Trial · NCT01499355
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
NCT01499355, Phase 2, Terminated, Biogen; results first posted 2017-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis. Trials, record NCT01499355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01499355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
- NCT number
- NCT01499355
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 276 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Lupus Nephritis
- Interventions
- BIIB023, Placebo, mycophenolate mofetil, oral corticosteroids
- First posted
- 2011-12-26
- Last updated
- 2017-01-18
- Other registries' IDs
- eudract:2011-002159-32
- Results first posted
- 2017-01-18
- Limitations and caveats
Study was terminated based on the review of results following the prespecified, blinded futility analysis, which did not demonstrate sufficient efficacy to warrant continuation of the study. Study was not terminated based on safety considerations.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 | Week 52 | 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/mg if the Day 1 (Baseline) ratio was \> 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 \[Baseline\] or serum creatinine within normal range). |
| Secondary | Percentage of Participants Who Achieve Complete Renal Response at Week 52 | Week 52 | Complete renal response is defined as uPCR \< 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range. |
| Secondary | Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | Week 52 | Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR \<0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. |
| Secondary | Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52 | Baseline to Week 52 | Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR \<0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) 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/mg if the Day 1 (Baseline) ratio was \> 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 \[Baseline\] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve. |
| Secondary | Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52 | Baseline (Day 1), Week 52 | |
| Secondary | Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52 | Baseline, Week 52 | Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): \> 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and \> 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: \< 5 RBC/HPF and \< 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts). |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period | Day 1 to Week 12 | AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. |
| Secondary | Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period | Week 12 to Week 56 | AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. |
| Secondary | Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study | up to Week 52 | Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR \<0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) 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/mg if the Day 1 (Baseline) ratio was \> 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 \[Baseline\] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 | Week 52 | Participants in the modified intent-to-treat (mITT) population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Complete Renal Response at Week 52 | Week 52 | Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.) | percentage of participants | NUMBER |
| SECONDARY | Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | Week 52 | Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52 | Baseline to Week 52 | Participants in the ITT population who achieved a renal response at Week 52. The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo). | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52 | Baseline (Day 1), Week 52 | Participants with a uPCR \> 3.0 mg/mg at Baseline in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes those who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52 | Baseline, Week 52 | Participants with active urinary sediment at Day 1 in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.) | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period | Day 1 to Week 12 | All enrolled participants | participants | NUMBER |
| SECONDARY | Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period | Week 12 to Week 56 | The safety population was defined as all subjects who received at least 1 dose of study treatment (including placebo or BIIB023). | participants | NUMBER |
| SECONDARY | Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study | up to Week 52 | The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo). | days | MEAN |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 | Placebo | 25 | 90% Confidence Interval 14.7 to 35.3 | percentage of participants | |
| Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 | BIIB023 3 mg/kg | 16 | 90% Confidence Interval 7.6 to 25.0 | percentage of participants | |
| Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52 | BIIB023 20 mg/kg | 31 | 90% Confidence Interval 20.3 to 42.3 | percentage of participants | |
| Percentage of Participants Who Achieve Complete Renal Response at Week 52 | Placebo | 6 | percentage of participants | ||
| Percentage of Participants Who Achieve Complete Renal Response at Week 52 | BIIB023 3 mg/kg | 8 | percentage of participants | ||
| Percentage of Participants Who Achieve Complete Renal Response at Week 52 | BIIB023 20 mg/kg | 8 | percentage of participants | ||
| Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | Placebo | 1-day duration | 2 | Participants | |
| Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | BIIB023 3 mg/kg | 1-day duration | 3 | Participants | |
| Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | BIIB023 20 mg/kg | 1-day duration | 2 | Participants | |
| Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52 | Placebo | 27-day duration | 0 | Participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Period | STARTED | Run-In Period: All Enrolled Participants | 276 | |
| Run-In Period | STARTED | Double-Blind Period: Placebo | 0 | |
| Run-In Period | STARTED | Double-Blind Period: BIIB023 3 mg/kg | 0 | |
| Run-In Period | STARTED | Double-Blind Period: BIIB023 20 mg/kg | 0 | |
| Run-In Period | COMPLETED | Run-In Period: All Enrolled Participants | 245 | |
| Run-In Period | COMPLETED | Double-Blind Period: Placebo | 0 | |
| Run-In Period | COMPLETED | Double-Blind Period: BIIB023 3 mg/kg | 0 | |
| Run-In Period | COMPLETED | Double-Blind Period: BIIB023 20 mg/kg | 0 | |
| Run-In Period | NOT COMPLETED | Run-In Period: All Enrolled Participants | 31 | |
| Run-In Period | NOT COMPLETED | Double-Blind Period: Placebo | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Run-in Period | 7 | 276 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 4 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | BIIB023 3 mg/kg | 4 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | BIIB023 20 mg/kg | 7 | 62 | |
| other | Leukopenia | Blood and lymphatic system disorders | Run-in Period | 10 | 276 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 7 | 63 | |
| other | Leukopenia | Blood and lymphatic system disorders | BIIB023 3 mg/kg | 5 | 63 | |
| other | Leukopenia | Blood and lymphatic system disorders | BIIB023 20 mg/kg | 2 | 62 | |
| other | Neutropenia | Blood and lymphatic system disorders | Run-in Period | 3 | 276 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 4 | 63 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | BIIB023 3 mg/kg | ||
| Total, all-cause mortality | BIIB023 20 mg/kg | ||
| Total, other adverse events | Run-in Period | 134 | 276 |
| Total, other adverse events | Placebo | 33 | 63 |
| Total, other adverse events | BIIB023 3 mg/kg | 46 | 63 |
| Total, other adverse events | BIIB023 20 mg/kg | 43 | 62 |
| Total, serious adverse events | Run-in Period | 28 | 276 |
| Total, serious adverse events | Placebo | 7 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01499355
GET https://conductscience.org/api/trials/v1/NCT01499355/results?page=2