Trial · NCT03938545
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
NCT03938545, Phase 2, Terminated, Immunovant Sciences GmbH; results first posted 2022-09-22
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO ). Trials, record NCT03938545. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03938545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
- NCT number
- NCT03938545
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Immunovant Sciences GmbH
- Conditions
- Graves' Ophthalmopathy (GO)
- Interventions
- RVT-1401 (Administered via subcutaneous injection), Placebo (Administered via subcutaneous injection)
- First posted
- 2019-05-06
- Last updated
- 2022-09-22
- Results first posted
- 2022-09-22
- Limitations and caveats
- The study was terminated early due to a safety finding (hypercholesterolemia).
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Proptosis Response at Week 13 | Baseline; Week 13 | Proptosis was assessed using an exophthalmometer. A proptosis response was defined as having at least a 2 millimeter (mm) reduction in study eye proptosis without a deterioration (at least a 2 mm increase) in the fellow eye at the same visit. The study eye was defined as the most severely affected eye at the baseline visit. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | From Baseline up to Week 20 | AEs - any untoward medical occurrences in a participant, temporally associated with use of a medicinal product, whether or not considered related to the product. Clinically significant changes determined by the Investigator such as vital signs, ECGs, and clinical laboratory values were also reported as AEs. TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug. SAEs were defined as any untoward medical occurrences that: resulted in death; were life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; were congenital anomaly/birth defects; were important medical events that may have jeopardized the participant or may have required medical or surgical intervention; invasive or malignant cancers; and development of drug dependency or drug abuse. |
| Secondary | Least Square Mean Percent Change From Baseline in Binding Anti-thyroid-stimulating Hormone Receptor (TSHR) Antibody Levels to Week 13 | Baseline and Week 13 | Binding Anti-TSHR antibody serum levels are directly associated with GO clinical features. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in binding anti-TSHR antibody levels indicated therapeutic benefit. |
| Secondary | Least Square Mean Percent Change From Baseline in Total IgG Levels | Baseline and Week 13 | Blood samples we collected to determine total IgG levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit. |
| Secondary | Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 | Baseline and Week 13 | Blood samples were collected to determine IgG 1,2,3 and 4 levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Proptosis Response at Week 13 | Baseline; Week 13 | Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of RVT-1401 or placebo and had 1 post-baseline visit. Participants with proptosis assessment at Week 13 were included in the analysis. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | From Baseline up to Week 20 | Safety Population: All randomized participants who received at least one dose of either RVT-1401 or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Least Square Mean Percent Change From Baseline in Binding Anti-thyroid-stimulating Hormone Receptor (TSHR) Antibody Levels to Week 13 | Baseline and Week 13 | ITT Population. Participants with binding anti-TSHR serum assessments at Week 13 were included in the analysis. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Square Mean Percent Change From Baseline in Total IgG Levels | Baseline and Week 13 | ITT Population: Participants with evaluable data were included for the analysis. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 | Baseline and Week 13 | ITT Population. Participants with evaluable data were included for the analysis. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Proptosis Response at Week 13 | RVT-1401 680 mg/Week | 30.0 | Percentage of participants | ||
| Percentage of Participants With Proptosis Response at Week 13 | RVT-1401 340 mg/Week | 30.8 | Percentage of participants | ||
| Percentage of Participants With Proptosis Response at Week 13 | RVT-1401 255 mg/Week | 0 | Percentage of participants | ||
| Percentage of Participants With Proptosis Response at Week 13 | Placebo | 8.3 | Percentage of participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | RVT-1401 680 mg/Week | TEAEs | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | RVT-1401 340 mg/Week | TEAEs | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | RVT-1401 255 mg/Week | TEAEs | 8 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | Placebo | TEAEs | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | RVT-1401 680 mg/Week | SAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | RVT-1401 340 mg/Week | SAEs | 0 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RVT-1401 680 mg/Week | 18 | |
| Overall Study | STARTED | RVT-1401 340 mg/Week | 19 | |
| Overall Study | STARTED | RVT-1401 255 mg/Week | 10 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | RVT-1401 680 mg/Week | 10 | |
| Overall Study | COMPLETED | RVT-1401 340 mg/Week | 14 | |
| Overall Study | COMPLETED | RVT-1401 255 mg/Week | 7 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | RVT-1401 680 mg/Week | 8 | |
| Overall Study | NOT COMPLETED | RVT-1401 340 mg/Week | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events328
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 | Lymphadenopathy | Blood and lymphatic system disorders | RVT-1401 680 mg/Week | 0 | 18 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | RVT-1401 340 mg/Week | 0 | 19 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | RVT-1401 255 mg/Week | 1 | 10 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Palpitations | Cardiac disorders | RVT-1401 680 mg/Week | 1 | 18 | 1 |
| other | Palpitations | Cardiac disorders | RVT-1401 340 mg/Week | 0 | 19 | 0 |
| other | Palpitations | Cardiac disorders | RVT-1401 255 mg/Week | 0 | 10 | 0 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 18 | 0 |
| other | Ear pain | Ear and labyrinth disorders | RVT-1401 680 mg/Week | 0 | 18 | 0 |
| other | Ear pain | Ear and labyrinth disorders | RVT-1401 340 mg/Week | 0 | 19 | 0 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RVT-1401 680 mg/Week | 0 | 18 |
| Total, all-cause mortality | RVT-1401 340 mg/Week | 0 | 19 |
| Total, all-cause mortality | RVT-1401 255 mg/Week | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | RVT-1401 680 mg/Week | 16 | 18 |
| Total, other adverse events | RVT-1401 340 mg/Week | 16 | 19 |
| Total, other adverse events | RVT-1401 255 mg/Week | 8 | 10 |
| Total, other adverse events | Placebo | 16 | 18 |
| Total, serious adverse events | RVT-1401 680 mg/Week | 0 | 18 |
| Total, serious adverse events | RVT-1401 340 mg/Week | 0 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT03938545
GET https://conductscience.org/api/trials/v1/NCT03938545/results?page=2