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

NCT ID: NCT02770170

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2020-08-18

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.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 655064 dose 1

Group Type: EXPERIMENTAL

BI 655064 dose 1

Intervention Type: DRUG

BI 655064 dose 2

Group Type: EXPERIMENTAL

BI 655064 dose 2

Intervention Type: DRUG

BI 655064 dose 3

Group Type: EXPERIMENTAL

BI 655064 dose 3

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BI 655064 dose 1

Intervention Type: DRUG

BI 655064 dose 2

Intervention Type: DRUG

BI 655064 dose 3

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Academic Medical Research Institute

Los Angeles, California, United States

Integrity Clinical Research, LLC

Doral, Florida, United States

Hope Clinical Research

Kissimmee, Florida, United States

Integral Rheumatology and Immunology Specialist

Plantation, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwell Health

Great Neck, New York, United States

Feinstein Institute for Medical Research

Manhasset, New York, United States

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, United States

Office of Dr. Ramesh C. Gupta

Memphis, Tennessee, United States

The Prince of Wales Hospital

Randwick, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Toronto Western Hospital

Toronto, Ontario, Canada

CHU de Quebec-Universite Laval Research Centre

Québec, , Canada

Hospital Hradec Kralove

Hradec Králové, , Czechia

General University Hospital Prague 2, Nephrology Clinic

Prague, , Czechia

Institute of Rheumathology Prague

Prague, , Czechia

HOP Henri Mondor

Créteil, , France

HOP La Pitié Salpêtrière

Paris, , France

Universitätsklinikum Köln (AöR)

Cologne, , Germany

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Robert-Bosch-Krankenhaus GmbH

Stuttgart, , Germany

General Hospital of Athens "Laiko"

Athens, , Greece

University General Hospital Attikon

Athens, , Greece

University General Hospital of Heraklion

Heraklion, Crete, , Greece

Prince of Wales Hospital

Hong Kong, , Hong Kong

Queen Mary Hospital

Hong Kong, , Hong Kong

Azienda Ospedaliera Universitaria di Padova

Padua, , Italy

Hospital of the University of Occupational and Environmental Health

Fukuoka, Kitakyushu, , Japan

Hokkaido University Hospital

Hokkaido, Sapporo, , Japan

St. Marianna University School of Medicine Hospital

Kanagawa, Kawasaki, , Japan

Tohoku University Hospital

Miyagi, Sendai, , Japan

Okayama University Hospital

Okayama, Okayama, , Japan

Juntendo University Hospital

Tokyo, Bunkyo-ku, , Japan

Keio University Hospital

Tokyo, Shinjuku-ku, , Japan

Hospital Raja Permaisuri Bainun

Ipoh, , Malaysia

Hospital Tengku Ampuan Rahimah

Klang, , Malaysia

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, , Mexico

Instituto Nacional de Cs Médicas y Nutrición S Zubiran

Mexico City, , Mexico

H. Central Dr Ignacio M. P.

San Luis Potosí City, , Mexico

Angeles University Foundation Medical Center

Angeles City, , Philippines

Chong Hua Hospital

Cebu City, , Philippines

Cebu Doctors Hospital

Cebu City, Cebu, , Philippines

Southern Philippines Medical Center

Davao City, , Philippines

Mary Mediatrix Medical Center

Lipa City, Batangas, , Philippines

University Clinical Hospital in Bialystok I

Bialystok, , Poland

Norbert Barlicki University Clinical Hospital No.1, Lodz

Lodz, , Poland

Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard

Lodz, , Poland

Clinic Medical Center; Nowa Sol

Nowa Sól, , Poland

NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

Radom, , Poland

John Paul II Regional Hospital, Zamosc

Zamość, , Poland

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, , Portugal

Hospital Curry Cabral, EPE

Lisbon, , Portugal

CHULN, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Centro Hospitalar Universitário São João,EPE

Porto, , Portugal

Institute of Rheumatology, Belgrade

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Centre Nis

Niš, , Serbia

Ajou University Hospital

Suwon, , South Korea

Hospital Vall d'Hebron

Barcelona, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Dr. Peset

Valencia, , Spain

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Pramongkutklao Hospital

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Chiangmai University

Chiang Mai, , Thailand

Naresuan University Hospital

Muang, , Thailand

Addenbrooke's Hospital

Cambridge, , United Kingdom

Leicester General Hospital

Leicester, , United Kingdom

Guy's Hospital

London, , United Kingdom

Countries

United States; Australia; Canada; Czechia; France; Germany; Greece; Hong Kong; Italy; Japan; Malaysia; Mexico; Philippines; Poland; Portugal; Serbia; South Korea; Spain; Thailand; United Kingdom

References

Jayne DR, Steffgen J, Romero-Diaz J, Bajema I, Boumpas DT, Noppakun K, Amano H, Gomez HM, Satirapoj B, Avihingsanon Y, Chawanasuntorapoj R, Madero M, Naumnik B, Recto R, Fagan N, Revollo I, Wu J, Visvanathan S, Furie R. Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti-CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. Arthritis Rheumatol. 2023 Nov;75(11):1983-1993. doi: 10.1002/art.42557. Epub 2023 Aug 17.

Reference Type: DERIVED

PMID: 37192040 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2015-001750-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293.10

Identifier Type: -

Identifier Source: org_study_id