Study Purpose:
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
ANX005
Placebo:
No
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Benjamin Hoehn, MD, PhD, Annexon, Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Coordinator / email hidden; JavaScript is required / 650-822-5500
United States
Full Study Summary:
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.
Study Sponsor:
Annexon, Inc.
Estimated Enrollment:
24
Estimated Study Start Date:
01 / 15 / 2021
Estimated Study Completion Date:
05 / 31 / 2023
Posting Last Modified Date:
07 / 07 / 2022
Date Study Added to neals.org:
09 / 29 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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.
Annexon Investigational Site 04 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
Phoenix, Arizona
85013
United States
Annexon Investigational Site 01 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
Orange, California
9492868
United States
Annexon Investigational Site 05 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
San Francisco, California
94109
United States
Annexon Investigational Site 02 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
Gainesville, Florida
32608
United States
Annexon Investigational Site 03 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
Tampa, Florida
33612
United States
Annexon Investigational Site 06 | Recruiting
Study Coordinator / 650-822-5500 / email hidden; JavaScript is required
New York, New York
10021
United States
Annexon Investigational Site 10 | Recruiting
Study Coordinator / 6508225500 / email hidden; JavaScript is required
Edmonton, Alberta
T6G 2R7
Canada
Annexon Investigational Site 11 | Recruiting
Study Coordinator / 6508225500 / email hidden; JavaScript is required
Fredericton, New Brunswick
N8 E3B 0C7
Canada
Annexon Investigational Site 09 | Recruiting
Study Coordinator / 6508225500 / email hidden; JavaScript is required
Toronto, Ontario
M4N 3M5
Canada
Annexon Investigational Site 07 | Recruiting
Study Coordinator / 6508225500 / email hidden; JavaScript is required
Montréal, Quebec
H2X 0A9
Canada
Annexon Investigational Site 08 | Recruiting
Study Coordinator / 6508225500 / email hidden; JavaScript is required
Montréal, Quebec
H3A 2B4
Canada