Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
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| ClinicalTrials.gov Identifier: NCT05403541 |
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Recruitment Status :
Recruiting
First Posted : June 3, 2022
Last Update Posted : January 5, 2024
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Sponsor:
Immunovant Sciences GmbH
Information provided by (Responsible Party):
Immunovant Sciences GmbH
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Generalized Myasthenia Gravis | Drug: Batoclimab 680 mg SC weekly Drug: Batoclimab 340 mg SC weekly Drug: Matching Placebo SC Drug: Batoclimab 340 mg SC bi-weekly | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Sponsor Staff is also masked, so the study is Quadruple-blind. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG) |
| Actual Study Start Date : | June 27, 2022 |
| Estimated Primary Completion Date : | April 2024 |
| Estimated Study Completion Date : | April 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Myasthenia gravis
MedlinePlus related topics:
Myasthenia Gravis
| Arm | Intervention/treatment |
|---|---|
| Experimental: Batoclimab Induction Dose 1 (Period 1) |
Drug: Batoclimab 680 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Name: IMVT-1401 |
| Experimental: Batoclimab Induction Dose 2 (Period 1) |
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Name: IMVT-1401 |
| Placebo Comparator: Placebo Induction Dose (Period 1) |
Drug: Matching Placebo SC
Placebo |
| Experimental: Batoclimab Maintenance Dose 1 (Period 2) |
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Name: IMVT-1401 |
| Experimental: Batoclimab Maintenance Dose 2 (Period 2) |
Drug: Batoclimab 340 mg SC bi-weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Name: IMVT-1401 |
| Placebo Comparator: Placebo Maintenance Dose (Period 2) |
Drug: Matching Placebo SC
Placebo |
Primary Outcome Measures :
- Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants [ Time Frame: 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 Outcome Measures :
- Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants [ Time Frame: 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 [ Time Frame: Baseline (Week 12) to Week 24 ]
- Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score [ Time Frame: Up to Week 12 ]
- Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 [ Time Frame: Up to Week 12 ]
- Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants [ Time Frame: Baseline (Day 1) to Week 12 ]
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 76 Weeks ]An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.
- Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements [ Time Frame: Up to 76 Weeks ]Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.
- Number of Participants with Clinically Significant Changes in Laboratory Results [ Time Frame: Up to 76 Weeks ]Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.
- Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities. [ Time Frame: Up to 76 Weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are ≥ 18 years of age at the Screening Visit.
- Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
- Have a QMG score ≥ 11 at the Screening and Baseline Visits.
- Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
- Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
- Have experienced myasthenic crisis within 3 months of the Screening Visit.
- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
- Have any active or untreated malignant thymoma.
- 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.
- 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.
- Additional exclusion criteria are defined in the protocol.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05403541
Contacts
| Contact: Central Study Contact | 18007970414 | clinicaltrials@immunovant.com |
Locations
Show 78 study locations
Sponsors and Collaborators
Immunovant Sciences GmbH
| Responsible Party: | Immunovant Sciences GmbH |
| ClinicalTrials.gov Identifier: | NCT05403541 |
| Other Study ID Numbers: |
IMVT-1401-3101 |
| First Posted: | June 3, 2022 Key Record Dates |
| Last Update Posted: | January 5, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Immunovant Sciences GmbH:
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monoclonal antibody batoclimab IMVT-1401 |
Myasthenia Gravis acetylcholine receptor RVT-1401 |
Additional relevant MeSH terms:
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Myasthenia Gravis Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms |
Neoplasms by Site Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases |