Back to resultsA 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+)
Primary Purpose
Multifocal Motor Neuropathy (MMN)
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ARGX-117
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multifocal Motor Neuropathy (MMN)
Eligibility Criteria
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 12 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 12 months after last dose of the Investigational Medicinal Product.
Sites / Locations
- Investigator site US0010013Recruiting
- Investigator site US0010143Recruiting
- Investigator site US0010126Recruiting
- Investigator site US0010019Recruiting
- Investigator site US0010121Recruiting
- Investigator site US0010066Recruiting
- Investigator site AT00430012Recruiting
- Investigator site BE00320027Recruiting
- Investigator site FR00330042
- Investigator site FR00330038Recruiting
- Investigator site FR00330039Recruiting
- Investigator site IT00390057Recruiting
- Investigator site IT00390056Recruiting
- Investigator Site IT00390058Recruiting
- Investigator site PL00480043Recruiting
- Investigator site PL00480045Recruiting
- Investigator site ES00340044Recruiting
- Investigator site ES00340056Recruiting
- Investigator site ES00340043Recruiting
- Investigator site UK00440034Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose regimen 1
Dose regimen 2 or Dose regimen 3
Arm Description
ARGX-117/Placebo IV
ARGX-117/Placebo IV
Outcomes
Primary Outcome Measures
Safety outcomes based on adverse event (AE) monitoring.
Secondary Outcome Measures
Value from baseline in the modified Medical Research Council (mMRC) -10 sum score
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.
Change from baseline in the modified Medical Research Council (mMRC) -10 sum score
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
Proportion of participants showing a deterioration of at least 2 points in Medical Research Council (mMRC)-10 sum score
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.
Value from baseline in the modified Medical Research Council (mMRC) -14 sum score
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.
Change from baseline in the modified Medical Research Council (mMRC) -14 sum score
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.
Proportion of participants showing a deterioration of at least 2 points in the Medical Research Council (mMRC)-14 sum score
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.
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
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.
Proportion of participants with no deterioration in 2 or more muscle groups as assessed by Medical Research Council (mMRC)-14 sum score
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.
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
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.
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
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.
Values from baseline in grip strength (GS)
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.
Change from baseline in grip strength (GS)
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.
Percent change from baseline in grip strength (GS)
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.
Proportion of participants with a decline of >30% in grip strength (GS).
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.
Proportion of participants with a grip strength (GS) decrease of 8 kilopascals (kPa) or more.
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.
Values from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
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.
Change from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
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.
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).
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).
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).
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).
Proportion of participants by level of severity on each dimension of the Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale.
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.
Value from baseline in EQ-5D-5L visual analog scale (VAS).
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).
Change from baseline in EQ-5D-5L visual analog scale (VAS).
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).
Values from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
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
Change from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
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.
Values from baseline in the 9-item Fatigue Severity Scale (FSS).
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.
Change from baseline in the 9-item Fatigue Severity Scale (FSS).
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.
Value change as assessed by the Patient Global Impression of Change (PGIC) scale.
PGIC is a 7-point scale depicting a participant's rating of overall improvement. The lower the score, the better the improvement.
Proportion of participants by level of severity of MMN as assessed by the Patient Global Impression of Severity (PGIS).
PGIS is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity.
Values for work-related and household chore activities of the Health-Related Productivity Questionnaire (HRPQ).
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.
Area Under The Curve (AUC).
Maximum serum concentrations (Cmax).
Values from baseline in free C2, total C2, functional complement activity (CH50).
Change from baseline in free C2, total C2, functional complement activity (CH50).
Incidence of antidrug antibodies (ADA) against ARGX-117.
Prevalence of antidrug antibodies (ADA) against ARGX-117.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05405361
Brief Title
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
Acronym
ARDA+
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multifocal Motor Neuropathy (MMN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
During the double-blinded rollover treatment period (DTP),the investigator, trial nurse/coordinator, participant, and the sponsor's designated contract research organization (CRO), and sponsor trial team (except the sponsor's clinical trial supplies team) are blinded to IMP. The interactive response technology (IRT) system is used for blinding.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose regimen 1
Arm Type
Experimental
Arm Description
ARGX-117/Placebo IV
Arm Title
Dose regimen 2 or Dose regimen 3
Arm Type
Experimental
Arm Description
ARGX-117/Placebo IV
Intervention Type
Biological
Intervention Name(s)
ARGX-117
Intervention Description
Intravenous administration of ARGX-117
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration of placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Value from baseline in the modified Medical Research Council (mMRC) -10 sum score
Description
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.
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.
Title
Change from baseline in the modified Medical Research Council (mMRC) -10 sum score
Description
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
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.
Title
Proportion of participants showing a deterioration of at least 2 points in Medical Research Council (mMRC)-10 sum score
Description
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.
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
Title
Value from baseline in the modified Medical Research Council (mMRC) -14 sum score
Description
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.
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.
Title
Change from baseline in the modified Medical Research Council (mMRC) -14 sum score
Description
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.
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
Title
Proportion of participants showing a deterioration of at least 2 points in the Medical Research Council (mMRC)-14 sum score
Description
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.
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.
Title
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
Description
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.
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
Title
Proportion of participants with no deterioration in 2 or more muscle groups as assessed by Medical Research Council (mMRC)-14 sum score
Description
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.
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.
Title
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
Description
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.
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.
Title
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
Description
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.
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
Title
Values from baseline in grip strength (GS)
Description
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.
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.
Title
Change from baseline in grip strength (GS)
Description
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.
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
Title
Percent change from baseline in grip strength (GS)
Description
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.
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.
Title
Proportion of participants with a decline of >30% in grip strength (GS).
Description
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.
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.
Title
Proportion of participants with a grip strength (GS) decrease of 8 kilopascals (kPa) or more.
Description
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.
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.
Title
Values from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
Description
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.
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.
Title
Change from baseline in the Rasch-built overall disability scale for Multifocal Motor Neuropathy (MMN-RODS©).
Description
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.
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.
Title
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).
Description
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).
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.
Title
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).
Description
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).
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.
Title
Proportion of participants by level of severity on each dimension of the Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale.
Description
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.
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.
Title
Value from baseline in EQ-5D-5L visual analog scale (VAS).
Description
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).
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.
Title
Change from baseline in EQ-5D-5L visual analog scale (VAS).
Description
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).
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.
Title
Values from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
Description
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
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.
Title
Change from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI).
Description
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.
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.
Title
Values from baseline in the 9-item Fatigue Severity Scale (FSS).
Description
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.
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.
Title
Change from baseline in the 9-item Fatigue Severity Scale (FSS).
Description
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.
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.
Title
Value change as assessed by the Patient Global Impression of Change (PGIC) scale.
Description
PGIC is a 7-point scale depicting a participant's rating of overall improvement. The lower the score, the better the improvement.
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.
Title
Proportion of participants by level of severity of MMN as assessed by the Patient Global Impression of Severity (PGIS).
Description
PGIS is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity.
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.
Title
Values for work-related and household chore activities of the Health-Related Productivity Questionnaire (HRPQ).
Description
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.
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
ClinicalTrials@argenx.com
Facility Information:
Facility Name
Investigator site US0010013
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010143
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010126
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010019
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site US0010121
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010066
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site AT00430012
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site BE00320027
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site FR00330042
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site FR00330038
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site FR00330039
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site IT00390057
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site IT00390056
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site IT00390058
City
Rome
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site PL00480043
City
Kraków
ZIP/Postal Code
31-426
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site PL00480045
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES00340044
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site ES00340056
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site ES00340043
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site UK00440034
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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