Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513366
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2020-08-07
Brief Title:
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISSOLVE I
Brief 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 111 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-212301 and SEL-212302 Analysis of primary and key efficacy will be performed at Day 28 of Treatment Period 6 Safety was monitored throughout the study
Detailed 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 111 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-212301 and SEL-212302 The SEL-212 doses differed as to the SEL-11036 component Participants received SEL-037 administered at a dose of 02 mgkg via intravenous IV infusion immediately after receiving SEL-11036 at a dose of either 01 mgkg SEL-212 low-dose or 015 mgkg 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-212301 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-212303
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
Upon completion of the 6-month double-blinded placebo-controlled portion of the study SEL-212301 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-212303
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None