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ARDA: 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

Sponsor
argenx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05225675
Collaborator
(none)
48
Enrollment
21
Locations
2
Arms
22.5
Anticipated Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

Condition or Disease Intervention/Treatment Phase
  • Biological: ARGX-117
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
Actual Study Start Date :
Mar 31, 2022
Anticipated Primary Completion Date :
May 11, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARGX-117

Intravenous administration of ARGX-117

Biological: ARGX-117
Intravenous administration of ARGX-117
Placebo Comparator: Placebo

Intravenous administration of placebo

Other: Placebo
Intravenous administration of placebo

Outcome Measures

Primary Outcome Measures

  1. Safety outcomes based on adverse event (AE) monitoring and other safety assessments [16 weeks]

Secondary Outcome Measures

  1. Time to the first retreatment with IVIg since the final IVIg treatment of the IVIg monitoring period [16 weeks]

  2. Difference between the time to the first retreatment with IVIg (cycle) and the second time to retreatment with IVIg [16 weeks]

  3. AUC (area under curve) of the change from baseline in mMRC (modified Medical Research Council)-10 sum score [16 weeks]

  4. Change from baseline in the 2 most important muscle groups as assessed by the mMRC (modified Medical Research Council)-14 sum score [16 weeks]

  5. Value baseline in the mMRC (modified Medical Research Council)-14 sum score [16 weeks]

  6. Change from baseline in the mMRC (modified Medical Research Council)-14 sum score [16 weeks]

  7. Proportion of participants showing a deterioration of 1 or more points in at least 2 muscle groups as assessed by the mMRC (modified Medical Research Council)-14 sum score [16 weeks]

  8. Proportion of participants with no deterioration in 2 or more muscle groups as assessed by mMRC (modified Medical Research Council)-14 sum score [16 weeks]

  9. AUC (area under curve) of the change from baseline in GS (grip strength) [16 weeks]

  10. Proportion of participants with a GS (grip strength) decrease of 8 kilopascal (kPa) or more over 3 consecutive days [16 weeks]

  11. Values baseline in GS (grip strength) [16 weeks]

    The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.

  12. Change from baseline in GS (grip strength) [16 weeks]

    The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.

  13. Percent change from baseline in GS (grip strength) [16 weeks]

    The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.

  14. Values baseline in the Rasch-built overall disability scale for MMN (MMN-RODS©) [16 weeks]

  15. Change from baseline in the Rasch-built overall disability scale for MMN (MMN-RODS©) [16 weeks]

  16. Values baseline in upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed Peg Board Test) [16 weeks]

  17. Change from baseline in upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed Peg Board Test) [16 weeks]

  18. Serum titer levels of binding antibodies (BAbs) against ARGX-117 [16 weeks]

  19. Change from baseline in free C2, total C2, functional complement activity (CH50) [16 weeks]

  20. Values baseline in free C2, total C2, functional complement activity (CH50) [16 weeks]

  21. Area Under The Curve (AUC) [16 weeks]

  22. Maximum serum concentrations (Cmax) [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Capable of giving signed informed consent form (ICF)

  2. Male/female at least 18 years of age at the time the informed consent form (ICF) is signed

  3. Probable or definite MMN according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) (EFNS/PNS) 2010 guidelines at screening confirmed by the MMN Confirmation Committee (MCC)

  4. Receiving a stable IVIg regimen before screening

  5. IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC)

  6. Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted

  7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

  1. Any coexisting condition which may interfere with the outcome assessments

  2. Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies

  3. Severe psychiatric disorder, history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol.

  4. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP).

  5. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE).

  6. History of malignancy unless resolved by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible:

  7. Adequately treated basal cell or squamous cell skin cancer

  8. Carcinoma in situ of the cervix

  9. Carcinoma in situ of the breast

  10. Incidental histological finding of prostate cancer

  11. Clinical evidence of other significant serious diseases, have had a recent major surgery (including a splenectomy at any time), 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

  12. Prior/concomitant therapy

  13. Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening

  14. Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP.

  15. Positive serum test at screening for an active viral infection with any of the following conditions:

  16. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection

  17. Hepatitis C virus (HCV) based on HCV antibody assay

  18. HIV based on test results that are associated with an AIDS-defining condition

  19. Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse

  20. Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients

  21. Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 12 months after last dose of the IMP

  22. ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range

  23. An estimated glomerular filtration rate of ≤60 mL/min/1.73m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigator site 19-US0010013 Scottsdale Arizona United States 85251
2 Investigator Site 8 - US0010071 San Francisco California United States 94109
3 Investigator site 1 - US0010068 Maitland Florida United States 32751
4 Investigator Site 7 - US0010143 Glenview Illinois United States 60026
5 Investigator site 20-US0010126 Minneapolis Minnesota United States 55414
6 Investigator Site 9 - US0010019 Cleveland Ohio United States 44195
7 Investigator site 2 - US0010066 Austin Texas United States 78756
8 Investigator site 21-US0010135 Morgantown West Virginia United States 26506
9 Investigator site 11-AT0430012 Vienna Austria 1090
10 Investigator Site 4 - BE0320027 Ghent Belgium 9000
11 Investigator site 12-FR0330037 Bordeaux France 33076
12 Investigator site 13-FR0330042 Lille France 59037
13 Investigator site 15-FR0330038 Nice France 06001
14 Investigator site 14-FR0330039 Paris France 75651
15 Investigator site 16-IT0390057 Milan Italy 20132
16 Investigator site 10-NL0310013 Utrecht Netherlands 3584 CX
17 Investigator site 3 - PL0480043 Kraków Poland 31-426
18 Investigator Site 5 - SP0340044 Barcelona Spain 08035
19 Investigator site 17-ES0340056 Barcelona Spain 08041
20 Investigator Site 6 - SP0340043 Valencia Spain 46026
21 Investigator site 18-UK0440033 Glasgow United Kingdom G51 4TF

Sponsors and Collaborators

  • argenx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
argenx
ClinicalTrials.gov Identifier:
NCT05225675
Other Study ID Numbers:
  • ARGX-117-2002
First Posted:
Feb 4, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuritis

Study Results

No Results Posted as of Jun 15, 2022