Lupus NephritisPhase 2NCT03385564
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
A Phase 2 study testing BI 655064 in people with Lupus Nephritis, run by Boehringer Ingelheim at 36 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- BI 655064
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 36 sitesin 16 countries
- Study dates
- 9 Jan 2018to 27 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients.
- Women of childbearing potential and men able to father a child must be ready and able to use two reliable methods of birth control simultaneously, one of which must be highly effective. Highly effective birth control per International Conference on Harmonisation (ICH) M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. The reliable methods of birth control must be used before starting Mycophenolate mofetil/Azathioprine (MMF/AZA) and the trial drug; then continue during the trial period; and for at least 50 days after the last dose of MMF/AZA and trial medication. In case a female patient is treated with AZA the contraception shall continue for 90 days after treatment with AZA.A list of contraception methods meeting these criteria is provided in the patient information.
- Sexually active men must be ready to use condoms during treatment with MMF/AZA and for at least 90 days after cessation of MMF/AZA.
- Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy.
- Tubal ligation is NOT a method of permanent sterilisation.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Show all 9Show fewer
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- 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.
Who cannot join
- Evidence of current or previous clinically significant diseases or medical conditions other than lupus, or findings of the medical examination (including vital signs and ECG) that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
- Significant central nervous system symptoms related to Systemic Lupus Erythematosus (SLE) based on investigators assessment.
- Clinically important acute or chronic infections including but not limited to HIV, hepatitis B or C.
- Impaired hepatic function defined as serum Aspartate Aminotransferase/Alanine Aminotransferase (AST/ALT), bilirubin or alkaline phosphatase > 2 x Upper Limit of Normal (ULN).
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening (using CKD-EPI formula).
- Known hypersensitivity to any constituents of the trial medication; and/or contraindications to Mycophenolate mofetil (MMF) or Azathioprine (AZA) or glucocorticoids.
Show all 10Show fewer
- The use of any restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Unable to comply with the protocol in the investigator's opinion.
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Trial locations and contacts
36 sites in 16 countries.
36 sites in 16 countries
United States4 sites
Northwell Health
Great Neck, New York, 11021
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324
Japan4 sites
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Okayama University Hospital
Okayama, Okayama, 700-8558
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Thailand4 sites
Siriraj Hospital
Bangkok, 10170
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Chiangmai University
Chiang Mai, 50200
Pramongkutklao Hospital
Rajathevee, 10400
Mexico3 sites
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14080
Poland3 sites
University Clinical Hospital in Bialystok I
Bialystok, 15-540
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
Radom, 26610
Czechia2 sites
General University Hospital
Prague, 12808
Institute of Rheumathology Prague
Prague, 12850
Germany2 sites
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376
Greece2 sites
University General Hospital Attikon
Athens, 124 62
University General Hospital of Heraklion
Heraklion, Crete, 71500
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, 999077
Queen Mary Hospital
Hong Kong, 999077
Philippines2 sites
Southern Philippines Medical Center
Davao City, 8000
Mary Mediatrix Medical Center
Lipa City, Batangas, 4217
Portugal2 sites
Hospital Curry Cabral, EPE
Lisbon, 1069-166
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-028
United Kingdom2 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Guy's Hospital
London, SE1 9RT
About this study
Official title: An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
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.
Read the detailed description
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
- Conditions
- Lupus Nephritis
- Being tested
- BI 655064, Placebo
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 655064Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BI 655064 |
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: BI 655064 |
| 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. Receives: Drug: BI 655064 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 52
Secondary outcomes (10)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At baseline and at Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start9 Jan 2018
- Primary completion25 May 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385564
- Sponsor's protocol ID
- 1293-0013
- Other IDs
- 2017-003101-17, 2017
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2017
- Last updated
- 13 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
- ClinicalTrials.gov ID
- NCT03385564
- Acronym / sponsor ID
- 1293-0013
- Conditions
- Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 655064 120 mg | Experimental | Drug: BI 655064120 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 | Drug: PlaceboMatching 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 | Drug: BI 655064180 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. |
| BI 655064 240 mg | Experimental | Drug: BI 655064120 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients.
- Women of childbearing potential and men able to father a child must be ready and able to use two reliable methods of birth control simultaneously, one of which must be highly effective. Highly effective birth control per International Conference on Harmonisation (ICH) M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. The reliable methods of birth control must be used before starting Mycophenolate mofetil/Azathioprine (MMF/AZA) and the trial drug; then continue during the trial period; and for at least 50 days after the last dose of MMF/AZA and trial medication. In case a female patient is treated with AZA the contraception shall continue for 90 days after treatment with AZA.A list of contraception methods meeting these criteria is provided in the patient information.
- Sexually active men must be ready to use condoms during treatment with MMF/AZA and for at least 90 days after cessation of MMF/AZA.
- Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy.
- Tubal ligation is NOT a method of permanent sterilisation.
Key exclusion criteria (10 listed)
- Evidence of current or previous clinically significant diseases or medical conditions other than lupus, or findings of the medical examination (including vital signs and ECG) that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
- Significant central nervous system symptoms related to Systemic Lupus Erythematosus (SLE) based on investigators assessment.
- Clinically important acute or chronic infections including but not limited to HIV, hepatitis B or C.
- Impaired hepatic function defined as serum Aspartate Aminotransferase/Alanine Aminotransferase (AST/ALT), bilirubin or alkaline phosphatase > 2 x Upper Limit of Normal (ULN).
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening (using CKD-EPI formula).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 655064subcutaneous injection | Drug | BI 655064 120 mg, BI 655064 180 mg, BI 655064 240 mg |
| Placebosubcutaneous injection | Drug | Placebo |
Primary outcome
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
Time frame: At Week 52
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.
10 secondary outcomes
Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares
Time frame: At Week 52
Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52
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
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
Time frame: At Week 52
Time to First Renal Flare Over the Course of 52 Weeks
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
Time frame: At Week 52
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12
Time frame: At baseline and at Week 12
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26
Time frame: At baseline and at Week 26
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42
Time frame: At baseline and at Week 42
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52
Time frame: At baseline and at Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 655064 in people with Lupus Nephritis, run by Boehringer Ingelheim at 36 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Japan, Thailand, Mexico, Poland and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.