CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Mycophenolate Mofetil/Mycophenolic Acid +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02550652
NCT02550652Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

Hoffmann-La Roche·interventional·Posted Sep 15, 2015·Updated Aug 27, 2024

In Brief

A Phase 2 clinical trial evaluating Mycophenolate Mofetil/Mycophenolic Acid, Obinutuzumab, and 3 other interventions for Lupus Nephritis. Completed, enrolled 126 participants across 46 sites in 12 countries.

Detailed Summary

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesArgentina, Brazil, Colombia, Costa Rica, France, Israel, Italy, Mexico, Panama, Peru, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartNov 13, 2015
Primary CompletionJan 15, 2019
Study CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.8 years ago

Interventions

Mycophenolate Mofetil/Mycophenolic Aciddrug

MMF/MPA will be administered as per schedule specified in the respective arm.

Obinutuzumabdrug

Obinutuzumab will be administered as per schedule specified in the respective arm.

Placeboother

Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.

Methylprednisolonedrug

Methylprednisolone IV will be administered as per schedule specified in the respective arm.

Prednisonedrug

Prednisone will be administered as per schedule specified in the respective arm.