A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Immunovant Sciences GmbH
- Study ID
- NCT07018323
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Graves' Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
Study Details
This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
Key Dates
- Start date
- Jun 19, 2025
- Status verified
- Jun 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: IMVT-1402 Dose 1
- Experimental: IMVT-1402 Dose 2
- Placebo Comparator: Placebo
Primary Outcome Measure
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) [ Time Frame: Week 26 ]
Central Contacts
- Central Study Contact18007970414
Locations (33)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site Number - 1015 | Tucson | Arizona | 85710 | - |
| Site Number -1014 | Concord | California | 94520 | - |
| Site Number - 1013 | Aurora | Colorado | 80045 | - |
| Site Number - 1024 | Doral | Florida | 33166 | - |
| Site Number - 1008 | Hialeah | Florida | 33016 | - |
| Site Number - 1000 | Miami | Florida | 33143 | - |
| Site Number - 1020 | Columbus | Georgia | 31904 | - |
| Site Number - 1022 | Topeka | Kansas | 66606 | - |
| Site Number - 1030 | Louisville | Kentucky | 40202 | - |
| Site Number - 1033 | Jefferson City | Missouri | 65109 | - |
| Site Number - 1004 | Kansas City | Missouri | 64110 | - |
| Site Number - 1019 | St Louis | Missouri | 63110 | - |
| Site Number - 1012 | Reno | Nevada | 89511 | - |
| Site Number - 1032 | Long Island City | New York | 11106 | - |
| Site Number - 1027 | New Hyde Park | New York | 11434 | - |
| Site Number - 1009 | New York | New York | 10022 | - |
| Site Number - 1018 | Williamsville | New York | 14221 | - |
| Site Number - 1010 | Chapel Hill | North Carolina | 27514 | - |
| Site Number - 1026 | Hickory | North Carolina | 28601 | - |
| Site Number - 1001 | Morehead City | North Carolina | 27577 | - |
| Site Number - 1034 | Raleigh | North Carolina | 27612 | - |
| Site Number - 1007 | Oklahoma City | Oklahoma | 73134 | - |
| Site Number - 1017 | Memphis | Tennessee | 38119 | - |
| Site Number - 1029 | Dallas | Texas | 75224 | - |
| Site Number - 1002 | El Paso | Texas | 79935 | - |
| Site Number - 1003 | Fort Worth | Texas | 76132 | - |
| Site Number - 1028 | Houston | Texas | 77054 | - |
| Site Number - 1031 | Houston | Texas | 77030 | - |
| Site Number - 1021 | Irving | Texas | 75039 | - |
| Site Number -1023 | Irving | Texas | 75031 | - |
| Site Number - 1025 | McKinney | Texas | 75069 | - |
| Site Number - 1011 | San Antonio | Texas | 78231 | - |
| Site Number - 1016 | Norfolk | Virginia | 23510 | - |
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