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A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

NCT02965573•argenx

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.

Detailed Description

Myasthenia Gravis (MG) is an autoimmune disorder characterized in most cases by T cell and antibody responses to neuromuscular junction proteins such as skeletal muscle nicotinic acetylcholine receptor (AChR). Antibodies against epitopes of the AChR of the neuromuscular junction cause failure of neuromuscular transmission, resulting in the characteristic fatigue and weakness associated with this severe disorder. The study will evaluate an innovative candidate in MG.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).
•2. Male or female patients aged ≥18 years.
•3. Diagnosis of autoimmune MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II, III, or IVa, and likely not in need of a respirator for the duration of the study as judged by the Investigator.
•The confirmation of the diagnosis should be documented and supported by:
•* Positive serologic test for anti-AChR antibodies before Screening and
•* at least 1 of the following 3 tests: (i) History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation or (ii) History of positive edrophonium chloride test, or (iii) Patient has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.
•4. A total score of ≥ 5 on the MG ADL at Screening and Baseline with more than 50% of this score attributed to non ocular items.
•5. Patients are required to be on a stable dose of their MG treatment prior to randomization. For patients receiving AZA, other NSIDs, steroids, and/or cholinesterase inhibitors as concomitant medications the following conditions will apply:
•* AZA: treatment initiated at least 12 months ago and no dose changes in the last 6 months before screening.
•* Other NSIDs (e.g., methotrexate, cyclosporine, tacrolimus, mycophenolate mofetil, and cyclophosphamide) treatment initiated at least 6 months ago and no dose changes in the last 3 months before Screening.
+6 more criteria

Exclusion Criteria

•1. Females who are pregnant or lactating.
•2. MGFA Class I, IVb, and V.
•3. Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to Screening; or history of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies, and a negative QuantiFERON®-TB Gold test at Screening. Patients with an indeterminate QuantiFERON®-TB Gold test result will be allowed one retest; if not negative on retesting, the patient will be excluded.
•4. At Screening, have clinically significant laboratory abnormalities or as below:
•* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 x upper limit of normal (ULN).
•* Total serum bilirubin of \> 1.5 x ULN (except for Grade 1 hyperbilirubinemia solely due to a medical diagnosis of Gilbert's syndrome).
•* Serum creatinine \> 1.5 mg/dL and creatinine clearance \< 50 ml/min (using the Chronic Kidney Disease Epidemiology \[CKD-EPI\]-Creatinine formula).
•* Clinically Significant proteinuria (i.e., \> 3 x ULN).
•* Hemoglobin ≤ 9 g/L.
•* Thyroid stimulating hormone or thyroglobulin outside of the central laboratory normal range.
+14 more criteria

Locations (19)

Investigator Site 19

Irvine, California, United States

Investigator Site 17

Los Angeles, California, United States

Investigator Site 15

Tampa, Florida, United States

Investigator Site 16

Indianapolis, Indiana, United States

Investigator Site 14

Chapel Hill, North Carolina, United States

Investigator Site 18

Dublin, Ohio, United States

Investigator Site 2

Ghent, Belgium

Investigator Site 1

Leuven, Belgium

Investigator Site 4

Montreal, Canada

Investigator Site 3

Toronto, Canada

Key Dates

Start Date

December 30, 2016

Primary Completion Date

October 20, 2017

Completion Date

October 20, 2017

Last Updated

August 28, 2024

Enrollment

ACTUAL participants

Conditions

Myasthenia Gravis

Interventions

ARGX-113

BIOLOGICAL

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Inclusion Criteria

Exclusion Criteria

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