Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02770170
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: BI 655064 dose 1 Drug: BI 655064 dose 2 Drug: BI 655064 dose 3 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 655064 dose 1 Drug: BI 655064 dose 1
Experimental: BI 655064 dose 2 Drug: BI 655064 dose 2
Experimental: BI 655064 dose 3 Drug: BI 655064 dose 3
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Proportion of patients with complete renal response [ Time Frame: week 52 ]

Secondary Outcome Measures :
  1. Proportion of patients with complete renal response [ Time Frame: week 26 ]
  2. Proportion of patients with partial renal response [ Time Frame: week 26 and 52 ]
  3. Proportion of patients with major renal response [ Time Frame: week 26 and 52 ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
  • Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
  • Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
  • Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]
  • Signed and dated written informed consent

Exclusion criteria:

  • Clinically significant current other renal disease
  • Glomerular Filtration Rate <30ml/min/1.73m²
  • Dialysis within 12m of screening
  • Antiphospholipid syndrome
  • Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
  • Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
  • Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation

    • Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
    • Treatment with abatacept within 12 months prior to randomisation
    • Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
    • Treatment with cyclophosphamid within 6 months prior to randomisation
    • Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
  • Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
  • Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
  • Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
  • Live vaccination within 6 weeks before randomisation
  • Patients unable to comply with the protocol in the investigator's opinion.
  • Alcohol abuse in the opinion of the investigator or active drug abuse .
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal
  • Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02770170

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

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United States, California
Saint Jude Heritage Recruiting
Fullerton, California, United States, 92835
Academic Medical Research Institute Recruiting
Los Angeles, California, United States, 90022
United States, Florida
Integrity Clinical Research, LLC Terminated
Doral, Florida, United States, 33166
Hope Clinical Research Recruiting
Kissimmee, Florida, United States, 34741
Integral Rheumatology and Immunology Specialist Recruiting
Plantation, Florida, United States, 33324
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Columbia University Medical Center-New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
United States, Tennessee
Office of Dr. Ramesh C. Gupta Recruiting
Memphis, Tennessee, United States, 38119
Australia, New South Wales
The Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
LKH-Univ. Hospital Graz Recruiting
Graz, Austria, 8036
Hospital Hietzing Recruiting
Wien, Austria, 1130
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
CHU de Quebec-Universite Laval Research Centre Recruiting
Quebec, Canada, G1V 4G2
Hospital Hradec Kralove Recruiting
Hradec Kralove, Czechia, 50005
General University Hospital Prague 2, Nephrology Clinic Recruiting
Prague, Czechia, 12808
Institute of Rheumathology Prague Recruiting
Prague, Czechia, 12850
HOP Henri Mondor Recruiting
Creteil, France, 94010
HOP Européen Recruiting
Marseille, France, 13003
HOP La Pitié Salpêtrière Recruiting
Paris, France, 75013
HOP Européen G. Pompidou Recruiting
Paris, France, 75908
HOP Civil Recruiting
Strasbourg cedex, France, 37091
HOP Rangueil Recruiting
Toulouse, France, 31400
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Universitätsmedizin Göttingen, Georg-August-Universität Recruiting
Göttingen, Germany, 37075
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Universitätsklinikum Köln (AöR) Recruiting
Köln, Germany, 50937
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany, 23538
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Robert-Bosch-Krankenhaus GmbH Recruiting
Stuttgart, Germany, 70376
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
General Hospital of Athens "Laiko" Recruiting
Athens, Greece, 115 27
University General Hospital Attikon Recruiting
Athens, Greece, 124 62
Gen.Univ.Hosp. of Heraklion Recruiting
Heraklion, Crete, Greece, 711 10
Hong Kong
Prince of Wales Hospital Recruiting
HK, Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Azienda Ospedaliera Universitaria di Padova Recruiting
Padova, Italy, 35128
A.O. San Camillo Forlanini Recruiting
Roma, Italy, 00152
Azienda Universitaria-Universita' La Sapienza Recruiting
Roma, Italy, 00161
Ospedale Mauriziano di Torino Recruiting
Torino, Italy, 10128
University Hospital of Occupational and Environmental Health Recruiting
Fukuoka, Kitakyushu, Japan, 807-8556
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Recruiting
Hiroshima, Hiroshima, Japan, 730-8619
Hokkaido University Hospital Recruiting
Hokkaido, Sapporo, Japan, 060-8648
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Kawasaki, Japan, 216-8511
Tohoku University Hospital Recruiting
Miyagi, Sendai, Japan, 980-8574
Nagasaki University Hospital Recruiting
Nagasaki, Nagasaki, Japan, 852-8501
Okayama University Hospital Recruiting
Okayama, Okayama, Japan, 700-8558
Juntendo University Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8431
Keio University Hospital Recruiting
Tokyo, Shinjuku-ku, Japan, 160-8582
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-380
Hospital Raja Permaisuri Bainun Recruiting
Ipoh, Malaysia, 30990
Hospital Tengku Ampuan Rahimah Recruiting
Klang, Malaysia, 41200
Hospital Cardiologica Aguascalientes Recruiting
Aguascalientes, Mexico, 20230
Instituto Nacional de Cardiologia Ignacio Chavez Recruiting
Ciudad de Mexico, Mexico, 14080
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubiran" Recruiting
Ciudad de Mexico, Mexico, 14080
H. Central Dr Ignacio M. P. Recruiting
San Luis Potosi, Mexico, 78240
Angeles University Foundation Medical Center Recruiting
Angeles City, Philippines, 2009
Cebu Doctors Hospital Recruiting
Cebu City, Cebu, Philippines
Chong Hua Hospital Recruiting
Cebu City, Philippines, 6000
Southern Philippines Medical Center Recruiting
Davao, Philippines, 8000
Mary Mediatrix Medical Center Recruiting
Lipa City, Batangas, Philippines, 4217
University Clinical Hospital in Bialystok I Recruiting
Bialystok, Poland, 15-540
Norbert Barlicki University Clinical Hospital No.1, Lodz Recruiting
Lodz, Poland, 90-153
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard Terminated
Lodz, Poland, 92-213
Clinic Medical Center; Nowa Sol Recruiting
Nowa Sol, Poland, 67-100
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom Recruiting
Radom, Poland, 26610
Military Medical Institute Central Clinical Hospital of Ministry of Defence, Department of Internal Medicine, Nephrology and Dialysis Recruiting
Warsaw, Poland, 04-141
John Paul II Regional Hospital, Zamosc Recruiting
Zamosc, Poland, 22-400
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Recruiting
Coimbra, Portugal, 3000-075
Hospital Curry Cabral, EPE Recruiting
Lisboa, Portugal, 1069-166
CHLN, EPE - Hospital de Santa Maria Recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar São João,EPE Recruiting
Porto, Portugal, 4200-319
Clinical Center of Serbia Recruiting
Belgrade, Serbia, 11000
Military Medical Academy Recruiting
Belgrade, Serbia, 11000
Clinical Centre Nis Recruiting
Nis, Serbia, 18000
Clinical Center of Vojvodina Recruiting
Novi Sad, Serbia, 21000
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Dr. Peset Recruiting
Valencia, Spain, 46017
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Pramongkutklao Hospital Recruiting
Bangkok, Thailand, 10400
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Chiangmai University Recruiting
Chiangmai, Thailand, 50200
Naresuan University Hospital Recruiting
Muang, Thailand, 65000
Istanbul Universitesi Cerrahpasa Tip Fakultesi Recruiting
Istanbul, Turkey, 34098
Dokuz Eylul Universitesi Ic Hastaliklari Anabilim Dali Recruiting
Izmir, Turkey, 35340
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Leicester General Hospital Recruiting
Leicester, United Kingdom, LE5 4PW
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT02770170     History of Changes
Other Study ID Numbers: 1293.10
2015-001750-15 ( EudraCT Number )
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases