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PEGylated Uricase Enzyme
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy (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
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
100 Previous Clinical Trials
13,036 Total Patients Enrolled
1 Trials studying Gout
153 Patients Enrolled for Gout
Selecta Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
714 Total Patients Enrolled
5 Trials studying Gout
560 Patients Enrolled for Gout