism
• History of active substance abuse within the past 2 years
• History of stroke, poorly controlled or significant cardiovascular disease, diabetes

Where it is running

• Barrows Neurological Institute — Phoenix, Arizona, United States
• University of California Irvine — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• 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
• Texas Neurology, P.A. — Dallas, Texas, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• Montreal Neurological Institute and Hospital — Montreal, Canada

Full record on ClinicalTrials.gov

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