Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Immunovant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 209 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
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, etc.) 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 exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to Placebo as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.;Secondary Objective: To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to Placebo as Induction Therapy in AChRAb+ participants as assessed by change in Quantitative Myasthenia Gravis (QMG) score. To evaluate the efficacy of batoclimab 340 mg SC QW or 340 mg SC once every 2 weeks (Q2W) compared to Placebo as Maintenance Therapy in AChRAb+ participants who responded to Induction Therapy with batoclimab as assessed by changes in the MG-ADL score. To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to Placebo as Induction Therapy in AChRAb+ participants for achieving improvement (decrease in score) in QMG score. Please refer to protocol section 2.4 for more secondary objectives.;Primary end point(s): Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12) ;Timepoint(s) of evaluation of this end point: per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Period 1 baseline in QMG score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12) Change from Period 2 baseline in MG-ADL score to Week 24 for AChRAb+ randomized withdrawal participants (Timeframe: Week 12 to Week 24) Proportion of AChRAb+ participants with = 3-point improvement (decrease in score) in QMG from Period 1 baseline to Week 12 (Timeframe: Period 1 baseline to Week 12) Proportion of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 (Timeframe: Period 1 baseline to Week 12) Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb- participants (Timeframe: Period 1 baseline to Week 12);Timepoint(s) of evaluation of this end point: per protocol | — |
Countries
Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Romania, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactRichard Valanzola
Immunovant Sciences GmbH
Outcome results
None listed