Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis
NCT02473952CI-TRIAL-00037453completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IGIV-C | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IGIV-C
- description
- IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified. An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).
- interventionNames
- Drug: IGIV-C
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).
- interventionNames
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria:
* Anti-acetylcholine receptor (AChR) antibody positive
* Confirmed diagnosis of generalized myasthenia gravis (MG).
* Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa inclusive at Screening.
* QMG \>= 10 at Screening. Note: Subjects who only have a history of ocular MG may not enroll.
* Receiving standard of care MG treatment at a stable dose consisting of any one of the following for the time intervals delineated below (time intervals apply to medications and maintenance of stable dose level):
1. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening and no immunosuppressants
2. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR only one of the following:
1. Prednisone (up to 60 mg/day or equivalent) for at least 2 months prior to Screening, OR
2. Azathioprine for at least 6 months prior to Screening, OR
3. Mycophenolate mofetil for at least 6 months prior to Screening, OR
4. Methotrexate for at least 6 months prior to Screening, OR
5. Cyclosporine or tacrolimus for at least 3 months prior to Screening
3. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR prednisone (up to 60 mg/day or equivalent) for at least one month prior to Screening and only one of the following:
1. Azathioprine for at least 6 months prior to Screening, OR
2. Mycophenolate mofetil for at least 6 months prior to Screening, OR
3. Methotrexate for at least 6 months prior to Screening, OR
4. Cyclosporine or tacrolimus for at least 3 months prior to Screening
Exclusion Criteria:
* Have received cyclophosphamide or any other immunosuppressive agent apart from the ones allowed per inclusion criteria within the past 6 months
* Any change in MG treatment regimen between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
* Greater than two point change in QMG score, increased or decreased, between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
* Any episode of myasthenic crisis in the one month prior to Screening
* 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
* Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months
* Have received immune globulin (Ig) treatment given by intravenous (IV), subcutaneous, or intramuscular route within the last 3 months
* Current known hyperviscosity or hypercoagulable state
* Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants \[e.g., dabigatran etexilate, rivaroxaban, edoxaban, and apixaban\], parenteral anticoagulants \[e.g., fondaparinux\]). Note that oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)
* Documented diagnosis of thrombotic complications to polyclonal intravenous immunoglobulin (IVIg) therapy in the past
* History of recent (within the last year) myocardial infarction or stroke
* Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
* History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
* Plasma exchange (PLEX) performed within the last 3 months
* Renal impairment (i.e., serum creatinine exceeds more than 1.5 times the upper limit of normal \[ULN\] for the expected normal range for the testing laboratory).
* Hemoglobin levels less than 9 g per dLReferences
Publications (1)
- DERIVEDDalakas MC, Meisel A. Immunomodulatory effects and clinical benefits of intravenous immunoglobulin in myasthenia gravis. Expert Rev Neurother. 2022 Apr;22(4):313-318. doi: 10.1080/14737175.2022.2057223. Epub 2022 Apr 5. PMID 35350948