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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

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

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

Awards & 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