Study Purpose:This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40L. Approximately 54 adults with 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.
Amyotrophic Lateral Sclerosis
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Jeff Bornstein, MD, Eledon Pharmaceuticals
Coordinating Center Contact Information
Full Study Summary:
Four 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.
Anelixis Therapeutics, LLC
Estimated Study Start Date:
10 / 16 / 2020
Estimated Study Completion Date:
03 / 24 / 2022
Posting Last Modified Date:
07 / 14 / 2022
Date Study Added to neals.org:
03 / 26 / 2020
Can participants use Riluzole?
1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria
2. ALSFRS-R Aggregate score of 37 or greater
3. No more than 24 months from diagnosis
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
Barrows Neurological Institute
University of California Irvine
California Pacific Medical Center
San Francisco, California
University of Indiana
The University of Kansas Medical Center
Kansas City, Kansas
Johns Hopkins University Medical Center
Massachusetts General Hospital
Hospital for Special Surgery (HSS)
New York, New York
Providence Brain & Spine Institute
Texas Neurology, P.A.
Houston Methodist Neurological Institute
Montreal Neurological Institute and Hospital
Montreal H3A 2B4