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Quick Info
Status
Currently Recruiting
Phase
2
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
Open label trial
Enrollment
24
Start Date
1/15/2021
Sponsor
Contact Information
    Contact information unknown.
Locations
Canada, Alberta
Annexon Investigational Site 10, Edmonton, AB, T6G 2R7, Canada
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
Canada, New Brunswick
Annexon Investigational Site 11, Fredericton, NB, N8 E3B 0C7, Canada
Contact: Study Coordinator   6508225500   Clinicaltrials@annexonbio.com
Canada, Ontario
Annexon Investigational Site 09, Toronto, ON, M4N 3M5, Canada
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
Canada, Quebec
Annexon Investigational Site 07, Montréal, QC, H2X 0A9, Canada
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
Annexon Investigational Site 08, Montréal, QC, H3A 2B4, Canada
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
United States, Arizona
Annexon Investigational Site 04, Phoenix, AZ, 85013, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
United States, California
Annexon Investigational Site 01, Orange, CA, 9492868, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
Annexon Investigational Site 05, San Francisco, CA, 94109, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
United States, Florida
Annexon Investigational Site 02, Gainesville, FL, 32608, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
Annexon Investigational Site 03, Tampa, FL, 33612, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
United States, New York
Annexon Investigational Site 06, New York, NY, 10021, United States
Contact: Study Coordinator   650-822-5500   clinicaltrials@annexonbio.com
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
(SVC) ≥60%
Months Since Onset
Number of months since first symptoms of ALS.
3 years
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
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?
Yes
Open Label
No
Update Notes
Completion date/protocol updates
7/8/2022
Contact updated
11/30/2021
Completion date, protocol, and site updates
10/7/2021
New sites added
5/13/2021
Study recruiting
3/24/2021
No longer recruiting
10/20/2020
Study recruiting
10/6/2020

Other Information

Purpose
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
Eligibility
Key Inclusion Criteria:
- Diagnosis of ALS according to the World Federation of Neurology revised EI Escorial criteria.
- Onset of weakness within 3 years prior to Day 1 visit.
- Slow Vital Capacity ≥ 50% of predicted normal adjusted for sex, age, and height (from the sitting position).
- ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at the Screening visit (Week -2).
- If female, must be postmenopausal, surgically sterilized, or agree to use highly effective methods of contraception from Screening through Week 36.
- Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening through Week 36.
- Documented history of vaccinations within 5 years prior to Screening visit against encapsulated bacterial pathogens or willing to undergo vaccinations.
Key Exclusion Criteria:
- Clinically significant, ongoing or intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety data derived from the participant.
- Participants with body weight > 150 kilograms.
- Antinuclear antibodies (ANA) titer ≥ 1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) during the Screening Period.
Details
In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS. The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.
Collaborator(s)
  • Annexon, Inc.
Trial Protocol as Published on Clinicaltrials.gov
NCT04569435 (First Published: 9/23/2020)