Generalized Myasthenia Gravis
Conditions
Keywords
monoclonal antibody, batoclimab, IMVT-1401, Myasthenia Gravis, acetylcholine receptor, RVT-1401
Brief summary
The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.
Interventions
DRUGBatoclimab 680 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
DRUGMatching Placebo SC
Placebo
DRUGBatoclimab 340 mg SC bi-weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Sponsor Staff is also masked, so the study is Quadruple-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are ≥ 18 years of age at the Screening Visit. 2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit. 3. Have a QMG score ≥ 11 at the Screening and Baseline Visits. 4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits. 5. Additional inclusion criteria are defined in the protocol.
Exclusion criteria
1. Have experienced myasthenic crisis within 3 months of the Screening Visit. 2. Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study period. 3. Have any active or untreated malignant thymoma. 4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year. 5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment. 6. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants | Baseline (Day 1) to Week 12 | MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants | Baseline (Day 1) to Week 12 | QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment. |
| Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants | Baseline (Week 12) to Week 24 | — |
| Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score | Up to Week 12 | — |
| Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 | Up to Week 12 | — |
| Change from Baseline in MG-ADL score in AChRAb- (AChRAb negative) participants | Baseline (Day 1) to Week 12 | — |
Countries
Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Serbia, South Korea, Spain, United Kingdom, United States
Outcome results
None listed