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NCT01499355 · ClinicalTrials.gov registry record · Phase 2
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 276
- Enrollment target
NCT01499355: Clinical Trial Phase 2 study, sponsored by Biogen.
NCT01499355 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 276 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499355, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 276 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
Primary Outcome
Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) \< 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of \< 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR \< 3.0 mg/
Interventions
- BIOLOGICAL Placebo
- DRUG mycophenolate mofetil
- DRUG oral corticosteroids
- BIOLOGICAL BIIB023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Why NCT01499355 stopped before completion
NCT01499355 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01499355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499355 about?
NCT01499355 is a clinical study titled "BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis". The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to...
What is the current status of trial NCT01499355?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2012-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01499355?
The interventions under investigation include: Placebo (BIOLOGICAL), mycophenolate mofetil (DRUG), oral corticosteroids (DRUG), BIIB023 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01499355?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01499355's enrollment target sits among peer trials
276 202nd of 2000 higher than 1,798 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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