A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Public ClinicalTrials.gov record NCT04513366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04513366
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 112 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2020 (Actual)
- Primary completion
- Jul 21, 2022 (Actual)
- Completion
- Dec 1, 2022 (Actual)
- Last update posted
- Sep 11, 2025
2020 – 2022
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Sun City | Arizona | 85351 | — |
| Medvin Clinical Research | Covina | California | 91722 | — |
| Valerius Medical Group & Research Center | Los Alamitos | California | 90720 | — |
| ACRC Studies | Poway | California | 92064 | — |
| MD Strategies Research Center | San Diego | California | 92119 | — |
| Tekton Research - Fort Collins | Fort Collins | Colorado | 80528 | — |
| Helix Biomedics, LLC | Boynton Beach | Florida | 33435 | — |
| Clinical Research Of West Florida Incorporated | Clearwater | Florida | 33765 | — |
| Omegas Research Consultants LLC | DeBary | Florida | 32713 | — |
| Riverside Clinical Research | Edgewater | Florida | 32132 | — |
| Homestead Associates in Research,Inc | Homestead | Florida | 33032 | — |
| Health Awareness INC | Jupiter | Florida | 33458 | — |
| Y & L Advance Health Care, Inc | Miami | Florida | 33144 | — |
| Well Pharma Medical Research, Corp | Miami | Florida | 33173 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian | Meridian | Idaho | 83642 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | — |
| Klein and Associates, M.D., P.A. | Cumberland | Maryland | 21502 | — |
| Klein and Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| Elite Clinical Research, LLC | Jackson | Mississippi | 39216 | — |
| Arthritis Consultants, Inc. | St Louis | Missouri | 63141 | — |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | — |
| Medex Healthcare Research, Inc. | New York | New York | 10036 | — |
| CFA - Cape Fear Arthritis Care, PLLC | Leland | North Carolina | 28451 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Arthritis & Rheumatology Center of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73102 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | — |
| AIM Trials - Internal Medicine | Plano | Texas | 75234 | — |
| Epic Medical Research | Red Oak | Texas | 75154 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04513366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04513366 live on ClinicalTrials.gov.