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NCT04596540 · ClinicalTrials.gov registry record · Phase 3
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
A Phase 3 study, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT04596540: Completed Phase 3 study, sponsored by Swedish Orphan Biovitrum.
NCT04596540 is a Phase 3 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596540, a Phase 3 study, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Interventions
- OTHER Placebo
- DRUG SEL-212 low-dose
- DRUG SEL-212 high-dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2023-01-12 |
| Phase | Phase 3 |
What the finished NCT04596540 record still lists
NCT04596540 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04596540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596540 about?
NCT04596540 is a clinical study titled "A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II". This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocat...
What is the current status of trial NCT04596540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2020-11-30. Estimated completion is 2023-01-12.
What interventions are being tested in trial NCT04596540?
The interventions under investigation include: Placebo (OTHER), SEL-212 low-dose (DRUG), SEL-212 high-dose (DRUG).
Who is sponsoring clinical trial NCT04596540?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596540's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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