Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01900431
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2013-07-11
Brief Title:
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious Intermediate Posterior or Pan-Uveitis NIU
Status:
COMPLETED
Status Verified Date:
2017-05
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:
SARILNIUSATURN
Brief Summary:
Primary Objective
To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis NIU
Secondary Objectives
To evaluate the change in best corrected visual acuity BCVA To evaluate the safety of subcutaneous sarilumab in participants with NIU To evaluate the change in macular edema To evaluate the change in other signs of ocular inflammation To evaluate the effect on retinal vessel leakage To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy
To evaluate the change in ocular inflammation in the anterior chamber To evaluate the pharmacokinetics of sarilumab in NIU participants To evaluate the immunogenicity with anti-drug antibodies ADA
To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis NIU
Secondary Objectives
To evaluate the change in best corrected visual acuity BCVA To evaluate the safety of subcutaneous sarilumab in participants with NIU To evaluate the change in macular edema To evaluate the change in other signs of ocular inflammation To evaluate the effect on retinal vessel leakage To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy
To evaluate the change in ocular inflammation in the anterior chamber To evaluate the pharmacokinetics of sarilumab in NIU participants To evaluate the immunogenicity with anti-drug antibodies ADA
Detailed Description:
The total duration per participant was up to 58 weeks which included a 2 week screening period 16 weeks principal treatment period Part A 34 weeks extension treatment period Part B or open label treatment period Part C and 6 weeks after last treatment administration
Participants with decrease in vitreous haze VH 2 or corticosteroids dose 10 mgday at Week 16 were considered as responders Participants who did not complete the principal treatment period Part A due to lack of efficacy or no decrease in VH 2 and corticosteroids dose 10 mgday at Week 16 or no decrease in VH 2 and corticosteroids dose missing at Week 16 or non-responder according to medical review were considered as non-responders
Responder participants observed at Week 16 at the end of Part A were invited to continue in the extension treatment period Part B
Non-responder participants observed within the first 16 weeks were offered to be treated by open-label sarilumab Part C
Participants with decrease in vitreous haze VH 2 or corticosteroids dose 10 mgday at Week 16 were considered as responders Participants who did not complete the principal treatment period Part A due to lack of efficacy or no decrease in VH 2 and corticosteroids dose 10 mgday at Week 16 or no decrease in VH 2 and corticosteroids dose missing at Week 16 or non-responder according to medical review were considered as non-responders
Responder participants observed at Week 16 at the end of Part A were invited to continue in the extension treatment period Part B
Non-responder participants observed within the first 16 weeks were offered to be treated by open-label sarilumab Part C
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-004845-34 | None | None | None |
| U1111-1130-6500 | OTHER | UTN | None |