Participant flow

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis · Source last updated 2026-07-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received obinutuzumab, 1000 milligrams (mg) as an intravenous (IV) infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with mycophenolate mofetil (MMF) and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and every 6 months (Q6M) thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.

   id

   FG000

   title

   Obinutuzumab

2. description

   Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance with Study Drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      type

      Reason not Specified

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   9. reasons

      1. group Id

         FG000

         num Subjects

         116

      2. group Id

         FG001

         num Subjects

         102

      type

      Ongoing in the Study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         135

      2. group Id

         FG001

         num Subjects

         136

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         136

      2. group Id

         FG001

         num Subjects

         132

      comment

      Safety evaluable population included all participants who received any part of blinded infusion of Obinutuzumab/placebo \& are grouped according to treatment they received. 3 participants from placebo arm were excluded from the safety analysis as they received no treatment post-randomization. 1 participant randomized to the placebo arm received obinutuzumab \& was included in the obinutuzumab arm for safety analysis.

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         122

      2. group Id

         FG001

         num Subjects

         120

      type

      Completed Week 76 Assessment

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         135

      2. group Id

         FG001

         num Subjects

         136

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in a 1:1 ratio to Obinutuzumab/placebo. As pre-specified in the statistical analysis plan (SAP), participant flow data for all participants randomized to 1 of the 2 dosing schedules of obinutuzumab (Groups 1 \& 2) were reported in the combined obinutuzumab treatment group. This study is ongoing.

recruitment Details

A total of 271 participants with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN) treated with standard-of-care (SOC) therapy took part in the study across 72 sites in 15 countries. This study consists of blinded treatment with obinutuzumab or placebo, followed by open-label treatment (OLT) with obinutuzumab.

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Preserved source evidence · Not medical advice