Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322149
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Eledon Pharmaceuticals ( Anelixis Therapeutics, LLC )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: AT-1501 Phase 2

Detailed Description:

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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS
Actual Study Start Date : October 16, 2020
Actual Primary Completion Date : March 24, 2022
Actual Study Completion Date : March 24, 2022


Arm Intervention/treatment
Experimental: AT-1501
4 sequential dose cohorts
Drug: AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Approx. 5 Months ]
    Incidence of adverse events (AEs) as characterized by changes in physical examination, vital signs, ECG, laboratory parameters, and C-SSRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322149


Locations
Layout table for location information
United States, Arizona
Barrows Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
University of California Irvine
Orange, California, United States, 92868
California Pacific Medical Center
San Francisco, California, United States, 94109
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Indiana
University of Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Hospital for Special Surgery (HSS)
New York, New York, United States, 10021
United States, Oregon
Providence Brain & Spine Institute
Portland, Oregon, United States, 97213
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75206
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Canada
Montreal Neurological Institute and Hospital
Montreal, Canada, H3A 2B4
Sponsors and Collaborators
Anelixis Therapeutics, LLC
Investigators
Layout table for investigator information
Study Chair: Jeff Bornstein, MD Eledon Pharmaceuticals
Layout table for additonal information
Responsible Party: Anelixis Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04322149    
Other Study ID Numbers: AT-1501-A201
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eledon Pharmaceuticals ( Anelixis Therapeutics, LLC ):
ALS
Lou Gehirg's Disease
motor neuron disease
motor neuron degeneration
AT-1501
humanized blocking antibody to CD40LG
CD40L inhibitor
monoclonal antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases