SEL-037
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02648269 | Dec 2015 → Dec 2016 | gout | Selecta Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02464605 | May → Nov 2015 | gout | Selecta Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01038947 | Dec 2009 → Apr 2010 | gout | EnzymeRx | Unknown | No outcome recorded |
| Phase 1 | NCT01021241 | Oct 2009 → Mar 2010 | gout | EnzymeRx | Unknown | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03905512 | May 2019 → Aug 2020 | gout | Selecta Biosciences, Inc. | Completed | Missed primary |
| Phase 2 | NCT02959918 | Oct 2016 → Dec 2018 | gout | Selecta Biosciences, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT04596540 | Nov 2020 → Jan 2023 | gout | Swedish Orphan Biovitrum | Completed | Met primary |
| Phase 3 | NCT04513366 | Aug 2020 → Jul 2022 | gout | Swedish Orphan Biovitrum | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-03-21 | Sobi, Inc. | Results Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint sobi.com ↗
The DISSOLVE II (the “Global Study”) also met its primary endpoint, with 47% receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-03-21 | Sobi, Inc. | Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint sobi.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SEL-037 | “single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels” NCT02464605 ↗5“SEL-212 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA® for 6 months.” NCT03905512 ↗ “Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase)” NCT04596540 ↗ “SEL-037, PEGylated uric acid specific enzyme (uricase)” NCT04513366 ↗ “SEL-037; also known as pegadricase” NCT02959918 ↗ |
| Known as | Pegadricase | “SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout.” PMID 37449908 ↗ Apr 20242“SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase” NCT04513366 ↗ “SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase” NCT04596540 ↗ |
| Known as | pegsiticase | “SEL-037, PEGylated uric acid specific enzyme (uricase)
Other Names:
Pegadricase, pegsiticase” NCT04513366 ↗3“SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase” NCT04596540 ↗ “Single intravenous dose of SEL-037 (pegsiticase)” NCT02648269 ↗ |
| Known as | Uricase-PEG 20 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01021241 ↗ |
| Modality | Protein / enzyme biologic | “Uricase is an enzyme” NCT01021241 ↗ |
| Route | Intravenous | “Intravenous infusion of Uricase-PEG 20 over one hour” NCT01021241 ↗ |