Trial · NCT03863080

A Study of RVT-1401 in Myasthenia Gravis (MG) Patients

NCT03863080, Phase 2, Completed, Immunovant Sciences GmbH; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of RVT-1401 in Myasthenia Gravis (MG) Patients. Trials, record NCT03863080. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03863080

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
NCT number: NCT03863080
Status: Completed
Phases: Phase 2
Enrollment: 17 participants, actual
Lead sponsor: Immunovant Sciences GmbH
Conditions: Myasthenia Gravis
Interventions: RVT-1401, Placebo
First posted: 2019-03-05
Last updated: 2023-12-20
Results first posted: 2023-12-20

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Week 18	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.
Primary	Open-Label Extension Period: Number of Participants Reporting AEs and SAEs	Up to Week 18	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.
Primary	Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs	Up to Week 7	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.
Primary	Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs	Up to Week 18	Vital signs including SBP, DBP, pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
Primary	Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters	Up to Week 7	Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Primary	Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters	Up to Week 18	Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
Primary	Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	Up to Week 7	Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Primary	Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG	Up to Week 18	Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
Primary	Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG)	Baseline (Day 1) and Up to Week 7	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.
Primary	Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4	Baseline (Day 1) and Up to Week 7	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.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Week 18	Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-Label Extension Period: Number of Participants Reporting AEs and SAEs	Up to Week 18	Open-label Extension (OLE) Analysis Set comprised of all participants who enrolled in the OLE study phase and received at least 1 dose of study medication in the OLE. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs	Up to Week 7	Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs	Up to Week 18	OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters	Up to Week 7	Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters	Up to Week 18	OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	Up to Week 7	Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG	Up to Week 18	OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG)	Baseline (Day 1) and Up to Week 7	Full Analysis Set comprised of all randomized participants who received at least 1 dose of randomized study medication with at least 1 valid post-treatment value. Only those participants with data available at specified time points has been presented.	Percent change	LEAST_SQUARES_MEAN
PRIMARY	Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4	Baseline (Day 1) and Up to Week 7	Full Analysis Set. Only those participants with data available at specified time points has been presented.	Percent change	LEAST_SQUARES_MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group131

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: Placebo	Any AE	5	Participants
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: RVT-1401 340 mg/Week	Any AE	4	Participants
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: RVT-1401 680 mg/Week	Any AE	5	Participants
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: Placebo	Any SAE	0	Participants
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: RVT-1401 340 mg/Week	Any SAE	0	Participants
Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Double-blind Treatment Period: RVT-1401 680 mg/Week	Any SAE	1	Participants
Open-Label Extension Period: Number of Participants Reporting AEs and SAEs	Open-Label Extension Period: RVT-1401 340 mg Biweekly	Any AE	10	Participants
Open-Label Extension Period: Number of Participants Reporting AEs and SAEs	Open-Label Extension Period: RVT-1401 340 mg Biweekly	Any SAE	1	Participants
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs	Double-blind Treatment Period: Placebo		0	Participants
Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs	Double-blind Treatment Period: RVT-1401 340 mg/Week		0	Participants

1 to 10 of 131Source ClinicalTrials.gov

See all 131 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-Blind Treatment Period (6 Weeks)	STARTED	Double-blind Treatment Period: Placebo	6
Double-Blind Treatment Period (6 Weeks)	STARTED	Double-blind Treatment Period: RVT-1401 340 mg/Week	5
Double-Blind Treatment Period (6 Weeks)	STARTED	Double-blind Treatment Period: RVT-1401 680 mg/Week	6
Double-Blind Treatment Period (6 Weeks)	STARTED	Open-label Extension Period: RVT-1401 340 mg Biweekly	0
Double-Blind Treatment Period (6 Weeks)	COMPLETED	Double-blind Treatment Period: Placebo	6
Double-Blind Treatment Period (6 Weeks)	COMPLETED	Double-blind Treatment Period: RVT-1401 340 mg/Week	5
Double-Blind Treatment Period (6 Weeks)	COMPLETED	Double-blind Treatment Period: RVT-1401 680 mg/Week	5
Double-Blind Treatment Period (6 Weeks)	COMPLETED	Open-label Extension Period: RVT-1401 340 mg Biweekly	0
Double-Blind Treatment Period (6 Weeks)	NOT COMPLETED	Double-blind Treatment Period: Placebo	0
Double-Blind Treatment Period (6 Weeks)	NOT COMPLETED	Double-blind Treatment Period: RVT-1401 340 mg/Week	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events156

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Gingival pain	Gastrointestinal disorders	Double-blind Treatment Period: Placebo	0	6
other	Gingival pain	Gastrointestinal disorders	Double-blind Treatment Period: RVT-1401 340 mg/Week	0	5
other	Gingival pain	Gastrointestinal disorders	Double-blind Treatment Period: RVT-1401 680 mg/Week	1	6
other	Gingival pain	Gastrointestinal disorders	Open-label Extension Period: RVT-1401 340 mg Biweekly	0	15
other	Anal incontinence	Gastrointestinal disorders	Double-blind Treatment Period: Placebo	1	6
other	Anal incontinence	Gastrointestinal disorders	Double-blind Treatment Period: RVT-1401 340 mg/Week	0	5
other	Anal incontinence	Gastrointestinal disorders	Double-blind Treatment Period: RVT-1401 680 mg/Week	0	6
other	Anal incontinence	Gastrointestinal disorders	Open-label Extension Period: RVT-1401 340 mg Biweekly	0	15
other	Constipation	Gastrointestinal disorders	Double-blind Treatment Period: Placebo	1	6
other	Constipation	Gastrointestinal disorders	Double-blind Treatment Period: RVT-1401 340 mg/Week	0	5

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Double-blind Treatment Period: Placebo	0	6
Total, all-cause mortality	Double-blind Treatment Period: RVT-1401 340 mg/Week	0	5
Total, all-cause mortality	Double-blind Treatment Period: RVT-1401 680 mg/Week	0	6
Total, all-cause mortality	Open-label Extension Period: RVT-1401 340 mg Biweekly	0	15
Total, other adverse events	Double-blind Treatment Period: Placebo	5	6
Total, other adverse events	Double-blind Treatment Period: RVT-1401 340 mg/Week	4	5
Total, other adverse events	Double-blind Treatment Period: RVT-1401 680 mg/Week	5	6
Total, other adverse events	Open-label Extension Period: RVT-1401 340 mg Biweekly	10	15
Total, serious adverse events	Double-blind Treatment Period: Placebo	0	6
Total, serious adverse events	Double-blind Treatment Period: RVT-1401 340 mg/Week	0	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03863080

GET https://conductscience.org/api/trials/v1/NCT03863080/registered?page=2

API reference For AI assistants