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Quick Info
Status
Currently Recruiting
Phase
2
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
Open label trial
Enrollment
54
Start Date
10/16/2020
Contact Information
Locations
United States, Arizona
Barrows Neurological Institute, Phoenix, AZ, 85013, United States
Contact: Research Staff   602-406-4232   stephanie.Strong@dignityhealth.org
United States, California
University of California Irvine, Orange, CA, 92868, United States
Contact: Research Staff   714-509-2661   eonv@hs.uci.edu
California Pacific Medical Center, San Francisco, CA, 94109, United States
Contact: Research Staff   415-600-3758   EngelM@cpmcri.org
United States, Georgia
Augusta University, Augusta, GA, 30912, United States
Contact: Research Staff   706-721-2681   BQUARLES@augusta.edu
United States, Indiana
University of Indiana, Indianapolis, IN, 46202, United States
Contact: Research Staff   317-963-7382   sguingri@iu.edu
United States, Kansas
The University of Kansas Medical Center, Kansas City, KS, 66160, United States
Contact: Research study Staff   913-945-9922   ksims2@kumc.edu
United States, Maryland
Johns Hopkins University Medical Center, Baltimore, MD, 21287, United States
Contact: Research Staff   410-955-8511   kriley15@jhmi.edu
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
Contact: Research study Staff   617-643-7428   ZSCHEIER@mgh.harvard.edu
United States, New York
Hospital for Special Surgery (HSS), New York, NY, 10021, United States
Contact: Research Staff   646-797-8592   HolzbergS@hss.edu
United States, Oregon
Providence Brain & Spine Institute, Portland, OR, 97213, United States
Contact: Research Study Staff   503-962-1171   arlena.cummings@providence.org
United States, Texas
Houston Methodist Neurological Institute, Houston, TX, 77030, United States
Contact: Research Staff   713-441-9120   rgapplegate@houstonmethodist.org
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
60%
Months Since Onset
Number of months since first symptoms of ALS.
<24months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
NO
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Open Label
Yes
Update Notes
Contacts updated
4/21/2021
No significant updates
3/16/2021
New site added
2/25/2021
No significant updates
1/22/2021
Doses increased
1/15/2021
New sites added, various other small changes
1/5/2021
Trial recruiting
10/22/2020
No significant updates.
7/8/2020
Trial Added
3/24/2020

Other Information

Purpose
This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 ALS treatment sites. Participants will be enrolled into one of four ascending doses.
Eligibility
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.
4. Able and willing to give informed consent, follow trial procedures, and make multiple clinical site visits.
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.
Details
This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 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.
Collaborator(s)
  • Anelixis Therapeutics, LLC
Trial Protocol as Published on Clinicaltrials.gov
NCT04322149 (First Published: 3/20/2020)