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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 January 2025 |
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Main ID: |
NCT04569435 |
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Date of registration:
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23/09/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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Phase 2a Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Study of Intravenous ANX005 in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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January 15, 2021 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04569435 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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France
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United States
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Contacts
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Name:
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Benjamin Hoehn, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Annexon, Inc. |
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Key inclusion & exclusion criteria
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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 childbearing potential
must agree to use highly effective methods of contraception from Screening until 3
months after the last infusion with study medication.
- Males with a woman partner of childbearing potential must agree to use highly
effective methods of contraception from Screening until Week until 3 months after
the last infusion with study medication.
- 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 intercurrent illness, medical condition, or medical history
that would jeopardize the safety of the participant, limit participation, or
compromise the interpretation of the 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: ANX005
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Primary Outcome(s)
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Number of Participants Who Experienced Treatment-Emergent Adverse Events
[Time Frame: Up to Week 36]
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Secondary Outcome(s)
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Change from Baseline in Free Complement (C) 1q Serum Concentrations
[Time Frame: Baseline, up to Week 36]
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Maximum Observed Serum Concentration (Cmax) of ANX005
[Time Frame: Up to Week 36]
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Serum Concentrations of ANX005
[Time Frame: Up to Week 36]
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Area Under the ANX005 Serum Concentration-Time Curve
[Time Frame: Day 1 and Week 22]
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Secondary ID(s)
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ANX005-ALS-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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