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

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ClinicalTrials.gov Identifier: NCT02770170
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : October 2, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 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 25, 2019
Estimated Study Completion Date : August 25, 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02770170


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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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: October 2, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases