Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 153 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04596540
The ClinicalTrials.gov registry entry for NCT04596540 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Swedish Orphan Biovitrum, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04596540 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.