Trial · NCT01930890
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
NCT01930890, 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 Long-Term Extension Study in Subjects With Lupus Nephritis. Trials, record NCT01930890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01930890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
- NCT number
- NCT01930890
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Lupus Nephritis
- Interventions
- BIIB023, mycophenolate mofetil, oral corticosteroids
- First posted
- 2013-08-29
- Last updated
- 2017-01-18
- Other registries' IDs
- eudract:2013-000594-69
- Results first posted
- 2017-01-18
- Limitations and caveats
Study was terminated based on the pre-specified, blinded futility analysis of Study 211LE201 (NCT01499355), which did not demonstrate sufficient efficacy to warrant continuation of the studies. Study was not terminated based on safety considerations.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 108 | AEs with a start date on or after the first dose date in study 211LE202. 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 subject 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 subject or may require intervention to prevent one of the other outcomes listed above. |
| Primary | Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE | Up to Week 108 | AEs with a start date on or after the first dose date in study 211LE202. 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 subject 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 subject or may require intervention to prevent one of the other outcomes listed above. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 108 | The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202). | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE | Up to Week 108 | The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Any event | 4 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | Any event | 23 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Any event | 7 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Any event | 19 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Moderate or severe event | 2 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | Moderate or severe event | 12 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Moderate or severe event | 3 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Moderate or severe event | 6 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Severe event | 0 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | Severe event | 4 | participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 14 | |
| Overall Study | STARTED | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 33 | |
| Overall Study | STARTED | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | 13 | |
| Overall Study | STARTED | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | 27 | |
| Overall Study | COMPLETED | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | |
| Overall Study | COMPLETED | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | |
| Overall Study | COMPLETED | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | 0 | |
| Overall Study | COMPLETED | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | 0 | |
| Overall Study | NOT COMPLETED | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 14 | |
| Overall Study | NOT COMPLETED | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events308
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 | Vertigo | Ear and labyrinth disorders | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | 14 | |
| other | Vertigo | Ear and labyrinth disorders | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | 33 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | 1 | 13 | |
| other | Vertigo | Ear and labyrinth disorders | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | 0 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 1 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | 2 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | 1 | 27 | |
| other | Constipation | Gastrointestinal disorders | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | 14 | |
| other | Constipation | Gastrointestinal disorders | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 0 | 33 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | ||
| Total, all-cause mortality | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | ||
| Total, all-cause mortality | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | ||
| Total, all-cause mortality | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | ||
| Total, other adverse events | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 4 | 14 |
| Total, other adverse events | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 19 | 33 |
| Total, other adverse events | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | 7 | 13 |
| Total, other adverse events | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | 13 | 27 |
| Total, serious adverse events | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | 1 | 14 |
| Total, serious adverse events | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | 7 | 33 |
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/NCT01930890
GET https://conductscience.org/api/trials/v1/NCT01930890/results?page=2