A Phase 2 interventional study of BI 655064 and Placebo in Lupus Nephritis, sponsored by Boehringer Ingelheim. Completed at 36 sites in 16 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
Initially planned participating countries:
Argentina, Australia, Canada, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Malaysia, Mexico, Philippines, Poland, Portugal, Serbia, Spain, Taiwan, Thailand, United Kingdom, United States
338 studies on the registry are indexed under Lupus Nephritis; 131 are open to participants now.
This study's enrollment of 69 is above the median of 48 across 237 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Group 1 patients only:
- Achieved either a Complete renal Response (CRR) or a Partial Renal Response (PRR) or proteinuria ≤ 1g/d (or UP/UC ≤ 1) at the end of 1293.10.
Exclusion Criteria:
120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Drug: BI 655064
Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Drug: Placebo
180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Drug: BI 655064
120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Drug: BI 655064
subcutaneous injection
subcutaneous injection
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with complete renal response (CRR) and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.
Time frame: At Week 52
Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares
The percentage of patients with confirmed complete renal response (CRR) (defined as CRR at both Week 42 and Week 52 using urine protein (UP)/urine creatine (UC) ratio \[UP/UC\] from the spot urines) and without any renal flares is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
Time frame: At Week 52
Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52
The percentage of patients with proteinuria \<0.8 grams (g)/day (d) and without any renal flares at week 52 is reported.
Time frame: At Week 52
Percentage of Patients With Complete Renal Response (CRR) at Week 52 and Sustained Steroid Reduction to ≤5 Milligrams (mg)/Day (d) From Week 26 to Week 52
The percentage of patients with complete renal response (CRR) at Week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52 is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.
Time frame: At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52).
Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks
The percentage of patients experiencing at least one renal flare during 52 weeks is reported.
Time frame: At Week 52
Time to First Renal Flare Over the Course of 52 Weeks
The time to first renal flare over the course of 52 weeks is reported.
Time frame: Up to 52 weeks.
Percentage of Patients With Partial Renal Response (PRR) and Without Any Renal Flares Derived From Urine Protein (UP) 24 Hours (h) Collection at Week 52
The percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52 is reported. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
Time frame: At Week 52
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 12 is reported. Change from baseline at Week 12 is calculated as: value at Week 12 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
Time frame: At baseline and at Week 12
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 26 is reported. Change from baseline at Week 26 is calculated as: value at Week 26 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
Time frame: At baseline and at Week 26
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 42 is reported. Change from baseline at Week 42 is calculated as: value at Week 42 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
Time frame: At baseline and at Week 42
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 52 is reported. Change from baseline at Week 52 is calculated as: value at Week 52 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
Time frame: At baseline and at Week 52
This study was to evaluate long-term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to standard of care during maintenance treatment for lupus nephritis.
| Milestone | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Started | 7 | 15 | 21 | 26 |
| Intent to treat set | 7 | 15 | 21 | 26 |
| Completed | 7 | 14 | 16 | 17 |
| Not completed | 0 | 1 | 5 | 9 |
| Withdrew: Adverse event | 0 | 0 | 3 | 3 |
| Withdrew: Other than listed | 0 | 0 | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 1 | 0 |
The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with complete renal response (CRR) and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares | 51.83 | 48.15 | 59.49 | 57.51 |
The percentage of patients with confirmed complete renal response (CRR) (defined as CRR at both Week 42 and Week 52 using urine protein (UP)/urine creatine (UC) ratio \[UP/UC\] from the spot urines) and without any renal flares is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares | 42.9 | 30.8 | 50.0 | 52.0 |
The percentage of patients with proteinuria \<0.8 grams (g)/day (d) and without any renal flares at week 52 is reported.
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52 | 57.1 | 50.0 | 60.0 | 60.0 |
The percentage of patients with complete renal response (CRR) at Week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52 is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients With Complete Renal Response (CRR) at Week 52 and Sustained Steroid Reduction to ≤5 Milligrams (mg)/Day (d) From Week 26 to Week 52 | 42.9 | 42.9 | 55.6 | 39.1 |
The percentage of patients experiencing at least one renal flare during 52 weeks is reported.
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks | 0 | 21.4 | 0 | 16.0 |
The time to first renal flare over the course of 52 weeks is reported.
| Weeks | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Time to First Renal Flare Over the Course of 52 Weeks | — | 36.0 (26 to 52) | — | 37.5 (6 to 52) |
The percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52 is reported. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
| Percentage of participants | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Percentage of Patients With Partial Renal Response (PRR) and Without Any Renal Flares Derived From Urine Protein (UP) 24 Hours (h) Collection at Week 52 | 100.0 | 64.3 | 75.0 | 68.0 |
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 12 is reported. Change from baseline at Week 12 is calculated as: value at Week 12 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
| Score on a scale | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12 | -8.4 ± 5.8 | -7.5 ± 4.3 | -9.3 ± 4.9 | -7.7 ± 6.1 |
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 26 is reported. Change from baseline at Week 26 is calculated as: value at Week 26 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
| Score on a scale | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26 | -8.7 ± 5.7 | -7.9 ± 3.5 | -11.3 ± 4.8 | -5.9 ± 5.2 |
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 42 is reported. Change from baseline at Week 42 is calculated as: value at Week 42 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
| Score on a scale | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42 | -6.6 ± 3.4 | -6.3 ± 2.4 | -11.1 ± 5.1 | -6.5 ± 6.7 |
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 52 is reported. Change from baseline at Week 52 is calculated as: value at Week 52 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).
| Score on a scale | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52 | -8.9 ± 6.1 | -7.2 ± 4.0 | -10.6 ± 4.9 | -5.3 ± 8.0 |
Collected over For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BI 655064 120 mg | 0/7 (0%) | 1/7 (14.3%) | 6/7 (85.7%) |
| BI 655064 180 mg | 0/15 (0%) | 2/15 (13.3%) | 11/15 (73.3%) |
| BI 655064 240 mg | 1/21 (4.8%) | 6/21 (28.6%) | 15/21 (71.4%) |
| Placebo | 0/26 (0%) | 4/26 (15.4%) | 15/26 (57.7%) |
| Event | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| ArrhythmiaCardiac disorders | 1/7 | 0/15 | 0/21 | 0/26 |
| Pyelonephritis acuteInfections and infestations | 0/7 | 1/15 | 0/21 | 0/26 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/7 | 1/15 | 0/21 | 0/26 |
| Adrenal insufficiencyEndocrine disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| Inappropriate antidiuretic hormone secretionEndocrine disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| AscitesGastrointestinal disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| IleusGastrointestinal disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| NauseaGastrointestinal disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| PyrexiaGeneral disorders | 0/7 | 0/15 | 1/21 | 0/26 |
| Clostridium difficile infectionInfections and infestations | 0/7 | 0/15 | 1/21 | 0/26 |
| Event | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/7 | 3/15 | 5/21 | 3/26 |
| DiarrhoeaGastrointestinal disorders | 1/7 | 3/15 | 1/21 | 2/26 |
| RashSkin and subcutaneous tissue disorders | 0/7 | 0/15 | 4/21 | 2/26 |
| Ear painEar and labyrinth disorders | 1/7 | 0/15 | 0/21 | 0/26 |
| VertigoEar and labyrinth disorders | 1/7 | 0/15 | 0/21 | 1/26 |
| CataractEye disorders | 1/7 | 0/15 | 0/21 | 0/26 |
| PhotopsiaEye disorders | 1/7 | 0/15 | 0/21 | 0/26 |
| Visual field defectEye disorders | 1/7 | 0/15 | 0/21 | 0/26 |
| Abdominal painGastrointestinal disorders | 1/7 | 0/15 | 1/21 | 0/26 |
| NauseaGastrointestinal disorders | 1/7 | 0/15 | 1/21 | 0/26 |
Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
| Age, Continuous(Years) | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 31.9 ± 6.5 | 36.5 ± 8.7 | 35.4 ± 10.5 | 34.8 ± 10.9 | 35.1 ± 9.9 |
| Sex: Female, Male(Participants) | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 5 | 13 | 19 | 24 | 61 |
| Male | 2 | 2 | 2 | 2 | 8 |
| Ethnicity (NIH/OMB)(Participants) | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 6 | 6 | 19 |
| Not Hispanic or Latino | 4 | 11 | 15 | 20 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 6 | 9 | 11 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 3 | 9 | 11 | 15 | 38 |
| More than one race | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Data sharing details ↗ · www.mystudywindow.com
Ran from Jan 2018 to primary completion in May 2021, 40 months.
Results were first posted in Jul 2022, 1 year 1 month after primary completion.
Of 31 phase 2 interventional studies under Lupus Nephritis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 57. This study's 40 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BI 655064