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A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

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Trial Profile

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Oct 2025

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At a glance

  • Drugs SEL 212 (Primary)
  • Indications Gout
  • Focus Registrational; Therapeutic Use
  • Acronyms DISSOLVE II
  • Sponsors Selecta Biosciences

Most Recent Events

  • 10 Sep 2025 According to a Swedish Orphan Biovitrum media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) seeking approval for Nanoecapsulated Sirolimus plus Pegadricase (NASP), formerly SEL-212, for the treatment of uncontrolled gout. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date of 27 June 2026, based on results from the Phase 3 DISSOLVE I & II.
  • 15 Jun 2024 Results of pooled analysis describing the combined efficacy and safety data for SEL-212 from the 6-month DISSOLVE-I & II studies, presented at the 25th Annual Congress of the European League Against Rheumatism
  • 15 Nov 2023 Pooled analysis results of DISSOLVE I and II trials assessing Safety & Efficacy of SEL-212 in Patients with Gout Refractory to Conventional Treatment, were presented at the ACR Convergence 2023

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