Myasthenia GravisPhase 2MG_SCIGNCT04728425
Subcutaneous Immunoglobulin for Myasthenia Gravis
A Phase 2 study testing subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG) in people with Myasthenia Gravis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a prospective open-label, randomized, parallel arm clinical trial. The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2020to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over age 18
- Patients with a confirmed diagnosis of myasthenia gravis based on clinical criteria including fatiguable weakness and supported by either serological (acetylcholine receptor, muscle specific kinase or anti-low-density lipoprotein receptor- related protein 4 antibodies or electrophysiological testing (repetitive nerve stimulation of single fiber electromyography)
- Myasthenia Gravis Federation of America class II-IV
- Moderate to severe myasthenia gravis as defined by a quantitative myasthenia gravis score >10 or generalized myasthenia gravis impairment index score > 11
- Patient able to give consent and is able and willing to complete all study procedures and activities
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients not able to complete the study procedures or with an alternate diagnosis
- Patients with recent thymectomy in the past 6 months
- Patients receiving another biologic agent such as rituximab, belimubab, cyclophosphamide and eculizumab in the past 6 months prior to study entry
- No IVIG or subcutaneous immunoglobulin within the past month
- Patients on prednisone who have had alterations in prednisone dose over the past month prior to study entry
- Patients will previous known allergy or severe adverse reaction to intravenous or subcutaneous immunoglobulin
- Evidence of renal insufficiency (Cr>1.5 x elevated) or liver disease (transaminases > 2.5 x elevation) at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Subcutaneous Immunoglobulin in Patients With Myasthenia Gravis
This is a prospective open-label, randomized, parallel arm clinical trial.
The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective is to evaluate patient preferences and effects on quality of life when treating MG patients with SCIG. Exploratory objectives are to compare de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration.
Read more
Patients over age 18 with moderate to severe MG with MGFA Class II-IV without contraindications to immunoglobulin will be considered for the study.
All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.
Read the detailed description
Myasthenia gravis (MG) is an autoimmune neuromuscular condition which can cause fatigable weakness of skeletal muscles including bulbar, ocular, limb, axial and respiratory muscles. Symptoms range from mild, transient double vision and ptosis to severe, life threatening diffuse weakness, and treatments which are immunosuppressive or immunomodulatory have been shown to improve outcome in MG. This includes 10% intravenous immunoglobulin (IVIG), which has previous been shown by our group to improve strength at 2 and 4 weeks in patients with MG. Due to delay in the onset of many immunosuppressives and potential side effects from steroids and other immunosuppressive medications, IVIG is also used in clinical practice as bridging of maintenance therapy until other therapies take effect or the patient stabilizes. In addition, there have been other studies suggesting that 20% subcutaneous immunoglobuin (SCIG) can be helpful to improve strength in patients with MG over a relatively short period of time (6 weeks). Some of these studies are ongoing and are further evaluating the ability of IVIG and SCIG to stabilize or improve strength IVIG in patients with MG, however, there is no current published study evaluating different administration routes of immunoglobulin (IVIG and SCIG) in patients with MG over a longer 6 month follow-up period.
The current study aims to be the first to evaluate 20% Cuvitru SCIG formulation in patients with neuromuscular conditions including MG. The study aim is to evaluate the safety and efficacy of 6 months of 20% SCIG Cuvitru treatment vs three months of 10% IVIG "pre-treatment" followed by 3 months of 20% SCIG Cuvitru treatment. The study will also be the first to use the myasthenia gravis impairment index (MGII) as primary outcome in conjunction with standard MG outcomes.
- Conditions
- Myasthenia Gravis
- Being tested
- subcutaneous immunoglobulin (SCIG), intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)
- Keywords
- myasthenia gravis, IVIG, SCIG, subcutaneous immunoglobulin, intravenous immunoglobulin, MG, neuromuscular junction
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous immunoglobulin (SCIG)Drug
Also called Cuvitru
20% subcutaneous immunoglobulin
intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)Drug
Also called Gammanorm + Cuvitru
10% intravenous immunoglobulin + 20% subcutaneous immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| IVIG + SCIG | Active comparator | This group of MG patients will start with 2g/kg of IVIG on month 1, 1 g/kg of IVIG 4 and then 8 weeks later, and within 2 weeks switch to SCIG treatment Receives: Drug: intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG) |
| SCIG alone | Active comparator | This group of MG patients will start with SCIG alone Receives: Drug: subcutaneous immunoglobulin (SCIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myasthenia Gravis Impairment Index Efficacy Outcome
Change in the Myasthenia Gravis Impairment Index (score 0-84, with 84 being the maximal score indicating the most severe MG status) at baseline compared to end of study
Measured: 6 months
Secondary outcomes (6)
Quantitative Myasthenia Gravis Score Efficacy Outcome
Change in the Quantitative Myasthenia Gravis Score (score 0-39, with 39 indicating the most severe clinical findings related to MG) at baseline compared to end of study
Measured: 6 months
Myasthenia Gravis Activities of Daily Living Efficacy Outcome
Change in the MG Activities of Daily Living (score 0-24, with 24 indicating the most severe clinical findings related to MG) at baseline compared to end of study
Measured: 6 months
Myasthenia Gravis Composite Efficacy Outcome
Change in the Myasthenia Gravis Composite Score (score 0-50, with 50 indicating the most severe clinical findings related to MG) at baseline compared to end of study) at baseline compared to end of study
Measured: 6 months
Myasthenia gravis Quality of Life 15 Score Efficacy Outcome
Change in the 15-Item Myasthenia Gravis Quality of Life Score (score 0-45, with 45 indicating the most severe clinical findings related to MG) at baseline compared to end of study) at baseline compared to end of study
Measured: 6 months
Parallel Arm Comparison
All the above outcomes including the myasthenia gravis impairment index, quantitative myasthenia gravis score, myasthenia gravis activities of daily living, myasthenia gravis composite score, myasthenia gravis quality of life 15 score in patients receiving de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration will be compared.
Measured: 6 months
Safety and Tolerability: total number of adverse events
- evaluate the adverse event profile of high dose (20% Cuvitru) SCIG in MG and compare this with existing published adverse events of 20% high-dose SCIG in neuromuscular diseases. Specifically the total number of adverse events as defined in Part C, Division 5 of the Health Canada Food and Drug Regulations will be compared to existing published adverse events of 20% SCIG and the total number of adverse events occuring in the IVIG vs SCIG arms will also be compared.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start28 Aug 2020
- Primary completion30 Jun 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Katzberg, University Health Network, Toronto
- Investigators
- Hans Katzberg, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728425
- Sponsor's protocol ID
- 19-5378.2
- Acronym
- MG_SCIG
- Status last verified
- Apr 2025
- First submitted
- 14 Jul 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Subcutaneous Immunoglobulin in Patients With Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT04728425
- Acronym / sponsor ID
- MG_SCIG / 19-5378.2
- Conditions
- Myasthenia Gravis
- Keywords
- myasthenia gravis, IVIG, SCIG, subcutaneous immunoglobulin, intravenous immunoglobulin, MG, neuromuscular junction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective open-label, randomized, parallel arm clinical trial.
The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective is to evaluate patient preferences and effects on quality of life when treating MG patients with SCIG. Exploratory objectives are to compare de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration.
Patients over age 18 with moderate to severe MG with MGFA Class II-IV without contraindications to immunoglobulin will be considered for the study.
All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.
Detailed description
Myasthenia gravis (MG) is an autoimmune neuromuscular condition which can cause fatigable weakness of skeletal muscles including bulbar, ocular, limb, axial and respiratory muscles. Symptoms range from mild, transient double vision and ptosis to severe, life threatening diffuse weakness, and treatments which are immunosuppressive or immunomodulatory have been shown to improve outcome in MG. This includes 10% intravenous immunoglobulin (IVIG), which has previous been shown by our group to improve strength at 2 and 4 weeks in patients with MG. Due to delay in the onset of many immunosuppressives and potential side effects from steroids and other immunosuppressive medications, IVIG is also used in clinical practice as bridging of maintenance therapy until other therapies take effect or the patient stabilizes. In addition, there have been other studies suggesting that 20% subcutaneous immunoglobuin (SCIG) can be helpful to improve strength in patients with MG over a relatively short period of time (6 weeks). Some of these studies are ongoing and are further evaluating the ability of IVIG and SCIG to stabilize or improve strength IVIG in patients with MG, however, there is no current published study evaluating different administration routes of immunoglobulin (IVIG and SCIG) in patients with MG over a longer 6 month follow-up period.
The current study aims to be the first to evaluate 20% Cuvitru SCIG formulation in patients with neuromuscular conditions including MG. The study aim is to evaluate the safety and efficacy of 6 months of 20% SCIG Cuvitru treatment vs three months of 10% IVIG "pre-treatment" followed by 3 months of 20% SCIG Cuvitru treatment. The study will also be the first to use the myasthenia gravis impairment index (MGII) as primary outcome in conjunction with standard MG outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG + SCIG | Active comparator | Drug: intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)This group of MG patients will start with 2g/kg of IVIG on month 1, 1 g/kg of IVIG 4 and then 8 weeks later, and within 2 weeks switch to SCIG treatment |
| SCIG alone | Active comparator | Drug: subcutaneous immunoglobulin (SCIG)This group of MG patients will start with SCIG alone |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over age 18
- Patients with a confirmed diagnosis of myasthenia gravis based on clinical criteria including fatiguable weakness and supported by either serological (acetylcholine receptor, muscle specific kinase or anti-low-density lipoprotein receptor- related protein 4 antibodies or electrophysiological testing (repetitive nerve stimulation of single fiber electromyography)
- Myasthenia Gravis Federation of America class II-IV
- Moderate to severe myasthenia gravis as defined by a quantitative myasthenia gravis score >10 or generalized myasthenia gravis impairment index score > 11
- Patient able to give consent and is able and willing to complete all study procedures and activities
Key exclusion criteria (8 listed)
- Patients who are pregnant or breastfeeding
- Patients not able to complete the study procedures or with an alternate diagnosis
- Patients with recent thymectomy in the past 6 months
- Patients receiving another biologic agent such as rituximab, belimubab, cyclophosphamide and eculizumab in the past 6 months prior to study entry
- No IVIG or subcutaneous immunoglobulin within the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous immunoglobulin (SCIG)Also: Cuvitru20% subcutaneous immunoglobulin | Drug | SCIG alone |
| intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)Also: Gammanorm + Cuvitru10% intravenous immunoglobulin + 20% subcutaneous immunoglobulin | Drug | IVIG + SCIG |
Primary outcome
Myasthenia Gravis Impairment Index Efficacy Outcome
Time frame: 6 months
Change in the Myasthenia Gravis Impairment Index (score 0-84, with 84 being the maximal score indicating the most severe MG status) at baseline compared to end of study
6 secondary outcomes
Quantitative Myasthenia Gravis Score Efficacy Outcome
Time frame: 6 months
Myasthenia Gravis Activities of Daily Living Efficacy Outcome
Time frame: 6 months
Myasthenia Gravis Composite Efficacy Outcome
Time frame: 6 months
Myasthenia gravis Quality of Life 15 Score Efficacy Outcome
Time frame: 6 months
Parallel Arm Comparison
Time frame: 6 months
Safety and Tolerability: total number of adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Katzberg, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG) in people with Myasthenia Gravis, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myasthenia Gravis Impairment Index Efficacy Outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.