Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 5:42 PM
Study NCT ID:
NCT04728360
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2021-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis
Sponsor:
Bio-Thera Solutions
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2022-08
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:
This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis.
The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.
The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: