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Monoclonal Antibodies

ARGX-117 for Multifocal Motor Neuropathy (ARDA Trial)

Phase 2
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

ARDA Trial Summary

This trial is testing a new drug, ARGX-117, to see if it is safe and effective in treating a disease called MMN.

Who is the study for?
Adults with Multifocal Motor Neuropathy (MMN) who are stable on IVIg treatment can join this trial. They must be at least 18, have been vaccinated against certain infections, and use approved contraception methods. People with severe psychiatric issues, other serious diseases, recent major surgery, drug abuse history or certain medication use in the last 3 months cannot participate.Check my eligibility
What is being tested?
The trial is testing two different doses of a new drug called ARGX-117 compared to a placebo in people with MMN. It's designed to see if ARGX-117 is safe and works well when added to their regular IVIg therapy. Participants will be randomly assigned to one of the groups without knowing which one they're in.See study design
What are the potential side effects?
Possible side effects from ARGX-117 may include reactions related to the immune system since it targets specific parts of it. The exact side effects aren't listed but could resemble those seen with similar treatments like infusion reactions or increased risk of infections.

ARDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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 and other safety assessments
Secondary outcome measures
AUC (area under curve) of the change from baseline in GS (grip strength)
AUC (area under curve) of the change from baseline in mMRC (modified Medical Research Council)-10 sum score
Area Under The Curve (AUC)
+21 more

ARDA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARGX-117Experimental Treatment1 Intervention
Intravenous administration of ARGX-117
Group II: PlaceboPlacebo Group1 Intervention
Intravenous administration of placebo
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
9,216 Total Patients Enrolled

Media Library

ARGX-117 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05225675 — Phase 2
Multifocal Motor Neuropathy Research Study Groups: ARGX-117, Placebo
Multifocal Motor Neuropathy Clinical Trial 2023: ARGX-117 Highlights & Side Effects. Trial Name: NCT05225675 — Phase 2
ARGX-117 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225675 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are hosting this investigation?

"Patients are invited to enrol in this clinical trial at Investigator site 2 - US0010066 located in Austin, Texas,Investigator Site 22-US0010121 based out of Philadelphia and Pennsylvania, or Investigator Site 7 - US0010143 situated outside Glenview Illinois. Additionally there are 10 other recruiting sites throughout the United States."

Answered by AI

How many participants comprise this research endeavor?

"Affirmative. According to the data readily available on clinicaltrials.gov, this medical study is currently recruiting participants; it was initially announced on March 31st 2022 and has since been revised at least once as of October 31st 2022. The trial necessitates 48 recruits from 10 different sites."

Answered by AI

Are there any remaining opportunities to join this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial initiated on March 31st 2022 is currently enrolling participants. The study requires 48 patients spread across 10 different sites to be recruited before the next update scheduled for October 31st 2022."

Answered by AI

Has ARGX-117 been accepted by the FDA?

"ARGX-117 has attained a score of 2 due to having some evidence for its safety, but no data demonstrating effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
2022. "A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05225675.
All > Neuropathy
~9 spots leftby Oct 2024
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