NCT03385564 is a Phase 2 clinical trial of BI 655064 in Lupus Nephritis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03385564?

NCT03385564 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03385564?

Interventions in NCT03385564: BI 655064, Placebo.

What condition does NCT03385564 study?

NCT03385564 studies Lupus Nephritis.

Is NCT03385564 still recruiting?

NCT03385564 is currently completed. Last updated 13 July 2022.

Are results published for NCT03385564?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-13 · How we verify

NCT03385564

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

Completed Phase 2 Results posted Last updated 13 July 2022

What this trial tests

Phase 2 trial testing BI 655064 in Lupus Nephritis in 69 participants. Completed in 27 July 2021.

Timeline

9 January 2018

Primary endpoint
25 May 2021

27 July 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	69
Start date	9 January 2018
Primary completion	25 May 2021
Estimated completion	27 July 2021
Sites	36 locations across Hong Kong, Japan, Greece, Malaysia, United Kingdom, Germany, Poland, Mexico

Drugs / interventions tested

BI 655064 — full drug profile →
Placebo

Conditions studied

Lupus Nephritis — all drugs for Lupus Nephritis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 70, any sex, with Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares Primary · 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 bas

Group	Value	95% CI
BI 655064 120 mg	51.83
BI 655064 180 mg	48.15
BI 655064 240 mg	59.49
Placebo	57.51

Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares Secondary · At Week 52

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).

Group	Value	95% CI
BI 655064 120 mg	42.9
BI 655064 180 mg	30.8
BI 655064 240 mg	50.0
Placebo	52.0

Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52 Secondary · 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.

Group	Value	95% CI
BI 655064 120 mg	57.1
BI 655064 180 mg	50.0
BI 655064 240 mg	60.0
Placebo	60.0

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 Secondary · At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated 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.

Group	Value	95% CI
BI 655064 120 mg	42.9
BI 655064 180 mg	42.9
BI 655064 240 mg	55.6
Placebo	39.1

Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks Secondary · At Week 52

The percentage of patients experiencing at least one renal flare during 52 weeks is reported.

Group	Value	95% CI
BI 655064 120 mg	0
BI 655064 180 mg	21.4
BI 655064 240 mg	0
Placebo	16.0

Time to First Renal Flare Over the Course of 52 Weeks Secondary · Up to 52 weeks.

The time to first renal flare over the course of 52 weeks is reported.

Group	Value	95% CI
BI 655064 180 mg	36.0	26 – 52
Placebo	37.5	6 – 52

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 Secondary · 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.

Group	Value	95% CI
BI 655064 120 mg	100.0
BI 655064 180 mg	64.3
BI 655064 240 mg	75.0
Placebo	68.0

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12 Secondary · At baseline and 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

Group	Value	95% CI
BI 655064 120 mg	-8.4	± 5.8
BI 655064 180 mg	-7.5	± 4.3
BI 655064 240 mg	-9.3	± 4.9
Placebo	-7.7	± 6.1

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26 Secondary · At baseline and 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

Group	Value	95% CI
BI 655064 120 mg	-8.7	± 5.7
BI 655064 180 mg	-7.9	± 3.5
BI 655064 240 mg	-11.3	± 4.8
Placebo	-5.9	± 5.2

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42 Secondary · At baseline and 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

Group	Value	95% CI
BI 655064 120 mg	-6.6	± 3.4
BI 655064 180 mg	-6.3	± 2.4
BI 655064 240 mg	-11.1	± 5.1
Placebo	-6.5	± 6.7

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52 Secondary · At baseline and 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

Group	Value	95% CI
BI 655064 120 mg	-8.9	± 6.1
BI 655064 180 mg	-7.2	± 4.0
BI 655064 240 mg	-10.6	± 4.9
Placebo	-5.3	± 8.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 655064 120 mg

Serious: 1/7 (14%)

Deaths: 0/7

BI 655064 180 mg

Serious: 2/15 (13%)

Deaths: 0/15

BI 655064 240 mg

Serious: 6/21 (29%)

Deaths: 1/21

Placebo

Serious: 4/26 (15%)

Deaths: 0/26

Serious adverse events (25 terms)

Reaction	System	BI 655064 120 mg	BI 655064 180 mg	BI 655064 240 mg	Placebo
Arrhythmia	Cardiac disorders	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—
Inappropriate antidiuretic hormone secretion	Endocrine disorders	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Haemobilia	Hepatobiliary disorders	—	—	—	—
Haemophagocytic lymphohistiocytosis	Immune system disorders	—	—	—	—
Clostridium difficile infection	Infections and infestations	—	—	—	—
Meningitis enterococcal	Infections and infestations	—	—	—	—
Nocardiosis	Infections and infestations	—	—	—	—
Pelvic abscess	Infections and infestations	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—
Tuberculosis of central nervous system	Infections and infestations	—	—	—	—
Femoral neck fracture	Injury, poisoning and procedural complications	—	—	—	—
Crystal arthropathy	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—	—	—
Ocular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Peripheral sensorimotor neuropathy	Nervous system disorders	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Panniculitis	Skin and subcutaneous tissue disorders	—	—	—	—

Other adverse events (62 terms — click to expand)

Reaction	System	BI 655064 120 mg	BI 655064 180 mg	BI 655064 240 mg	Placebo
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Urine protein/creatinine ratio increased	Investigations	—	—	—	—
Weight increased	Investigations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Lupus nephritis	Renal and urinary disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—
Cataract	Eye disorders	—	—	—	—
Photopsia	Eye disorders	—	—	—	—
Visual field defect	Eye disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Oedema	General disorders	—	—	—	—
Allergy to arthropod bite	Immune system disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Coronavirus infection	Infections and infestations	—	—	—	—
Herpes simplex	Infections and infestations	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Vaginal infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Arrhythmia, Adrenal insufficiency, Inappropriate antidiuretic hormone secretion, Ascites, Ileus, Nausea, Pyrexia, Haemobilia.

Data from ClinicalTrials.gov NCT03385564 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in the development of protein-protein interactions modulators: mechanisms and clinical trials.
Lu H, Zhou Q, He J, Jiang Z, et al · · 2020 · cited 570× · PMID 32968059 · DOI 10.1038/s41392-020-00315-3
Kinase inhibition in autoimmunity and inflammation.
Zarrin AA, Bao K, Lupardus P, Vucic D. · · 2021 · cited 302× · PMID 33077936 · DOI 10.1038/s41573-020-0082-8
Glomerulonephritis: immunopathogenesis and immunotherapy.
Anders HJ, Kitching AR, Leung N, Romagnani P. · · 2023 · cited 105× · PMID 36635359 · DOI 10.1038/s41577-022-00816-y
The past, present, and future of costimulation blockade in organ transplantation.
Schroder PM, Fitch ZW, Schmitz R, Choi AY, et al · · 2019 · cited 43× · PMID 31157670 · DOI 10.1097/mot.0000000000000656
Advances in Lupus Nephritis Pathogenesis: From Bench to Bedside.
Obrișcă B, Sorohan B, Tuță L, Ismail G. · · 2021 · cited 40× · PMID 33916456 · DOI 10.3390/ijms22073766
Novel Treatments in Lupus.
Vukelic M, Li Y, Kyttaris VC. · · 2018 · cited 32× · PMID 30524430 · DOI 10.3389/fimmu.2018.02658
Recent advances in immunotherapies for lupus nephritis.
Kaneko M, Jackson SW. · · 2023 · cited 17× · PMID 35778517 · DOI 10.1007/s00467-022-05670-7
Targeted therapies for lupus nephritis: Current perspectives and future directions.
Jia X, Lu Y, Zheng X, Tang R, et al · · 2024 · cited 8× · PMID 38057972 · DOI 10.1097/cm9.0000000000002959

Verify or expand the search:

Other trials of BI 655064

Trials testing the same drug.

NCT02331277 — Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers · Phase 1 · completed
NCT02009761 — Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thr · Phase 1 · terminated
NCT01917916 — Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers · Phase 1 · completed
NCT01751776 — Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of B · Phase 1 · completed

Other recruiting trials for Lupus Nephritis

Currently open trials in the same condition.

NCT07523542 — SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus · Phase 1, PHASE2 · recruiting
NCT07109986 — UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis · Phase 1 · recruiting
NCT07053891 — LUPKYNIS Drug-use Results Survey · recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
NCT06711887 — Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants · Phase 3 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03385564 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 13 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03385564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing