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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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.
For Group 2 patients only:
  • - Age 18 -70 years at screening.
For patients in Japan, age 20
  • - 70 years at screening.
  • - Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997 with at least 4 criteria documented, one of which must either be a positive Antinuclear Antibody (ANA) or a positive anti-double strand DeoxyriboNucleic Acid (dsDNA) antibody at the time of starting induction therapy (historical data).
  • - Lupus Nephritis Class III or IV (co-existing class V permitted) based on International Society of Nephrology / Renal Pathology Society (ISN/RPS) 2003 classification with either active or active/chronic disease, proven by renal biopsy before the start of induction therapy (historical data).
  • - Achieved either a CRR or a PRR or proteinuria ≤ 1.5g/d (or UP/UC ≤ 1.5) after at least 6 months of induction treatment (either with Standard of Care (SOC) (Cyclophosphamide (CYC) or MMF-based) or SOC in combination with other available therapies used for induction treatment of Lupus Nephritis (LN) e.g. tacrolimus, cyclosporin, experimental drug etc.); and within 12 months after initiating induction therapy outside of 1293.10 trial.
  • - Steroid dose ≤ 15 mg/d prednisone-equivalent at baseline.

Exclusion Criteria:

  • - 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.
  • - 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.
For Group 2 patients only:
  • - Clinically significant current non-SLE related renal diseases based on investigator's judgment (e.g. post-infectious glomerulonephritis, pyelonephritis, interstitial nephritis, glomerulosclerosis).
  • - Dialysis within 12 months of screening.
  • - Live vaccination within 6 weeks prior to randomisation.
  • - Antiphospholipid syndrome defined as positive antiphospholipid antibodies and either history of any thrombotic event or history of miscarriage.
  • - Diabetes mellitus if poorly controlled or accompanied by known diabetic retinopathy or diabetic nephropathy.
It is in the investigator's judgment if the diabetes is sufficiently controlled for the patient to enter the trial.
  • - With regard to previous induction treatments, the following applies: -- Treatment with tacrolimus or cyclosporine or mizoribine within 1 month prior to randomisation.
  • - Treatment with belimumab or other "BLyS antagonists" or another investigational drug within 3 months or 5 half-lives, whichever is greater, prior to randomisation.
  • - Treatment with abatacept or cyclophosphamide within 3 months prior to randomisation.
  • - Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20) within 6 months prior to randomisation.
  • - Are not eligible according to the following tuberculosis (TB) screening criteria: - Have signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist).
  • - Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen according to local guidelines within the past 3 years and at least 6 months prior to the first administration of study drug.
  • - Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or during screening, in which latent or active TB has not been ruled out, except for patients with history of TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study drug.
  • - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • - Previous enrolment in 1293.10 and did not complete the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03385564
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Czechia, Germany, Greece, Hong Kong, Japan, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Portugal, Spain, Thailand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis
Additional Details

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

Arms & Interventions

Arms

Experimental: BI 655064

Placebo Comparator: Placebo

Interventions

Drug: - BI 655064

subcutaneous injection

Drug: - Placebo

subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Plantation, Florida

Status

Recruiting

Address

Integral Rheumatology and Immunology Specialist

Plantation, Florida, 33324

Site Contact

Guillermo Valenzuela

drvalenzuela@aol.com

+001 (954) 476-2338

Northwell Health, Great Neck, New York

Status

Recruiting

Address

Northwell Health

Great Neck, New York, 11021

Site Contact

Sonali Narain

snarain@northwell.edu

+001 (516) 708-2550

Feinstein Institute for Medical Research, Manhasset, New York

Status

Recruiting

Address

Feinstein Institute for Medical Research

Manhasset, New York, 11030

Site Contact

Cynthia Aranow

caranow@northwell.edu

+001 (516) 562-3837

New York, New York

Status

Recruiting

Address

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032

Site Contact

Laura Geraldino-Pardilla

lbg2124@cumc.columbia.edu

+001 (212) 342-1587

International Sites

Princess Alexandra Hospital, Woolloongabba, Australia

Status

Completed

Address

Princess Alexandra Hospital

Woolloongabba, , 4102

Quebec, Canada

Status

Completed

Address

CHU de Quebec-Universite Laval Research Centre

Quebec, , G1V 4G2

Prague, Czechia

Status

Active, not recruiting

Address

General University Hospital Prague 2, Nephrology Clinic

Prague, , 12808

Institute of Rheumathology Prague, Prague, Czechia

Status

Active, not recruiting

Address

Institute of Rheumathology Prague

Prague, , 12850

Mainz, Germany

Status

Recruiting

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Site Contact

Andreas Schwarting

schwarting@uni-mainz.de

+49 (6131) 177128

Robert-Bosch-Krankenhaus GmbH, Stuttgart, Germany

Status

Recruiting

Address

Robert-Bosch-Krankenhaus GmbH

Stuttgart, , 70376

Site Contact

Mark Dominik Alscher

Dominik.Alscher@rbk.de

4971181013496

University General Hospital Attikon, Athens, Greece

Status

Recruiting

Address

University General Hospital Attikon

Athens, , 124 62

Site Contact

Dimitrios Boumpas

boumpasd@med.uoc.gr

2105831990 / 1935

University General Hospital of Heraklion, Heraklion, Crete, Greece

Status

Recruiting

Address

University General Hospital of Heraklion

Heraklion, Crete, , 711 10

Site Contact

Prodromos Sidiropoulos

sidiropp@med.uoc.gr

+302810394783

Prince of Wales Hospital, Hong Kong, Hong Kong

Status

Recruiting

Address

Prince of Wales Hospital

Hong Kong, ,

Site Contact

Lai-Shan Tam

lstam@cuhk.edu.hk

852 3505 1429

Queen Mary Hospital, Hong Kong, Hong Kong

Status

Recruiting

Address

Queen Mary Hospital

Hong Kong, ,

Site Contact

Daniel Tak Mao Chan

dtmchan@hku.hk

852 2255 5977

Hokkaido University Hospital, Hokkaido, Sapporo, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Hokkaido, Sapporo, , 060-8648

Site Contact

Tatsuya Atsumi

at.hokudai01@gmail.com

+81 11 7161161

Tohoku University Hospital, Miyagi, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Miyagi, Sendai, , 980-8574

Site Contact

Tomonori Ishii

tishii@med.tohoku.ac.jp

022-717-7000

Okayama University Hospital, Okayama, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, Okayama, , 700-8558

Site Contact

Yoshinori Matsumoto

ymatsumoto@okayama-u.ac.jp

+81 86 2237151

Juntendo University Hospital, Tokyo, Bunkyo-ku, Japan

Status

Recruiting

Address

Juntendo University Hospital

Tokyo, Bunkyo-ku, , 113-8431

Site Contact

Hirofumi Amano

amano@juntendo.ac.jp

03-3813-3111

Ajou University Hospital, Suwon, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital

Suwon, , 16499

Site Contact

Chang-Hee Suh

chsuh@ajou.ac.kr

82 31 219 5118

Hospital Tengku Ampuan Rahimah, Klang, Malaysia

Status

Recruiting

Address

Hospital Tengku Ampuan Rahimah

Klang, , 41200

Site Contact

Norleen Zulkarnain Sim

oleen@me.com

60123023089

Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico

Status

Recruiting

Address

Centenario Hospital Miguel Hidalgo

Aguascalientes, , 20259

Site Contact

Alfredo Chew Wong

acheww@yahoo.com

(449) 915 4000 Ext. 330

Ciudad de Mexico, Mexico

Status

Recruiting

Address

Instituto Nacional de Cardiologia Ignacio Chavez

Ciudad de Mexico, , 14080

Site Contact

Magdalena Madero Rovalo

madero.magdalena@gmail.com

55 73 29 11 Ext.1264

Ciudad de Mexico, Mexico

Status

Recruiting

Address

Instituto Nacional de Cs Médicas y Nutrición S Zubiran

Ciudad de Mexico, , 14080

Site Contact

Juanita Romero Díaz

juanita.romerodiaz@gmail.com

+52 5487 0900 Ext. 2604

Southern Philippines Medical Center, Davao, Philippines

Status

Recruiting

Address

Southern Philippines Medical Center

Davao, , 8000

Site Contact

Edgar Ramiterre

ebramiterre@mac.com

63822214950

Mary Mediatrix Medical Center, Lipa City, Batangas, Philippines

Status

Recruiting

Address

Mary Mediatrix Medical Center

Lipa City, Batangas, , 4217

Site Contact

Rhona Recto

rhona_recto@yahoo.com

+63437403016

Bialystok, Poland

Status

Recruiting

Address

University Clinical Hospital in Bialystok I

Bialystok, , 15-540

Site Contact

Beata Naumnik

bnaumnik@poczta.onet.pl

+48857409458

Lodz, Poland

Status

Recruiting

Address

Norbert Barlicki University Clinical Hospital No.1, Lodz

Lodz, , 90-153

Site Contact

Ilona Kurnatowska

kuril@wp.pl

00485 09293095

Clinic Medical Center; Nowa Sol, Nowa Sol, Poland

Status

Recruiting

Address

Clinic Medical Center; Nowa Sol

Nowa Sol, , 67-100

Site Contact

Malgorzata Miakisz

miakisz@twojaprzychodnia.com

0048684177519

Radom, Poland

Status

Recruiting

Address

NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

Radom, , 26610

Site Contact

Antoni Sokalski

ant.sokalski@wp.pl

+48 361 5140

Hospital Curry Cabral, EPE, Lisboa, Portugal

Status

Recruiting

Address

Hospital Curry Cabral, EPE

Lisboa, , 1069-166

Site Contact

Fernando Nolasco

fnolasco@netcabo.pt

351217924200

CHULN, EPE - Hospital de Santa Maria, Lisboa, Portugal

Status

Recruiting

Address

CHULN, EPE - Hospital de Santa Maria

Lisboa, , 1649-028

Site Contact

Nikita Khmelinskii

nkhmelinskii@gmail.com

+35 21 780 5000

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Site Contact

Manuel Praga

mpragat@senefro.org

+34913908383

Siriraj Hospital, Bangkok, Thailand

Status

Recruiting

Address

Siriraj Hospital

Bangkok, , 10170

Site Contact

Ratana Chawanasuntorapoj

ratana99@googlemail.com

+662-419-8383

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

Status

Recruiting

Address

King Chulalongkorn Memorial Hospital

Bangkok, , 10330

Site Contact

Yingyos Avihingsanon

yingyos.a@gmail.com

+662-256-4251

Chiangmai University, Chiangmai, Thailand

Status

Recruiting

Address

Chiangmai University

Chiangmai, , 50200

Site Contact

Kajohnsak Noppakun

kajohnsak.noppakun@cmu.ac.th

+6653- 934-451

Pramongkutklao Hospital, Rajathevee, Thailand

Status

Recruiting

Address

Pramongkutklao Hospital

Rajathevee, , 10400

Site Contact

Bancha Satirapoj

satirapoj@yahoo.com

+66 2 3547600 ext 94296

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, , CB2 0QQ

Site Contact

David Jayne

dj106@cam.ac.uk

01223 254674

Guy's Hospital, London, United Kingdom

Status

Recruiting

Address

Guy's Hospital

London, , SE1 9RT

Site Contact

David D'Cruz

david.d'cruz@kcl.ac.uk

02071 889 756