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NCT02550652 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT02550652: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT02550652 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02550652, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by \< 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio \< 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of cen
Interventions
- DRUG Obinutuzumab
- OTHER Placebo
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG Mycophenolate Mofetil/Mycophenolic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2015-11-13 |
| Est. Completion | 2023-08-02 |
| Phase | Phase 2 |
What the finished NCT02550652 record still lists
NCT02550652 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT02550652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02550652 about?
NCT02550652 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)". 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.
What is the current status of trial NCT02550652?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2015-11-13. Estimated completion is 2023-08-02.
What interventions are being tested in trial NCT02550652?
The interventions under investigation include: Obinutuzumab (DRUG), Placebo (OTHER), Prednisone (DRUG), Methylprednisolone (DRUG), Mycophenolate Mofetil/Mycophenolic Acid (DRUG).
Who is sponsoring clinical trial NCT02550652?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02550652's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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