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COMPLETED Phase 3

A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

NCT04513366 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 112 participants
Start Date 2020-08-18
Est. Completion 2022-12-01
Phase Phase 3

Sponsor

Swedish Orphan Biovitrum

38 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04513366 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04513366?

This trial is sponsored by Swedish Orphan Biovitrum, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial