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NCT04513366 · ClinicalTrials.gov registry record · Phase 3
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
A Phase 3 study of Chronic Gout, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT04513366 is a Phase 3 study of Chronic Gout that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 112 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT04513366, a Phase 3 study of Chronic Gout, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
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 was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Conditions Studied
Interventions
- OTHER Normal Saline
- DRUG SEL-212 low-dose
- DRUG SEL-212 high-dose
Study Locations (20)
Florida
- Helix Biomedics, LLC - Boynton Beach
- Clinical Research Of West Florida Incorporated - Clearwater
- Omegas Research Consultants LLC - DeBary
- Riverside Clinical Research - Edgewater
- Homestead Associates in Research,Inc - Homestead
- Health Awareness INC - Jupiter
- Y & L Advance Health Care, Inc - Miami
- Well Pharma Medical Research, Corp - Miami
- Panax Clinical Research - Miami Lakes
- Clinical Research of West Florida, Inc. - Tampa
- Conquest Research - Winter Park
California
- Medvin Clinical Research - Covina
- Valerius Medical Group & Research Center - Los Alamitos
- ACRC Studies - Poway
- MD Strategies Research Center - San Diego
Alabama
- Pinnacle Research Group - Anniston
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Sun City
Colorado
- Tekton Research - Fort Collins - Fort Collins
Georgia
- Better Health Clinical Research, Inc. - Newnan
Idaho
- Institute of Arthritis Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04513366
The ClinicalTrials.gov registry entry for NCT04513366 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 112 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 1 condition, with Chronic Gout appearing as the primary indexed condition, and to 3 interventions - of which Normal Saline is the first listed.
NCT04513366 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04513366 about?
NCT04513366 is a clinical study titled "A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy". 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 NCT04513366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2020-08-18. Estimated completion is 2022-12-01.
What conditions does trial NCT04513366 study?
This clinical trial studies the following conditions: Chronic Gout.
What interventions are being tested in trial NCT04513366?
The interventions under investigation include: Normal Saline (OTHER), SEL-212 low-dose (DRUG), SEL-212 high-dose (DRUG).
Who is sponsoring clinical trial NCT04513366?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04513366 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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