Systemic Lupus Erythematosus Clinical Trial
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 Patient
Primary Objective:
Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell
subsets compared to placebo.
Secondary Objectives:
Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability
and safety of SAR113244.
Assess in male and female lupus patients:
- The pharmacokinetics of SAR113244.
- The pharmacodynamics of SAR113244 for the following disease 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
(if applicable), Lupus-quality of life and Functional Assessment of Chronic
Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and
anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte
sedimentation rate and C-reactive protein.
- Peripheral blood B and T cell subsets.
The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only). ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03843125 -
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
|
Phase 3 | |
| Recruiting |
NCT05698173 -
Systemic Lupus Erythematosus and Accelerated Aging
|
N/A | |
| Active, not recruiting |
NCT01649765 -
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
|
Phase 2 | |
| Recruiting |
NCT05704153 -
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
|
N/A | |
| Completed |
NCT05048238 -
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
|
Phase 1 | |
| Recruiting |
NCT06056778 -
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
|
||
| Completed |
NCT04358302 -
Individual Patient Exposure and Response in Pediatric Lupus
|
N/A | |
| Completed |
NCT03802578 -
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
|
N/A | |
| Completed |
NCT02554019 -
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT04835883 -
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
|
Phase 2 | |
| Terminated |
NCT02665364 -
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00278538 -
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
| Completed |
NCT03252587 -
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
|
Phase 2 | |
| Terminated |
NCT02066311 -
Nelfinavir in Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT01892748 -
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
|
N/A | |
| Terminated |
NCT01689025 -
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
| Completed |
NCT01475149 -
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
|
N/A | |
| Unknown status |
NCT01712529 -
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
|
N/A | |
| Completed |
NCT00962832 -
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
|
Phase 2 |