A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
Public ClinicalTrials.gov record NCT04596540. 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 were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Study identification
- NCT ID
- NCT04596540
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 153 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
- Nov 30, 2020 (Actual)
- Primary completion
- Jan 10, 2023 (Actual)
- Completion
- Jan 12, 2023 (Actual)
- Last update posted
- Dec 3, 2025
2020 – 2023
United States locations
- U.S. sites
- 30
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Of West Florida Incorporated | Clearwater | Florida | 33765 | — |
| Omegas Research Consultants LLC | DeBary | Florida | 32713 | — |
| Sweet Hope Research Specialty, Inc | Hialeah | Florida | 33016 | — |
| Homestead Associates in Research,Inc | Miami | Florida | 33032 | — |
| D&H National Research Centers | Miami | Florida | 33155 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Napa Research | Pompano Beach | Florida | 33064 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Horizon Clinical Research | Fayetteville | Georgia | 30214 | — |
| Arthritis Center of North Georgia, LLC | Gainesville | Georgia | 30501 | — |
| Injury Care Medical Center | Boise | Idaho | 83713 | — |
| Great Lakes Clinical Trials at Ravenswood Rheumatology | Chicago | Illinois | 60640 | — |
| Great Lakes Clinical Trials LLC | Chicago | Illinois | 60640 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| University Of Michigan | Ann Arbor | Michigan | 48109 | — |
| Elite Clinical Research, LLC | Jackson | Mississippi | 39202 | — |
| Rutgers- New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Medication Management of Greensboro | Greensboro | North Carolina | 27408 | — |
| Triad Clinical Trials | Greensboro | North Carolina | 27410 | — |
| Carolina Research Center, Inc | Shelby | North Carolina | 28150 | — |
| META Medical Research Institute LLC | Dayton | Ohio | 45432 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| New Phase Research and Development | Knoxville | Tennessee | 37909 | — |
| Amarillo Center for Clinical Research, Ltd. | Amarillo | Texas | 79124 | — |
| Heritage Rheumatology and Arthritis Care | Colleyville | Texas | 76034 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | — |
| AIM Trials - Internal Medicine | Plano | Texas | 75074 | — |
| Arthritis Northwest, PLLC - Research | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04596540, 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 Dec 3, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04596540 live on ClinicalTrials.gov.