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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003101-17 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655064 120 mg | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| BI 655064 180 mg | Experimental | 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. |
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| BI 655064 240 mg | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 655064 | Drug | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integral Rheumatology and Immunology Specialist | Plantation | Florida | 33324 | United States | ||
| Northwell Health |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'.
This is an extension trial with the requirement to entry that subjects responded to treatment in 1293.10 (NCT02770170) and had the desire to continue participation in a clinical trial. Subjects were screened for eligibility prior to participation in trial 1293.10 (NCT02770170).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 655064 120 mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2020 | Jun 21, 2022 |
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|
| Placebo | Drug | subcutaneous injection |
|
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | At baseline and at Week 52 |
| Great Neck |
| New York |
| 11021 |
| United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| CHU de Quebec-Universite Laval Research Centre | Québec | G1V 4G2 | Canada |
| General University Hospital | Prague | 12808 | Czechia |
| Institute of Rheumathology Prague | Prague | 12850 | Czechia |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Robert-Bosch-Krankenhaus GmbH | Stuttgart | 70376 | Germany |
| University General Hospital Attikon | Athens | 124 62 | Greece |
| University General Hospital of Heraklion | Heraklion, Crete | 71500 | Greece |
| Prince of Wales Hospital | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Hokkaido University Hospital | Hokkaido, Sapporo | 060-8648 | Japan |
| Tohoku University Hospital | Miyagi, Sendai | 980-8574 | Japan |
| Okayama University Hospital | Okayama, Okayama | 700-8558 | Japan |
| Juntendo University Hospital | Tokyo, Bunkyo-ku | 113-8431 | Japan |
| Hospital Tengku Ampuan Rahimah | Klang | 41200 | Malaysia |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20259 | Mexico |
| Instituto Nacional de Cardiologia Ignacio Chavez | Mexico City | 14080 | Mexico |
| Instituto Nacional de Cs Médicas y Nutrición S Zubiran | Mexico City | 14080 | Mexico |
| Southern Philippines Medical Center | Davao City | 8000 | Philippines |
| Mary Mediatrix Medical Center | Lipa City, Batangas | 4217 | Philippines |
| University Clinical Hospital in Bialystok I | Bialystok | 15-540 | Poland |
| Norbert Barlicki University Clinical Hospital No.1, Lodz | Lodz | 90-153 | Poland |
| NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom | Radom | 26610 | Poland |
| Hospital Curry Cabral, EPE | Lisbon | 1069-166 | Portugal |
| Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria | Lisbon | 1649-028 | Portugal |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Siriraj Hospital | Bangkok | 10170 | Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Chiangmai University | Chiang Mai | 50200 | Thailand |
| Pramongkutklao Hospital | Rajathevee | 10400 | Thailand |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| FG001 | BI 655064 180 mg | 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. |
| FG002 | BI 655064 240 mg | 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. |
| FG003 | Placebo | 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. |
| Intent to Treat Set |
|
| COMPLETED | Completed trial medication |
|
| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 655064 120 mg | 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. |
| BG001 | BI 655064 180 mg | 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. |
| BG002 | BI 655064 240 mg | 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. |
| BG003 | Placebo | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 |
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| Secondary | 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). | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 |
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| Secondary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 |
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| Secondary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52). |
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| Secondary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 |
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| Secondary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subject with non-missing results were included in the analysis. | Posted | Median | Full Range | Weeks | Up to 52 weeks. |
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| Secondary | 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. | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Number | Percentage of participants | At Week 52 |
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| Secondary | 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). | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 12 |
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| Secondary | 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). | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 26 |
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| Secondary | 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). | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 42 |
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| Secondary | 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). | Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 52 |
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 655064 120 mg | 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. | 0 | 7 | 1 | 7 | 6 | 7 |
| EG001 | BI 655064 180 mg | 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. | 0 | 15 | 2 | 15 | 11 | 15 |
| EG002 | BI 655064 240 mg | 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. | 1 | 21 | 6 | 21 | 15 | 21 |
| EG003 | Placebo | 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. | 0 | 26 | 4 | 26 | 15 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Meningitis enterococcal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tuberculosis of central nervous system | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Crystal arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ocular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Chillblains | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oligoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Subacute cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.
BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2021 | May 11, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627991 | BI 655064 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Regression, Logistic | 0.5811 | Difference | -9.37 | 2-Sided | 80 | -31.178 | 12.440 | The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method. | Other | Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included 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. |
| Regression, Logistic | 0.8972 | Difference | 1.97 | 2-Sided | 80 | -17.534 | 21.480 | The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method. | Other | Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included 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. |
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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| BI 655064 180 mg |
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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
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.
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| OG001 | BI 655064 180 mg | 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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
| OG001 | BI 655064 180 mg | 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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
| OG001 | BI 655064 180 mg | 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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|
| OG001 | BI 655064 180 mg | 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. |
| OG002 | BI 655064 240 mg | 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. |
| OG003 | Placebo | 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. |
|
|