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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04513366
Other study ID # SEL-212/301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 18, 2020
Est. completion date December 1, 2022

Study information

Verified date February 2024
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 will be performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.


Description:

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). The SEL-212 doses differed as to the SEL-110.36 component. Participants received SEL-037 administered at a dose of 0.2 mg/kg via intravenous (IV) infusion immediately after receiving SEL-110.36 at a dose of either 0.1 mg/kg (SEL-212 low-dose) or 0.15 mg/kg (SEL-212 hig-dose) via IV infusion. The placebo consisted of normal saline. Upon completion of the 6-month double-blinded, placebo-controlled portion of the study, SEL-212/301 continued in a blinded, placebo-controlled 6-month extension. This provided up to 12 months of continuous treatment with SEL-212 in a placebo controlled fashion. Placebo subjects who completed both phases of the study will be offered enrollment in an open-label extension study for treatment with SEL-212 (SEL-212/303). Efficacy assessments were conducted at intervals that are appropriate to determine treatment effect with samples for the primary endpoint drawn during Treatment Period 6. Safety was monitored throughout the study with an independent data safety monitoring board (DSMB).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SEL-212 low-dose
IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions
SEL-212 high-dose
IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions
Other:
Normal Saline
IV infusion of Normal Saline every 28 days for a total of up to 12 infusions

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Sponsors (1)

Lead Sponsor Collaborator
Swedish Orphan Biovitrum

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum uric acid control during month 6 The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Reduction of mean serum uric acid To assess changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Percent reduction of mean serum uric acid To assess percent changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary SF-36 To assess change in Patient Reported Outcomes (PROs) including assessments of: patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Tophus burden To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Serum uric acid control in patients with tophi To assess change in the percentage of patients with tophi at baseline who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Tender and Swollen Joint Counts To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary HAQ-DI To assess change in Patient Reported Outcomes (PROs) including assessments of: activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
Secondary Gout Flare Incidence To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo 6 months
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