Multiple Doses of AT-1501-A201 in Adults With ALS
A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS
1 other identifier
interventional
54
2 countries
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
October 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
1.4 years
March 20, 2020
May 10, 2023
June 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability
Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Up to 18 Weeks
Safety and Tolerability
Incidence of adverse events (AEs) reported as number of TEAEs (Treatment Emergent Adverse Events) having occurred.
Up to 18 Weeks
Study Arms (1)
AT-1501
EXPERIMENTAL4 sequential dose cohorts
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Barrows Neurological Institute
Phoenix, Arizona, 85013, United States
University of California Irvine
Orange, California, 92868, United States
California Pacific Medical Center
San Francisco, California, 94109, United States
Augusta University
Augusta, Georgia, 30912, United States
University of Indiana
Indianapolis, Indiana, 46202, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Hospital for Special Surgery (HSS)
New York, New York, 10021, United States
Providence Brain & Spine Institute
Portland, Oregon, 97213, United States
Texas Neurology, P.A.
Dallas, Texas, 75206, United States
Houston Methodist Neurological Institute
Houston, Texas, 77030, United States
Montreal Neurological Institute and Hospital
Montreal, H3A 2B4, Canada
Related Publications (1)
Perrin S, Ladha S, Maragakis N, Rivner MH, Katz J, Genge A, Olney N, Lange D, Heitzman D, Bodkin C, Jawdat O, Goyal NA, Bornstein JD, Mak C, Appel SH, Paganoni S. Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial. PLoS Med. 2024 Oct 31;21(10):e1004469. doi: 10.1371/journal.pmed.1004469. eCollection 2024 Oct.
PMID: 39480764DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Batterman
- Organization
- Eledon Pharmaceuticals
Study Officials
- STUDY CHAIR
Jeff Bornstein, MD
Eledon Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 26, 2020
Study Start
October 16, 2020
Primary Completion
March 24, 2022
Study Completion
March 24, 2022
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06