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IMVT-1402 · 7 trials · 6 indications
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.
| Arm | Type | Description |
|---|---|---|
| Group 1: IMVT-1402 Dose 1 | EXPERIMENTAL | - |
| Group 2: IMVT-1402 Dose 2 | EXPERIMENTAL | - |
| Placebo/ IMVT-1402 | PLACEBO_COMPARATOR | - |
| Group A | EXPERIMENTAL | - |
| Group B | NO_INTERVENTION | - |
| Group C | NO_INTERVENTION | - |
| Placebo | PLACEBO_COMPARATOR | - |
| IMVT-1402 Dose 1 | EXPERIMENTAL | - |
| IMVT-1402 Dose 2 | EXPERIMENTAL | - |
| Period 1: Placebo | PLACEBO_COMPARATOR | Matching placebo for 12 weeks in Period 1 |
| IMVT-1402 Subcutaneous (SC) Once weekly (QW) | EXPERIMENTAL | * Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks * Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks * Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks |
| Group 1 Period 1 and 2: IMVT-1402 | EXPERIMENTAL | - |
| Group 2 Period 1 and 2: IMVT-1402 | EXPERIMENTAL | - |
| Group 2 Period 1: IMVT-1402 and Period 2: Placebo | EXPERIMENTAL | - |
| Group 3 Period 1 and 2: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IMVT-1402 | DRUG | • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1) |
| Placebo | DRUG | • Placebo SC QW for 12 weeks (Period 1) |
Inclusion Criteria: * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at th...
IMVT-1402 is an investigational small molecule drug being developed by Immunovant, Inc. (ticker IMVT). It is in Phase 3 clinical development for generalized myasthenia gravis and is also being studied in Graves' disease, cutaneous lupus erythematosus, and other autoimmune indications. It has not been approved by the FDA and remains under clinical investigation.
IMVT-1402 targets the neonatal Fc receptor, commonly known as FcRn. By binding to FcRn, the drug is designed to reduce recycling of immunoglobulin G antibodies, lowering circulating IgG levels. This mechanism is being explored across several autoimmune conditions in which pathogenic IgG antibodies are thought to play a role.
IMVT-1402 is being developed by Immunovant, Inc., which trades on the Nasdaq under the ticker IMVT. Immunovant is the sponsor of the clinical trials evaluating the drug across generalized myasthenia gravis, Graves' disease, and cutaneous lupus erythematosus.
IMVT-1402 is in Phase 3 development. The Phase 3 trial is in generalized myasthenia gravis, while studies in Graves' disease and cutaneous lupus erythematosus are Phase 2. The drug is investigational and has not received FDA approval. Three trials are currently active, with no completed trials reported.
IMVT-1402 is being evaluated in several trials. NCT07039916 is a Phase 3 study in generalized myasthenia gravis. NCT07018323 is a Phase 2 study in Graves' disease, and NCT07286006 is a Phase 2 long-term extension study in Graves' disease. NCT06980805 is a Phase 2 study in cutaneous lupus erythematosus.
IMVT-1402 is being studied as a treatment for adults with mild to severe generalized myasthenia gravis. The Phase 3 trial NCT07039916 is recruiting participants aged 18 and older across the United States, Europe, and other regions. The drug is investigational and has not been approved for this or any other indication.