Clinical trial · Interventional
A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)
A Pilot Trial To Assess The Feasibility And Efficacy Of Subcutaneous Immunoglobulin In Patients With Myasthenia Gravis Exacerbation
- 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)
This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial. The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG in patients with worsening MG. Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are considered to be appropriate for immunoglobulin therapy will be screened for the study by the treating neurologist. Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused over 4 weeks in a dose escalating manner. Additionally, this study will be assessing the feasibility of employing SCIG as an alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a health-resource perspective and from a patient perspective.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human normal immunoglobulin G (IgG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SC Treatment Period
- description
- Participants will receive 2gm/kg of Human normal immunoglobulin G (IgG) infused over 4 weeks in a dose escalating manner as follows: * 1st week: 2-3 SCIG infusions of 10ml per site at four sites (total dose 16 to 24g)\* * 2nd week: 2-3 SCIG infusions of 15ml per site at four sites (total dose 24 to 36g)\* * 3rd week: 2-4 SCIG infusions of 20ml per site at four sites (total dose 32 to 64g)\* * 4th week: 2-4 SCIG infusions of 25ml per site at four sites (total dose 40 to 80g)\* * Doses indicated are study recommended. Doses may be adjusted depending on tolerance and total dose required by the patient.
- interventionNames
- Drug: Human normal immunoglobulin G (IgG)
Primary outcomes (1)
- measure
- Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 42 after treatment.
- timeFrame
- Baseline - Day 42
- description
- QMGS is a validated clinical measure of myasthenia gravis ranging from 0 points (no myasthenic weakness) to a maximum of 39 points, with a defined change of 3.4 units required for clinical significance.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between18 to 80 years of age, diagnosed with MG (see below) who have worsening myasthenic symptoms - (defined as increasing diplopia, ptosis, dysarthria, dysphagia, difficulty chewing, or limb weakness severe enough to warrant immunoglobulin therapy. * MG diagnosis will be based upon the clinical evaluation by a neuromuscular expert and meeting any two of the following supportive criteria: 1. Abnormal Tensilon test 2. Abnormal repetitive nerve stimulation studies 3. Abnormal single fiber electromyography (EMG) 4. Increased serum acetylcholine receptor or anti-MuSK antibodies 5. Prior response to immunotherapy Exclusion Criteria: 1. Respiratory distress requiring ICU admission or a vital capacity \<1 L 2. Severe swallowing difficulties with a high risk of aspiration 3. Change in corticosteroid dosage in the 4 weeks prior to screening 4. Known immunoglobulin A (IgA) deficiency 5. Pregnant or breast feeding women 6. Active renal or hepatic insufficiency, clinically significant cardiac disease 7. Patients with worsening weakness associated with an infectious process 8. Previous lack of responsiveness to IVIG 9. History of previous MG crises
References
Publications (0)
Data not yet available