Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02321709
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2014-12-05
Brief Title:
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study Of Safety Tolerability And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patients
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Primary Objective
To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 Q4 weeks repeated ascending subcutaneous doses of SAR113244
Secondary Objectives
To assess in male and female lupus patients
The pharmacokinetics of SAR113244
The pharmacodynamics of SAR113244 for the following disease-related parameters
Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index SELENA-SLEDAI score British Isles Lupus Assessment Group BILAG score if applicable BILAG-Based Composite Lupus Assessment BICLA if applicable systemic lupus erythematosus responder index SRI if applicable Lupus-quality of life QoL and Functional Assessment of Chronic Illness Therapy FACIT-Fatigue anti-double stranded deoxyribonucleic acid antibody anti-dsDNA Ab and anti-nuclear antibody levels ANA and plasma complement levels C3 C4 erythrocyte sedimentation SED rate and C-reactive protein
Peripheral blood B and T cells subsets
To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 Q4 weeks repeated ascending subcutaneous doses of SAR113244
Secondary Objectives
To assess in male and female lupus patients
The pharmacokinetics of SAR113244
The pharmacodynamics of SAR113244 for the following disease-related parameters
Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index SELENA-SLEDAI score British Isles Lupus Assessment Group BILAG score if applicable BILAG-Based Composite Lupus Assessment BICLA if applicable systemic lupus erythematosus responder index SRI if applicable Lupus-quality of life QoL and Functional Assessment of Chronic Illness Therapy FACIT-Fatigue anti-double stranded deoxyribonucleic acid antibody anti-dsDNA Ab and anti-nuclear antibody levels ANA and plasma complement levels C3 C4 erythrocyte sedimentation SED rate and C-reactive protein
Peripheral blood B and T cells subsets
Detailed Description:
The total duration of screening to end of study per subject is 20 weeks with post-study observation on Day 226 for anti-drug antibody assessment for patients with positive anti-drug antibody at end of study only
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 |
|---|---|---|---|
| U1111-1154-6184 | OTHER | UTN | None |
| 2014-001690-13 | EUDRACT_NUMBER | None | None |