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Monoclonal Antibodies
ARGX-119 for ALS (ReALiSe Trial)
Phase 2
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant is at least 18 and ≤80 years of age
The participant is diagnosed with familial or sporadic ALS according to Gold Coast criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will test the safety and effectiveness of a drug called ARGX-119 on adults with ALS. Participants will receive different doses of the drug or a placebo in the first phase of the study,
Who is the study for?
This trial is for adults aged 18 to 80 with ALS, who have a specific risk profile and at least 60% normal lung function. It's open to those with familial or sporadic ALS as per Gold Coast criteria.
What is being tested?
The study tests ARGX-119's safety and its effect on muscle function in ALS patients. Participants will receive either ARGX-119 or a placebo during the treatment period, followed by an extension where all get ARGX-119.
What are the potential side effects?
While the side effects of ARGX-119 are being studied, common risks may include reactions at the injection site, fatigue, headache, and potential immune system responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have been diagnosed with ALS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ARGX-119 - Dose 3Experimental Treatment1 Intervention
Participants will receive third dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period
Group II: ARGX-119 - Dose 2Experimental Treatment1 Intervention
Participants will receive second dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period
Group III: ARGX-119 - Dose 1Experimental Treatment1 Intervention
Participants will receive first dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period
Group IV: PlaceboPlacebo Group2 Interventions
Participants will receive placebo intravenously during the double-blinded treatment period followed by ARGX-119 in active treatment extension period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARGX-119
2023
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
72 Previous Clinical Trials
11,056 Total Patients Enrolled