A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

Study Purpose

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Patients 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. History of symptomatic gout defined as: 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 ≥ 8 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 maximum 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:

1. Prior exposure to any experimental or marketed uricase (e.g., pegloticase [Krystexxa®], pegadricase [SEL-037], rasburicase [Elitek, Fasturtec]); 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. Patients 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03905512
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Selecta Biosciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Gout

Additional Details

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Patients will be randomized 1:1 to receive treatment with SEL-212 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA® for 6 months. Study patients in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study patients 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.

Arms & Interventions

Arms

Experimental: SEL-212

IV infusion of SEL-212 every 28 days for a total of up to 6 infusions of SEL-212.

Active Comparator: KRYSTEXXA

IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for a total of up to 12 infusions of KRYSTEXXA®.

Interventions

Drug: - SEL-212

SEL-212

Drug: - SEL-037

SEL-037, PEGylated uric acid specific enzyme (uricase)

Drug: - SEL-110

ImmTOR (SEL-110)

Drug: - KRYSTEXXA®

KRYSTEXXA®, PEGylated uric acid specific enzyme (uricase)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, LLC, Anniston, Alabama

Status

Recruiting

Address

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

Site Contact

Kendra Campbell

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