Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

Completed · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia Gravis (MG).

Key facts

Study ID

NCT02473965

Run by

Grifols Therapeutics LLC

People needed

60

Starts

2015-06-01

Expected to finish

2019-02-01

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Anti-acetylcholine receptor antibody positive
• Confirmed diagnosis of generalized MG historically meeting the clinical criteria for diagnosis of MG defined by the Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, IV, or V historically
• At Screening, subjects may have symptoms controlled by CS or were MGFA Class II-IVa inclusive (Class IVb and Class V excluded). Subjects who only have a history of ocular MG may not enroll.
• On systemic CS for a minimum period of at least 3 months and on a stable CS dose of >=15 mg/day and <=60 mg/day (prednisone equivalent) for the month prior to Screening.
• Had a tapering CS dose that the study investigator considered to be appropriate.
• At least 1 previous completed attempt to taper CS in order to minimize CS dose (lowest feasible dose based on observed MG signs and symptoms)

You may not qualify if…

• Any dose change in concomitant immunosuppressant therapy, other than CS, in the prior 6 months
• Any change in CS dose or acetylcholinesterase inhibitor (e.g., pyridostigmine) dose in the 1 month prior to Screening
• A 3-point change in Quantitative Myasthenia Gravis score, increased or decreased, between the Screening/Week -3 (Visit 0) and Baseline (Week 0 [Visit 1])
• Any episode of myasthenic crisis (MC) in the 1 month prior to Screening, or (at any time in the past) MC or hospitalization for MG exacerbation associated with a previous CS taper attempt
• Evidence of malignancy within the past 5 years (non-melanoma skin cancer, carcinoma in situ of cervix is allowed) or thymoma potentially requiring surgical intervention during the course of the trial (intent to perform thymectomy)
• Thymectomy within the preceding 6 months prior to Screening
• Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months prior to Screening
• Have received immune globulin treatment given by IV, subcutaneous, or intramuscular route within the last 3 months prior to Screening
• Received plasma exchange performed within the last 3 months prior to Screening
• History of anaphylactic reactions or severe reactions to any blood-derived product
• History of recent (within the last year) myocardial infarction or stroke
• Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram changes indicative of myocardial ischemia or atrial fibrillation
• Current known hyperviscosity or hypercoagulable state
• Currently receiving anti-coagulation therapy. Oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlopidine)
• Females of child-bearing potential who are pregnant, have a positive serum pregnancy test, breastfeeding, or are unwilling to practice a highly effective method of contraception throughout the study.
• Renal impairment
• Aspartate aminotransferase or alanine aminotransferase levels exceeding more than 2.5 times the upper limit of normal for the expected normal range for the testing laboratory.
• Hemoglobin (Hb) levels <9 g/dL

Where it is running

• University of California-Irvine — Orange, California, United States
• Yale University School of Medicine, Department of Neurology — New Haven, Connecticut, United States
• University of Florida at Shands Jacksonville — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University Wexner Medical Center, Neurology Department — Columbus, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• University of Washington Medical Center — Seattle, Washington, United States
• UZ Leuven — Leuven, Belgium
• London Health Sciences Centre- University Hospital — London, Ontario, Canada
• University Health Network (UHN) - Toronto General Hospital — Toronto, Ontario, Canada
• Fakultni nemocnice Brno, Dept of Neurologicka klinika — Brno, Czechia
• Fakultni nemocnice Ostrava — Ostrava - Poruba, Czechia
• Vseobecna fakultni nemocnice v Praze, Dept of Neurologicka klinika — Prague, Czechia
• East Tallinn Central Hospital — Tallinn, Estonia
• CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique — Strasbourg, Bas Rhin, France
• CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale — Toulouse, Haute Garonne, France
• Universitaetsklinikum Regensburg, Parent — Regensburg, Bavaria, Germany
• Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg — Marburg, Hesse, Germany

Full record on ClinicalTrials.gov

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