A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
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 was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Timeline
- Start
- 2020-08-18
- Primary completion
- 2022-07-21
- Completion
- 2022-12-01
Outcome
Met primary endpoint
registry analysis (superiority test); SEL-212A (Low-dose) vs Placebo; p <.0001; Risk Difference (RD) 0.44 (97.5% CI 0.23 to 0.64); Mantel Haenszel NCT04513366 ↗
registry analysis (superiority test); SEL-212B (High-dose) vs Placebo; p <.0001; Risk Difference (RD) 0.53 (97.5% CI 0.32 to 0.73); Mantel Haenszel NCT04513366 ↗
release “DISSOLVE I had a statistically significant higher response rate of SEL-212 during month six : 56% and 48% of patients randomized to receive SEL-212” sobi.com ↗
release “versus 4% of patients randomized to receive the placebo reached the primary endpoint” 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 |