Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...