Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641076
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Parallel-group Randomized Double-blind 3-arm Placebo-controlled Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
IZAR-1
Brief Summary:
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy
Detailed Description:
M1095-PSA-301 is a Phase 3 multicenter randomized parallel-group double-blind 3-arm placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks with and without an induction regimen versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy
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