Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-01-01 @ 9:37 PM
Study NCT ID:
NCT05814159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Sponsor:
Swedish Orphan Biovitrum
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of Subcutaneous Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
None
Brief Summary:
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis \[SJIA\] and Adult-onset Still's disease \[AOSD\]).
Detailed Description:
The study consists of two phases:
• Core phase comprising 2 weeks double blind placebo-controlled treatment, 52 weeks open label treatment and 4 weeks safety follow up (only for patients not entering the extension phase).
At the Week 54 visit, patients who consent and are eligible to continue anakinra treatment, will enter the extension phase and continue open label anakinra treatment.
• Extension phase comprising up to 26 weeks open label treatment and 4 weeks safety follow up.
The primary endpoint will be evaluated at Week 2 visit.
• Core phase comprising 2 weeks double blind placebo-controlled treatment, 52 weeks open label treatment and 4 weeks safety follow up (only for patients not entering the extension phase).
At the Week 54 visit, patients who consent and are eligible to continue anakinra treatment, will enter the extension phase and continue open label anakinra treatment.
• Extension phase comprising up to 26 weeks open label treatment and 4 weeks safety follow up.
The primary endpoint will be evaluated at Week 2 visit.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: