- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05405361
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (ARDA+)
April 7, 2024 updated by: argenx
A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
This trial is an extension of the antecedent trial ARGX-117-2002.
It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN).
The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabine Coppieters, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
Study Locations
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Vienna, Austria, 1090
- Active, not recruiting
- Medizinische Universitat Wien (Medical University of Vienna)
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Gent, Belgium, 9000
- Recruiting
- AZ Sint-Lucas
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Contact:
- Jan De Bleecker, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Toronto, Canada
- Recruiting
- University Health Network
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Contact:
- Hans Katzberg, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Bordeaux, France, 33076
- Recruiting
- CHU Bordeaux - Groupe Hospitalier Pellegrin
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Contact:
- Gwendal Le Masson, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Lille, France, 59037
- Not yet recruiting
- Hôpital Roger Salengro (CHU de Lille)
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Contact:
- Céline Tard, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Nice, France, 06001
- Recruiting
- CHU de Nice
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Contact:
- Sabrina Sacconi, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Paris, France, 75651
- Recruiting
- Hopital de la Pitie Salpetriere
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Contact:
- Karine Viala, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Essen, Germany, 45147
- Recruiting
- Universitätsklinikum Essen
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Contact:
- Mark Stettner, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Göttingen, Germany, 37075
- Recruiting
- Universitatsmedizin Gottingen (UMG) Georg-August-Universitaet
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Contact:
- Jana Zschuentzsch, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Milano, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele S.r.l.
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Contact:
- Raffaella Fazio, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
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Contact:
- Gabriele Siciliano, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Rome, Italy, 00189
- Recruiting
- Azienda Ospedaliera Sant' Andrea
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Contact:
- Stefania Morino, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Rozzano, Italy, 20089
- Recruiting
- IRCCS Humanitas Research Hospital
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Contact:
- Eduardo Nobile Orazion, MD
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Utrecht, Netherlands, 3584 CX
- Recruiting
- Universitair Medisch Centrum Utrecht
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Contact:
- Ludo W. van der Pol, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Kraków, Poland, 31-426
- Recruiting
- Michalski i Partnerzy Lekarze Spolka Partnerska
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Contact:
- Krzysztof Banaszkiewicz, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Warsaw, Poland, 02-097
- Recruiting
- Warszawski Uniwersytet Medyczny
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Contact:
- Anna Kostera-Pruszczyk, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d'Hebron
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Contact:
- Raúl Juntas Morales, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau
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Contact:
- Luis Querol, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Valencia, Spain, 46026
- Recruiting
- Hospital Universitari i Politecnic La Fe de Valencia
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Contact:
- Teresa Sevilla Mantecón, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Glasgow, United Kingdom, G51 4TF
- Recruiting
- Queen Elizabeth University Hospital
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Contact:
- Kathryn Brennan, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Oxford, United Kingdom, OX3 9DU
- Recruiting
- Oxford University Hospitals NHS Trust
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Contact:
- Simon Rinaldi, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Arizona
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Scottsdale, Arizona, United States, 85251
- Recruiting
- HonorHealth Neurology
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Contact:
- Todd Levine, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Illinois
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Glenview, Illinois, United States, 60026
- Recruiting
- NorthShore University Healthsystem
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Contact:
- Alexandru Barboi, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- Recruiting
- University of Minnesota
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Contact:
- Jeffrey Allen, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Ohio
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Cleveland, Ohio, United States, 44195
- Recruiting
- The Cleveland Clinic Foundation
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Contact:
- Yuebing Li, MD
- Phone Number: 857-350-4834
- Email: Clinicaltrials@argenx.com
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania - Perelman Center for Advanced Medicine
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Contact:
- Chafic Karam, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Texas
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Austin, Texas, United States, 78759
- Recruiting
- Austin Neuromuscular Center
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Contact:
- Yessar Hussain, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
- Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117
Agrees to use contraceptive measures consistent with local regulations and the following:
- Male participants: must use an acceptable contraceptive method that should be maintained at minimum until 15 months after last dose of Investigational Medicinal Product (IMP).
- Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before Investigational Medicinal Product can be administered.
Exclusion Criteria:
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
- Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
- Currently participating in another interventional clinical study.
- Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the Investigational Medicinal Product.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dose regimen 1
ARGX-117/Placebo IV
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Intravenous administration of ARGX-117
Intravenous administration of placebo
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Experimental: Dose regimen 2 or Dose regimen 3
ARGX-117/Placebo IV
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Intravenous administration of ARGX-117
Intravenous administration of placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety outcomes based on adverse event (AE) monitoring.
Time Frame: Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
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Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Value from baseline in the modified Medical Research Council (mMRC) -10 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in the modified Medical Research Council (mMRC) -10 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants showing a deterioration of at least 2 points in Medical Research Council (mMRC)-10 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
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The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
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Value from baseline in the modified Medical Research Council (mMRC) -14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
Change from baseline in the modified Medical Research Council (mMRC) -14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
Proportion of participants showing a deterioration of at least 2 points in the Medical Research Council (mMRC)-14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants showing a deterioration of 1 or more points in at least 2 muscle groups as assessed by the Medical Research Council (mMRC)-14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
Proportion of participants with no deterioration in 2 or more muscle groups as assessed by Medical Research Council (mMRC)-14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values from baseline in grip strength (GS)
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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GS measurement consists of 3 repeated contractions with the participant's maximal effort.
The duration of each contraction will be 3 seconds.
Each test begins with gripping with the right hand followed by the left.
Measurement of GS will be done using the Martin vigorimeter in kPa.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in grip strength (GS)
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
GS measurement consists of 3 repeated contractions with the participant's maximal effort.
The duration of each contraction will be 3 seconds.
Each test begins with gripping with the right hand followed by the left.
Measurement of GS will be done using the Martin vigorimeter in kPa.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
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Percent change from baseline in grip strength (GS)
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
GS measurement consists of 3 repeated contractions with the participant's maximal effort.
The duration of each contraction will be 3 seconds.
Each test begins with gripping with the right hand followed by the left.
Measurement of GS will be done using the Martin vigorimeter in kPa.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants with a decline of >30% in grip strength (GS).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
GS measurement consists of 3 repeated contractions with the participant's maximal effort.
The duration of each contraction will be 3 seconds.
Each test begins with gripping with the right hand followed by the left.
Measurement of GS will be done using the Martin vigorimeter in kPa.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants with a grip strength (GS) decrease of 8 kilopascals (kPa) or more.
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
GS measurement consists of 3 repeated contractions with the participant's maximal effort.
The duration of each contraction will be 3 seconds.
Each test begins with gripping with the right hand followed by the left.
Measurement of GS will be done using the Martin vigorimeter in kPa.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
Values from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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MMN-RODS© consists of 25 items that are scored 0 (unable to perform), 1 (able to perform, but with difficulty), or 2 (able to perform without difficulty) for each item, yielding a total score from 0 to 50.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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MMN-RODS© consists of 25 items that are scored 0 (unable to perform), 1 (able to perform, but with difficulty), or 2 (able to perform without difficulty) for each item, yielding a total score from 0 to 50.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values from baseline in the average time for the upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed pegboard test).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The 9-HPT is a quantitative measure of upper extremity (arm and hand) function.
Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand).
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in the average time for the upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed pegboard test).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The 9-HPT is a quantitative measure of upper extremity (arm and hand) function.
Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand).
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants by level of severity on each dimension of the Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale.
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Scores for each dimension include 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem.
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Value from baseline in EQ-5D-5L visual analog scale (VAS).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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A vertical VAS is included in the EQ-5D-5L.
Participants mark their health status from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in EQ-5D-5L visual analog scale (VAS).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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A vertical VAS is included in the EQ-5D-5L.
Participants mark their health status from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) includes the assessment of 15 items.
Items will be scored 0 (not at all), 1 (a little bit), or 2 (a lot), yielding a total score that ranges from 0 to 30
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) includes the assessment of 15 items.
Items will be scored 0 (not at all), 1 (a little bit), or 2 (a lot), yielding a total score that ranges from 0 to 30.
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values from baseline in the 9-item Fatigue Severity Scale (FSS).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Fatigue levels are rated from 1 to 7. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement.
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in the 9-item Fatigue Severity Scale (FSS).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Fatigue levels are rated from 1 to 7. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement.
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Proportion of participants by level of severity of MMN as assessed by the Patient Global Impression of Severity (PGIS).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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PGIS is a 7-point scale depicting a participant's rating of overall illness severity.
Higher scores mean a higher severity.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values for work-related and household chore activities of the Health-Related Productivity Questionnaire (HRPQ).
Time Frame: On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The Health-Related Productivity Questionnaire (HRPQ) provides data related to missed hours at work or educational activities and reduced effectiveness during any attempted work.
These criteria form an important portion of work-related productivity and will be used to assess health-related and work-related productivity in the trial.
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On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Area Under The Curve (AUC).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Maximum serum concentrations (Cmax).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Values from baseline in free C2, total C2, functional complement activity (CH50).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Change from baseline in free C2, total C2, functional complement activity (CH50).
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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Incidence of antidrug antibodies (ADA) against ARGX-117.
Time Frame: On day 1, 15, 29, 113 followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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On day 1, 15, 29, 113 followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
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Prevalence of antidrug antibodies (ADA) against ARGX-117.
Time Frame: On day 1, 15, 29, 113 followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
On day 1, 15, 29, 113 followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
|
Value from baseline in the average score of the 2 most important muscle groups as assessed by the Medical Research Council (mMRC)-14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
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The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
Change from baseline in the average score of the 2 most important muscle groups as assessed by the Medical Research Council (mMRC)-14 sum score
Time Frame: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
The mMRC sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs).
The higher the score, the better the muscle strength.
|
On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation
|
Value change as assessed by the Patient Global Impression of Change (PGIC) scale.
Time Frame: On day 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
PGIC is a 7-point scale depicting a participant's rating of overall improvement.
The lower the score, the better the improvement.
|
On day 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2023
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
May 17, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 7, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARGX-117-2003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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