Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526377
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-15
Brief Title:
Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Double Blind Placebo Controlled Randomized Study Examining Natrunix in Combination With Standard of Care in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double-blind placebo-controlled randomized trial of Natrunix in combination with Standard of Care in patients with Axial Spondyloarthritis
Detailed Description:
This is Double-blind placebo-controlled randomized trial examining Natrunix in combination with Standard of Care Qualified subjects will be consented and screened for study eligibility and enrollment Enrolled subjects will be randomized in a 21 ratio to receive either 400 mg Natrunix or placebo All subjects who enter the study must be on a stable background standard of care SOC that they were receiving for at least 8 weeks prior to study enrollment Enrolled subjects must meet 2009 Assessment of SpondyloArthritis international Society ASAS classification criteria for axial spondyloarthritis be HLA-B27 positive and have active disease as defined by a BASDAI score 4 or an ASDAS-CRP 21 Subjects will receive once weekly injection of Natrunix or placebo in addition to SOC for 12 weeks The study will conclude after 12 weeks followed by a 12-week open label extension phase and one-week follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None