Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— CHANGE-MSOfficial title:
An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Verified date | January 2018 |
Source | GeNeuro SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS). This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.
Status | Completed |
Enrollment | 270 |
Est. completion date | December 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Main Inclusion Criteria: - For male or female with reproductive potential, use of reliable means of contraception; - RRMS according to the 2010 revised McDonald criteria; - Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months; - EDSS score < 6.0. Main Exclusion Criteria: - Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening; - Pregnant and nursing women. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GeNeuro SA | Institut de Recherches Internationales Servier, Les Laboratoires Servier (LLS), Worldwide Clinical Trials |
Bulgaria, Croatia, Czechia, Estonia, Germany, Hungary, Italy, Poland, Russian Federation, Serbia, Spain, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative number of Gd-enhancing T1 lesions in brain MRI | Week 12 to 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02861014 -
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
|
Phase 3 | |
Terminated |
NCT01435993 -
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
|
Phase 1 | |
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Completed |
NCT02410200 -
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
|
Phase 2 | |
Completed |
NCT03975413 -
Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
|
||
Completed |
NCT05080270 -
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
|
Early Phase 1 | |
Completed |
NCT01116427 -
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT01108887 -
An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmartâ„¢.
|
N/A | |
Completed |
NCT01141751 -
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
|
N/A | |
Completed |
NCT00097331 -
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT01909492 -
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
|
||
Completed |
NCT04121221 -
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
|
Phase 3 | |
Not yet recruiting |
NCT05290688 -
Cellular microRNA Signatures in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT04880577 -
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04528121 -
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT04002934 -
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
|
Phase 2 | |
Recruiting |
NCT05019248 -
Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
|
||
Completed |
NCT04580381 -
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
|
||
Completed |
NCT00071838 -
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 2 |