A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
Summary
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Timeline
- Start
- 2020-11-30
- Primary completion
- 2023-01-10
- Completion
- 2023-01-12
Outcome
Met primary endpoint
registry analysis (superiority test); SEL-212A (Low-dose) vs Placebo; p = 0.0008; Risk Difference (RD) 0.29 (97.5% CI 0.10 to 0.48); Mantel Haenszel NCT04596540 ↗
registry analysis (superiority test); SEL-212B (High-dose) vs Placebo; p = 0.0002; Risk Difference (RD) 0.35 (97.5% CI 0.14 to 0.56); Mantel Haenszel NCT04596540 ↗
release “The DISSOLVE II (the “Global Study”) also met its primary endpoint, with 47% receiving monthly doses of SEL-212” sobi.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SEL-037 | Protein / enzyme biologic | 0.2 mg/kg | Intravenous |
| Subject | SEL-110.36 | Unknown | 0.1 mg/kg | Intravenous |
| Subject | SEL-110.36 | Unknown | 0.15 mg/kg | Intravenous |