A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
NCT ID: NCT03905512
Last Updated: 2023-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2019-05-07
2020-08-05
Brief Summary
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Detailed Description
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Study participants in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study participants in the KRYSTEXXA® arm will receive study drug according to the manufacturer's prescribing information, i.e., every 14 days for a total of up to 12 infusions of KRYSTEXXA®.
Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SEL-212
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
SEL-212
Administered as specified in the treatment arm
KRYSTEXXA
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
KRYSTEXXA®
Administered as specified in the treatment arm
Interventions
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SEL-212
Administered as specified in the treatment arm
KRYSTEXXA®
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. ≥ 3 gout flares within 18 months of Screening or
2. Presence of ≥ 1 tophus or
3. Current diagnosis of gouty arthritis
2. At the Screening Visit: male age 21 - 80 years, inclusive, or female of non-childbearing potential age 21-80 years, inclusive, where non-childbearing potential is defined as:
1. \> 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or
2. Post-menopausal (\> 24 months of natural amenorrhea)
3. Has at the Screening Visit SUA ≥ 7 mg/dL, with chronic refractory gout defined as having failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the medically appropriate dose or for whom these drugs are contraindicated;
4. Willing to provide written informed consent prior to the conduct of any study specific procedures;
5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits
Exclusion Criteria
2. History of anaphylaxis or severe allergic reactions to medications;
3. History of any allergy to pegylated products
4. Drugs known to interact with Rapamune cannot be used during the trial;
5. Uncontrolled diabetes;
6. Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
7. Uncontrolled hypertension;
8. Participants whose arrhythmia is unstable on current treatment;
9. History of coronary artery disease, including myocardial infarction or unstable angina, within the last 6 months;
10. Congestive heart failure;
11. History of hematological disorders within 1 year or autoimmune disorders, is immunosuppressed or immunocompromised;
12. Has received an inactivated vaccine in the previous 3 months or has received a live virus vaccine in the previous 6 months;
13. Is planning to receive any vaccination or live virus vaccination during the study;
21 Years
80 Years
ALL
No
Sponsors
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Selecta Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Selecta Biosciences, Inc.
Locations
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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
Elite Clinical Research, LLC
Jackson, Mississippi, United States
TEST
Blue Springs, Missouri, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cape Fear Arthritis Care PLLC
Leland, North Carolina, United States
Cape Fear Arthritis Care PLLC
Leland, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Arthritis & Rheumatology Center of Oklamhoma, PLLC
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
West Tennessee Research Institute, LLC
Jackson, Tennessee, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
Countries
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References
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Baraf HSB, Khanna PP, Kivitz AJ, Strand V, Choi HK, Terkeltaub R, Dalbeth N, DeHaan W, Azeem R, Traber PG, Keenan RT. The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR) versus pegloticase for refractory gout. Rheumatology (Oxford). 2024 Apr 2;63(4):1058-1067. doi: 10.1093/rheumatology/kead333.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SEL-212/202
Identifier Type: -
Identifier Source: org_study_id
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