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PEGylated Uricase Enzyme

SEL-212 low-dose for Gout (DISSOLVE I Trial)

Phase 3
Waitlist Available
Research Sponsored by Swedish Orphan Biovitrum
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 6 months
Awards & highlights

Summary

This trial tests SEL-212, an IV treatment for severe gout patients with painful lumps called tophi. It combines two substances to help break down and remove harmful crystals causing pain and swelling. SEL-212 includes pegloticase, a medication previously used for treating severe gout, especially in patients who have not responded to other treatments.

Eligible Conditions
  • Gout

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum uric acid control during month 6
Secondary study objectives
Gout Flare Incidence
HAQ-DI
Percent reduction of mean serum uric acid
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEL-212 low-doseExperimental Treatment1 Intervention
SEL-212 low-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.1 mg/kg) SEL-110.36, ImmTOR
Group II: SEL-212 high-doseExperimental Treatment1 Intervention
SEL-212 high-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.15 mg/kg) SEL-110.36, ImmTOR
Group III: PlaceboPlacebo Group1 Intervention
Normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEL-212 low-dose
2020
Completed Phase 3
~270
SEL-212 high-dose
2020
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

Swedish Orphan BiovitrumLead Sponsor
96 Previous Clinical Trials
12,552 Total Patients Enrolled
1 Trials studying Gout
153 Patients Enrolled for Gout
Selecta Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
720 Total Patients Enrolled
5 Trials studying Gout
560 Patients Enrolled for Gout
~22 spots leftby Sep 2025
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