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PEGylated Uricase Enzyme

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy (COMPARE Trial)

Phase 2
Waitlist Available
Research Sponsored by Selecta Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of month 3, baseline to end of month 6
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Gout

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of month 3, baseline to end of month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of month 3, baseline to end of month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
Secondary study objectives
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale

Side effects data

From 2019 Phase 2 trial • 152 Patients • NCT02959918
100%
Gout flare
33%
Anaphylactic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
SEL-037 (Pegadricase) Low Dose
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-037 (Pegadricase) High Dose
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SEL-212Experimental Treatment1 Intervention
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
Group II: KRYSTEXXAActive Control1 Intervention
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEL-212
2016
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Selecta Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
656 Total Patients Enrolled
5 Trials studying Gout
502 Patients Enrolled for Gout
Medical DirectorStudy DirectorSelecta Biosciences, Inc.
2,900 Previous Clinical Trials
8,090,264 Total Patients Enrolled
12 Trials studying Gout
5,818 Patients Enrolled for Gout
~26 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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