Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-30 @ 11:33 PM
Study NCT ID:
NCT03895203
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Sponsor:
UCB Biopharma SRL
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2025-06
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:
BE OPTIMAL
Brief Summary:
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-002322-20 | EUDRACT_NUMBER | None | View |