Trial · NCT03922321
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)
NCT03922321, Phase 2, Completed, Immunovant Sciences GmbH; results first posted 2022-01-24
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO). Trials, record NCT03922321. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03922321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)
- NCT number
- NCT03922321
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Immunovant Sciences GmbH
- Conditions
- Graves' Ophthalmopathy
- Interventions
- RVT-1401
- First posted
- 2019-04-19
- Last updated
- 2022-01-24
- Results first posted
- 2022-01-24
- Limitations and caveats
- The PK parameters of AUC0-168h and Cmax were not estimated because of sparse PK sampling schedule.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | from Baseline up to Week 6 | 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. |
| Primary | Number of Participants With Clinically Significant Findings Related to Vital Signs | up to Week 18 | Clinical significance was determined by the investigator. |
| Primary | Number of Participants With a Change From Normal Physical Examination Findings at Baseline to Abnormal Physical Examination Findings at the End of the Study | up to Week 18 | Abnormality was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Findings Related to Electrocardiograms (ECGs) | up to Week 18 | Clinical significance was determined by the investigator. |
| Primary | Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | Baseline; Week 7; Week 6 and 7 combined | 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. |
| Primary | Mean Change From Baseline in Levels of Anti-thyroid-stimulating Hormone Receptor (Anti-TSHR) Antibodies at Week 7 | Baseline; Week 7 | 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. |
| Secondary | Mean Change From Baseline in Proptosis in the Study Eye and Non-study Eye at Week 7 | Baseline; Week 7 | The study eye was defined as the most severely affected eye at the Baseline visit. In the event that both eyes were affected the same, the right eye was deemed as the study eye. Participants who did not achieve a proptosis response were censored at the date of their last proptosis measurement that occurred in both eyes. Change from Baseline was calculated as the Week 7 value minus the Baseline value. A negative change from Baseline represents clinical improvement. |
| Secondary | Number of Participants With an Overall Proptosis Response | Up to Week 18 | Proptosis responders were defined as participants with a ≥2 mm reduction in study eye without deterioration (≥2 mm increase) in the fellow eye. Participants who did not achieve a proptosis response were censored at the date of their last proptosis measurement that occurred in both eyes. |
| Secondary | Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | Pharmacokinetic (PK) parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters. |
| Secondary | Maximum Concentration (Cmax) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | PK parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | from Baseline up to Week 6 | Safety Population: all participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Findings Related to Vital Signs | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Change From Normal Physical Examination Findings at Baseline to Abnormal Physical Examination Findings at the End of the Study | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Findings Related to Electrocardiograms (ECGs) | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | Baseline; Week 7; Week 6 and 7 combined | Pharmacodynamic (PD) Population: all participants who had a Baseline PD measurement and at least 1 post-Baseline PD measurement and received at least 1 dose of study drug. Only participants with available data were analyzed. | Percent change | MEAN |
| PRIMARY | Mean Change From Baseline in Levels of Anti-thyroid-stimulating Hormone Receptor (Anti-TSHR) Antibodies at Week 7 | Baseline; Week 7 | PD Population. Only participants with available data were analyzed. | international units/milliliter (IU/mL) | MEAN |
| SECONDARY | Mean Change From Baseline in Proptosis in the Study Eye and Non-study Eye at Week 7 | Baseline; Week 7 | PD Population. Only participants with available data were analyzed. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants With an Overall Proptosis Response | Up to Week 18 | PD Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | PK Population: all participants who received at least one dose of study drug and had at least 1 post-dose PK sample assayed for RVT-1401. Only 2 non-Ctrough time point samples were collected after the first dose (on Day 3 and Day 5) and last dose (on Day 38 and Day 40). As a result, having 2 sparse time point samples did not allow to accurately estimate AUC0-168h parameter. | ||
| SECONDARY | Maximum Concentration (Cmax) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | PK Population. PK parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters. Only 2 non-Ctrough time point samples were collected after the first dose (on Day 3 and Day 5) and last dose (on Day 38 and Day 40). As a result, having 2 sparse time point samples did not allow to accurately estimate Cmax parameter. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | RVT-1401 | TEAEs | 7 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | RVT-1401 | SAEs | 0 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | RVT-1401 | Treatment-related AEs | 6 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | RVT-1401 | Deaths | 0 | Participants | |
| Number of Participants With Clinically Significant Findings Related to Vital Signs | RVT-1401 | 0 | Participants | ||
| Number of Participants With a Change From Normal Physical Examination Findings at Baseline to Abnormal Physical Examination Findings at the End of the Study | RVT-1401 | 0 | Participants | ||
| Number of Participants With Clinically Significant Findings Related to Electrocardiograms (ECGs) | RVT-1401 | 0 | Participants | ||
| Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | RVT-1401 | Total IgG (Week 6 and 7 combined) | -65.00 | Standard Deviation 10.78 | Percent change |
| Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | RVT-1401 | Total IgG (Week 7) | -64.83 | Standard Deviation 17.65 | Percent change |
| Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | RVT-1401 | IgG1 (Week 7) | -67.16 | Standard Deviation 18.89 | Percent change |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RVT-1401 | 7 | |
| Overall Study | COMPLETED | RVT-1401 | 5 | |
| Overall Study | NOT COMPLETED | RVT-1401 | 2 |
Source ClinicalTrials.gov
Adverse events18
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 | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | RVT-1401 | 1 | 7 | |
| other | Lacrimation increased | Eye disorders | RVT-1401 | 2 | 7 | |
| other | Eye swelling | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Ocular hyperaemia | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Swelling of eyelid | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Keratopathy | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Eye pain | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Eye irritation | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Superior limbic keratoconjunctivitis | Eye disorders | RVT-1401 | 1 | 7 | |
| other | Diplopia | Eye disorders | RVT-1401 | 1 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RVT-1401 | 0 | 7 |
| Total, other adverse events | RVT-1401 | 7 | 7 |
| Total, serious adverse events | RVT-1401 | 0 | 7 |
Source ClinicalTrials.gov
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/NCT03922321
GET https://conductscience.org/api/trials/v1/NCT03922321/results?page=2