Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

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

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.

Keywords

Amyotrophic Lateral Sclerosis ALS Lou Gehirg's Disease motor neuron disease motor neuron degeneration AT-1501 humanized blocking antibody to CD40LG CD40LG inhibitor monoclonal antibody

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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:
  5. Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia),
  6. 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,
  7. 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.
  8. Recipient of Stem Cell or Gene Therapy.
  9. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
  10. History of deep venous thrombosis or pulmonary embolism.
  11. History of active substance abuse within the past 2 years;
  12. History of stroke, poorly controlled or significant cardiovascular disease, diabetes.

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Barrows Neurological Institute accepting new patients
    Phoenix Arizona 85013 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Anelixis Therapeutics, Inc.
ID
NCT04322149
Phase
Phase 2
Study Type
Interventional
Last Updated