A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy (DISSOLVE I Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Swedish Orphan Biovitrum

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Treatment Details

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