Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515979-35-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: IMVT-1402 Dose 1 | Experimental |
| |
| Group 2: IMVT-1402 Dose 2 | Experimental |
| |
| Placebo/ IMVT-1402 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in MG-ADL Score for Antibody-positive Participants | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants | Baseline to Week 12 | |
| Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1 | Week 12 |
Not provided
Inclusion Criteria:
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
Additional exclusion criteria are defined in the protocol.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Study Contact | Contact | 18007970414 | clinicaltrials@immunovant.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1056 | Recruiting | Huntsville | Alabama | 35801 | United States | |
| Site Number - 1041 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Sponsor will also be blinded.
| IMVT-1402 | Drug |
|
|
| Placebo | Drug | • Placebo SC QW for 12 weeks (Period 1) |
|
| IMVT-1402 | Drug |
|
|
| Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score | Baseline to Week 12 |
| Recruiting |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Site Number - 1017 | Recruiting | Phoenix | Arizona | 85028 | United States |
| Site Number - 1025 | Recruiting | Scottsdale | Arizona | 85251 | United States |
| Site Number - 1042 | Recruiting | Tucson | Arizona | 85718 | United States |
| Site Number - 1010 | Recruiting | Carlsbad | California | 92011 | United States |
| Site Number - 1028 | Recruiting | Irvine | California | 92697 | United States |
| Site Number - 1023 | Recruiting | Los Angeles | California | 90033 | United States |
| Site Number - 1029 | Recruiting | Rancho Mirage | California | 92270 | United States |
| Site Number - 1004 | Recruiting | San Francisco | California | 94143 | United States |
| Site Number - 1027 | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Site Number - 1001 | Recruiting | New Haven | Connecticut | 06510 | United States |
| Site Number - 1024 | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Site Number - 1006 | Recruiting | Clearwater | Florida | 33761 | United States |
| Site Number - 1037 | Recruiting | Ormond Beach | Florida | 32174 | United States |
| Site Number - 1002 | Recruiting | Port Charlotte | Florida | 33952 | United States |
| Site Number - 1050 | Recruiting | Rockledge | Florida | 32955 | United States |
| Site Number - 1007 | Recruiting | Tampa | Florida | 33612 | United States |
| Site Number - 1014 | Recruiting | Atlanta | Georgia | 30329 | United States |
| Site Number - 1043 | Recruiting | Augusta | Georgia | 30912 | United States |
| Site Number - 1054 | Recruiting | Schaumburg | Illinois | 60173 | United States |
| Site Number - 1022 | Recruiting | Lexington | Kentucky | 40536-0284 | United States |
| Site Number - 1032 | Recruiting | Nicholasville | Kentucky | 40356 | United States |
| Site Number - 1046 | Recruiting | New Orleans | Louisiana | 70121 | United States |
| Site Number - 1049 | Recruiting | Foxborough | Massachusetts | 02035 | United States |
| Site Number - 1026 | Recruiting | Detroit | Michigan | 48201 | United States |
| Site Number - 1005 | Recruiting | East Lansing | Michigan | 48824 | United States |
| Site Number - 1018 | Recruiting | Omaha | Nebraska | 68198 | United States |
| Site Number - 1019 | Recruiting | Totowa | New Jersey | 07512 | United States |
| Site Number - 1036 | Recruiting | New York | New York | 10021 | United States |
| Site Number - 1034 | Recruiting | New York | New York | 10065 | United States |
| Site Number - 1020 | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| Site Number - 1013 | Recruiting | Durham | North Carolina | 27710 | United States |
| Site Number - 1044 | Recruiting | Raleigh | North Carolina | 27607 | United States |
| Site Number - 1038 | Recruiting | Cincinnati | Ohio | 45221 | United States |
| Site Number - 1045 | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Site Number - 1011 | Recruiting | Yukon | Oklahoma | 73099 | United States |
| Site Number - 1031 | Recruiting | Eugene | Oregon | 97477 | United States |
| Site Number - 1030 | Recruiting | Charleston | South Carolina | 29425 | United States |
| Site Number - 1015 | Recruiting | Charleston | South Carolina | 29486 | United States |
| Site Number - 1021 | Recruiting | Memphis | Tennessee | 38120 | United States |
| Site Number - 1003 | Recruiting | Dallas | Texas | 75206 | United States |
| Site Number - 1047 | Recruiting | Denton | Texas | 76208 | United States |
| Site Number - 1048 | Recruiting | Lubbock | Texas | 79414 | United States |
| Site Number - 1009 | Recruiting | Charlottesville | Virginia | 22903 | United States |
| Site Number - 1040 | Recruiting | Richmond | Virginia | 23298 | United States |
| Site Number - 1035 | Recruiting | Greenfield | Wisconsin | 53228 | United States |
| Site Number - 5002 | Recruiting | Rosario | S2000 | Argentina |
| Site Number - 3201 | Recruiting | Brno | 60300 | Czechia |
| Site Number - 3601 | Recruiting | Copenhagen | 2177 | Denmark |
| Site Number - 8002 | Recruiting | Tbilisi | 0114 | Georgia |
| Site Number - 8003 | Recruiting | Tbilisi | 114 | Georgia |
| Site Number - 8001 | Recruiting | Tbilisi | 159 | Georgia |
| Site Number - 6502 | Recruiting | Bochum | 44791 | Germany |
| Site Number - 6504 | Recruiting | Goettigen | 37075 | Germany |
| Site Number - 6505 | Recruiting | Magdeburg | 39120 | Germany |
| Site Number - 6503 | Recruiting | Würzburg | 97070 | Germany |
| Site Number - 3903 | Recruiting | Athens | 11528 | Greece |
| Site Number - 3902 | Recruiting | Athens | 12462 | Greece |
| Site Number - 3901 | Recruiting | Pátrai | 26504 | Greece |
| Site Number - 3904 | Recruiting | Thessaloniki | 54642 | Greece |
| Site Number - 7552 | Recruiting | Budapest | 1085 | Hungary |
| Site Number - 7553 | Recruiting | Budapest | 1204 | Hungary |
| Site Number - 7551 | Recruiting | Kistarcsa | 2143 | Hungary |
| Site Number - 6003 | Recruiting | Bergamo | 24127 | Italy |
| Site Number - 6002 | Recruiting | Milan | 20133 | Italy |
| Site Number - 6001 | Recruiting | Naples | 80131 | Italy |
| Site Number - 6004 | Recruiting | Rome | 136 | Italy |
| Site Number - 3005 | Recruiting | Gdansk | 80-214 | Poland |
| Site Number - 3001 | Recruiting | Katowice | 40-689 | Poland |
| Site Number - 3006 | Recruiting | Krakow | 31-324 | Poland |
| Site Number - 3002 | Recruiting | Krakow | 31-503 | Poland |
| Site Number - 3003 | Recruiting | Krakow | 31-505 | Poland |
| Site Number - 3004 | Recruiting | Lublin | 20-701 | Poland |
| Site Number - 3007 | Recruiting | Warsaw | 01-684 | Poland |
| Site Number - 7502 | Recruiting | Constanța | 900348 | Romania |
| Site Number - 7501 | Recruiting | Târgu Mureş | 540136 | Romania |
| Site Number - 9001 | Recruiting | Belgrade | 11000 | Serbia |
| Site Number - 9002 | Recruiting | Niš | 18000 | Serbia |
| Site Number - 7103 | Recruiting | Barcelona | 8195 | Spain |
| Site Number - 7101 | Recruiting | Córdoba | 14011 | Spain |
| Site Number - 7104 | Recruiting | Madrid | 28034 | Spain |
| Site Number - 7002 | Recruiting | Glasgow | G51 4TF | United Kingdom |
| Site Number - 7004 | Recruiting | London | WC1N 3BG | United Kingdom |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided