Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06867094
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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 Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2025-12
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:
SPECIFI-UC
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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants.
* The study duration will be up to 59 weeks.
* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants.
* The study duration will be up to 59 weeks.
* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
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?:
None
Is an FDA AA801 Violation?: