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Monoclonal Antibodies
ARGX-117 for Multifocal Motor Neuropathy (ARDA+ 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
Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until marketing authorization of argx-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Awards & highlights
ARDA+ Trial Summary
This trialis designed to assess the safety & effectiveness of ARGX-117 for adults with MMN. It will include double-blind & open-label treatment + safety follow-up.
Who is the study for?
Adults with Multifocal Motor Neuropathy who completed the ARGX-117-2002 trial can join. They must be able to consent, follow the study plan, and use effective contraception. Excluded are those with serious diseases, recent major surgery, other clinical study participation, pregnancy or lactation.Check my eligibility
What is being tested?
The trial tests long-term safety and effectiveness of ARGX-117 for MMN patients. It includes a double-blinded period where some get ARGX-117 and others a placebo, followed by an open-label period where all receive ARGX-117.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at the infusion site, potential infections due to immune response changes from treatment with monoclonal antibodies like ARGX-117.
ARDA+ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished the ARGX-117-2002 trial and can be treated with ARGX-117.
ARDA+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until marketing authorization of argx-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until marketing authorization of argx-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety outcomes based on adverse event (AE) monitoring.
Secondary outcome measures
Area Under The Curve (AUC).
Change from baseline in EQ-5D-5L visual analog scale (VAS).
Change from baseline in free C2, total C2, functional complement activity (CH50).
+32 moreARDA+ Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose regimen 2 or Dose regimen 3Experimental Treatment2 Interventions
ARGX-117/Placebo IV
Group II: Dose regimen 1Experimental Treatment2 Interventions
ARGX-117/Placebo IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARGX-117
2020
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious ongoing infections.I will use birth control until 15 months after my last treatment dose.I finished the ARGX-117-2002 trial and can be treated with ARGX-117.I do not have any serious health conditions that could interfere with the trial.I am a woman who can have children and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Dose regimen 1
- Group 2: Dose regimen 2 or Dose regimen 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health risks have been linked to following Dose regimen 1?
"Taking into account its Phase 2 status, Dosing Regimen 1 was rated a 2 on the safety scale due to limited evidence of efficacy but some supporting data for safety."
Answered by AI
Are medical professionals looking for participants in this trial at present?
"Affirmative. According to clinicaltrials.gov, this medical trial is recruiting potential participants with the original posting date of 18th January 2023 and most recent update on 7th February 2023. The study requires 48 individuals from 3 distinct locations for enrollment."
Answered by AI
Who else is applying?
What site did they apply to?
Investigator site US0010013
What portion of applicants met pre-screening criteria?
Met criteria
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