Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637631
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multinational Multicenter Randomized Doubleblind Placebocontrolled Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohns Disease
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:
SPECIFI-CD
Brief Summary:
This is a phase 2 multinational multicenter randomized double-blind placebo-controlled dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohns Disease CD The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD
This study will include a screening period of 4 weeks 7 calendar days if needed followed by the Main Study MS treatment period lasting 52 weeks The MS period include a Double-Blind DB treatment period with 12 weeks of induction followed by 40 weeks of maintenance At the end of 52 weeks in the MS period eligible participants from MS period will be offered a Double-Blind Maintenance Extension DBME period for up to 52 weeks
Additionally an Open Label OL period of up to 92 weeks will be offered to eligible participants The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks while the sum of the DBME and OL periods may not exceed 52 weeks depending on when participants switch
This study will include a screening period of 4 weeks 7 calendar days if needed followed by the Main Study MS treatment period lasting 52 weeks The MS period include a Double-Blind DB treatment period with 12 weeks of induction followed by 40 weeks of maintenance At the end of 52 weeks in the MS period eligible participants from MS period will be offered a Double-Blind Maintenance Extension DBME period for up to 52 weeks
Additionally an Open Label OL period of up to 92 weeks will be offered to eligible participants The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks while the sum of the DBME and OL periods may not exceed 52 weeks depending on when participants switch
Detailed Description:
None
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