A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Completed · Phase 2
Conditions studied: Chronic Gout
In brief
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.
Key facts
- Study ID
- NCT03905512
- Run by
- Selecta Biosciences, Inc.
- People needed
- 170
- Starts
- 2019-05-07
- Expected to finish
- 2020-08-05
- Last updated by the study team
- 2023-10-17
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pinnacle Research Group, LLC — Anniston, Alabama, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Sun City, Arizona, United States
- Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
- Medvin Clinical Research — Covina, California, United States
- Valerius Medical Group and Research Center of Greater Long Beach, Inc. — Los Alamitos, California, United States
- Arthritis Care and Research Center — Poway, California, United States
- MD Strategies Research Centers — San Diego, California, United States
- Clinical Research of West Florida — Clearwater, Florida, United States
- QPS-Medical Research Assoc LLC — Miami, Florida, United States
- Well Pharma Medical Research Corp. — Miami, Florida, United States
- Panax Clinical Research — Miami Lakes, Florida, United States
- Accelerated Enrollment Solutions (AES) — Orlando, Florida, United States
- Rheumatology Associates of Central Florida, PA — Orlando, Florida, United States
- Clinical Research of West Florida, Inc. — Tampa, Florida, United States
- Advent Health Group Multispecialty at Habana and Bruce B. Downs — Tampa, Florida, United States
- Arthritis Center of North Georgia — Gainesville, Georgia, United States
- Better Health Clinical Research, Inc. — Newnan, Georgia, United States
- Institute of Arthritis Research — Idaho Falls, Idaho, United States
- Great Lakes Clinical Trials — Chicago, Illinois, United States
- L-MARC Research Center — Louisville, Kentucky, United States
- Klein & Associates, M.D., P.A. — Cumberland, Maryland, United States
- Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States
- The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
- Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
- University Hospital — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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