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NCT03938545 · ClinicalTrials.gov registry record · Phase 2
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
A Phase 2 study, sponsored by Immunovant Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT03938545: Clinical Trial Phase 2 study, sponsored by Immunovant Sciences.
NCT03938545 is a Phase 2 study that was terminated before completion, run by Immunovant Sciences. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03938545, a Phase 2 study, was terminated before completion, sponsored by Immunovant Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG
Primary Outcome
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.
Interventions
- DRUG RVT-1401 (Administered via subcutaneous injection)
- OTHER Placebo (Administered via subcutaneous injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 2 |
Why NCT03938545 stopped before completion
NCT03938545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which RVT-1401 (Administered via subcutaneous injection) is the first listed.
NCT03938545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03938545 about?
NCT03938545 is a clinical study titled "ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )". The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG
What is the current status of trial NCT03938545?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2019-07-23. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT03938545?
The interventions under investigation include: RVT-1401 (Administered via subcutaneous injection) (DRUG), Placebo (Administered via subcutaneous injection) (OTHER).
Who is sponsoring clinical trial NCT03938545?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03938545's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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