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NCT03905512 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
A Phase 2 study of Chronic Gout, sponsored by Selecta Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 20
- Study locations
NCT03905512 is a Phase 2 study of Chronic Gout that has completed, run by Selecta Biosciences. The registered enrollment target is 170 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT03905512, a Phase 2 study of Chronic Gout, has completed, sponsored by Selecta Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
Conditions Studied
Interventions
- DRUG SEL-212
- DRUG KRYSTEXXA®
Study Locations (20)
Florida
- Clinical Research of West Florida - Clearwater
- QPS-Medical Research Assoc LLC - Miami
- Well Pharma Medical Research Corp. - Miami
- Panax Clinical Research - Miami Lakes
- Accelerated Enrollment Solutions (AES) - Orlando
- Rheumatology Associates of Central Florida, PA - Orlando
- Clinical Research of West Florida, Inc. - Tampa
- Advent Health Group Multispecialty at Habana and Bruce B. Downs - Tampa
California
- Medvin Clinical Research - Covina
- Valerius Medical Group and Research Center of Greater Long Beach, Inc. - Los Alamitos
- Arthritis Care and Research Center - Poway
- MD Strategies Research Centers - San Diego
Georgia
- Arthritis Center of North Georgia - Gainesville
- Better Health Clinical Research, Inc. - Newnan
Alabama
- Pinnacle Research Group, LLC - Anniston
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Sun City
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
Idaho
- Institute of Arthritis Research - Idaho Falls
Illinois
- Great Lakes Clinical Trials - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2020-08-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03905512
The ClinicalTrials.gov registry entry for NCT03905512 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Selecta Biosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Gout appearing as the primary indexed condition, and to 2 interventions - of which SEL-212 is the first listed.
NCT03905512 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03905512 about?
NCT03905512 is a clinical study titled "A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy". This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be co...
What is the current status of trial NCT03905512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2019-05-07. Estimated completion is 2020-08-05.
What conditions does trial NCT03905512 study?
This clinical trial studies the following conditions: Chronic Gout.
What interventions are being tested in trial NCT03905512?
The interventions under investigation include: SEL-212 (DRUG), KRYSTEXXA® (DRUG).
Who is sponsoring clinical trial NCT03905512?
This trial is sponsored by Selecta Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03905512 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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