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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 12, Calgary, AB, T2T5C7, Canada
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
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
France, Other
Annexon Investigational Site 15, Bordeaux, 33076, France
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
Annexon Investigational Site 13, Bron, 69677, France
Contact: Study Coordinator   6508225500   clinicaltrials@annexonbio.com
Annexon Investigational Site 14, Lille, 59037, France
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
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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis (ALS).
Eligibility
Inclusion Criteria:
Subjects must meet all of the following criteria:
1. Males or females aged 18 and above at the time of informed consent.
2. Diagnosis of ALS according to the World Federation of Neurology revised E1 Escorial criteria.
3. Onset of weakness within 3 years prior to enrollment.
4. Slow Vital Capacity ≥ 60% of predicted normal adjusted for sex, age, and height (from the sitting position).
5. Able to perform reproducible pulmonary function tests.
6. ALS concomitant medications stable for at least 2 months prior to Screening.
7. ALSFRS-R ≥ 30 at the Screening Visit.
8. If female, must be postmenopausal, surgically sterilized, or agree to use highly effective methods of contraception from screening through Week 24.
9. Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening through Week 24.
10. Documented history of vaccinations within 5 years prior to screening visit against encapsulated bacterial pathogens.
11. Complete the full sequence of protocol related procedures and evaluations, including lumbar punctures for collection of cerebrospinal fluid.
12. Ability to understand and provide written, informed consent.
Exclusion Criteria:
Subjects must not meet any of the following criteria:
1. Clinically significant, ongoing illness or medical condition that would jeopardize the safety of the subject, limit participation, or compromise the interpretation of the safety data derived from the subject.
2. Subjects with body weight > 150 kg.
3. Clinically significant findings on screening laboratory testing, physical examination or vital signs that are not specific to ALS that could interfere with the conduct of the study, the interpretation of the data or increase subject risk.
4. An ANA titer ≥ 1:160.
5. History of previous infusion reactions, sensitivities, allergic, or anaphylactic reactions to previous medications, environmental stimuli or other substances.
6. Receipt of an experimental agent within 60 days prior to Screening or through Week 24.
7. Prior treatment with any monoclonal antibody within 6 months of screening.
8. Hypersensitivity to any of the excipients in the ANX005 drug product.
9. Clinically significant intercurrent illness, medical condition, or medical history that would jeopardize the safety of the subject, limit participation, or compromise the interpretation of the data derived from the subject.
10. Any known genetic deficiencies of the complement-cascade system.
11. History of chronic systemic steroid use or immunosuppressant medication ending less than 1 month prior to screening.
12. Active alcohol, drug abuse or substance abuse.
13. Females who are pregnant or unwilling to use highly effective methods of contraception.
14. Contraindication to undergoing an LP.
Details
In this Phase 2a, multi-center, open label, proof-of-biology study of ANX005 will be administered to up to approximately 24 subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 12 weeks. Induction Dose: Each subject will receive induction dosing of ANX005 on Days 1 and 5 or 6 (5/6). Maintenance Dose: Each subject will receive a maintenance dose of ANX005 every 2 weeks (Weeks 2, 4, 6, 8, and 10). Maintenance doses are expected to be completed over approximately 4-5 hours. Follow-up visits will be on Weeks 12, 16, and 24. All subjects 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)