Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2020-10-16
2022-03-24
Brief Summary
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Participants will be enrolled into one of four ascending doses.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AT-1501
4 sequential dose cohorts
AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Interventions
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AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Eligibility Criteria
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Inclusion Criteria
2. ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater
3. No more than 24 months from diagnosis
Exclusion Criteria
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. Tumor necrosis factor alpha (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
18 Years
ALL
No
Sponsors
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Anelixis Therapeutics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Bornstein, MD
Role: STUDY_CHAIR
Eledon Pharmaceuticals
Locations
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Barrows Neurological Institute
Phoenix, Arizona, United States
University of California Irvine
Orange, California, United States
California Pacific Medical Center
San Francisco, California, United States
Augusta University
Augusta, Georgia, United States
University of Indiana
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hospital for Special Surgery (HSS)
New York, New York, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
Texas Neurology, P.A.
Dallas, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Montreal Neurological Institute and Hospital
Montreal, , Canada
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AT-1501-A201
Identifier Type: -
Identifier Source: org_study_id
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