Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RVT-1401 · 2 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Vital signs including SBP, DBP, pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Serum samples were collected for the analysis of total immunoglobulin G. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Serum samples were collected for the analysis of IgG 1, 2, 3 and 4 levels. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Serum samples were collected for the analysis of Anti-AChR-IgG. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
AEs were defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as AEs that either started on or after the date of the first dose of study drug and on or before the date of the last dose of study drug + 42 days, or had no recorded start date and the stop date was in between the date of the first dose and the last dose of study drug + 42 days. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Clinical significance was determined by the investigator.
Abnormality was determined by the investigator.
Clinical significance was determined by the investigator.
The serum levels of total IgG and IgG subclasses (1-4) were determined. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7, Week 6 and 7 combined) minus the Baseline value, divided by the Baseline value x 100. A negative percent change from Baseline represents clinical improvement.
The serum levels of anti-TSHR antibodies were determined. Change from Baseline was calculated as the Week 7 value minus the Baseline value. A negative change from Baseline represents clinical improvement.
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Regimen B | EXPERIMENTAL | RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Placebo | PLACEBO_COMPARATOR | Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| RVT-1401 | EXPERIMENTAL | RVT-1401 680 milligrams (mg) weekly for two weeks followed by 340 mg weekly for four weeks, administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| RVT-1401 | DRUG | Subcutaneous administration of RVT-1401 |
| Placebo | DRUG | Subcutaneous administration of Placebo |
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of a respirator for the duration of the study as judged by the Investigator. 3. QMG score ≥12 at Screening and Baseline. Other, more specific inclusion cri...
RVT-1401 is an investigational monoclonal antibody being studied for Graves' Ophthalmopathy and Myasthenia Gravis. It has been evaluated in Phase 2 clinical trials for both conditions. It is not approved for any indication and remains in clinical development.
RVT-1401 is being developed by Immunovant, Inc., which trades under the ticker IMVT. The company is the sponsor of the clinical program evaluating the drug in Graves' Ophthalmopathy and Myasthenia Gravis.
RVT-1401 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in Graves' Ophthalmopathy and one in Myasthenia Gravis. The drug is investigational and has not been approved by the FDA for any indication.
RVT-1401 has been studied in two completed Phase 2 trials. NCT03922321 evaluated RVT-1401 in patients with moderate to severe active Graves' Ophthalmopathy in Canada. NCT03863080 evaluated RVT-1401 in Myasthenia Gravis patients in the United States and Canada.
The RVT-1401 clinical program enrolled a total of 24 patients across two completed Phase 2 trials. NCT03922321 enrolled 7 patients with Graves' Ophthalmopathy, and NCT03863080 enrolled 17 patients with Myasthenia Gravis.