Status:
COMPLETED
Multiple Doses of AT-1501-A201 in Adults With ALS
Lead Sponsor:
Anelixis Therapeutics, LLC
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Sclero...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04322149
Start Date
October 16 2020
End Date
March 24 2022
Last Update
June 28 2023
Active Locations (13)
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1
Barrows Neurological Institute
Phoenix, Arizona, United States, 85013
2
University of California Irvine
Orange, California, United States, 92868
3
California Pacific Medical Center
San Francisco, California, United States, 94109
4
Augusta University
Augusta, Georgia, United States, 30912