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

NCT ID: NCT03385564

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2021-07-27

Brief Summary

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.

Detailed Description

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

Conditions

Lupus Nephritis

Study Design

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

Study Groups

BI 655064 120 mg

120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

Group Type: EXPERIMENTAL

BI 655064

Intervention Type: DRUG

subcutaneous injection

Placebo

Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

subcutaneous injection

BI 655064 180 mg

180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

Group Type: EXPERIMENTAL

BI 655064

Intervention Type: DRUG

subcutaneous injection

BI 655064 240 mg

120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

Group Type: EXPERIMENTAL

BI 655064

Intervention Type: DRUG

subcutaneous injection

Interventions

BI 655064

subcutaneous injection

Intervention Type: DRUG

Placebo

subcutaneous injection

Intervention Type: DRUG

Eligibility 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.

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.

• 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

Locations

Integral Rheumatology and Immunology Specialist

Plantation, Florida, 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

Princess Alexandra Hospital

Woolloongabba, , Australia

CHU de Quebec-Universite Laval Research Centre

Québec, , Canada

General University Hospital

Prague, , Czechia

Institute of Rheumathology Prague

Prague, , Czechia

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Robert-Bosch-Krankenhaus GmbH

Stuttgart, , Germany

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

Hokkaido University Hospital

Hokkaido, Sapporo, , Japan

Tohoku University Hospital

Miyagi, Sendai, , Japan

Okayama University Hospital

Okayama, Okayama, , Japan

Juntendo University Hospital

Tokyo, Bunkyo-ku, , Japan

Hospital Tengku Ampuan Rahimah

Klang, , Malaysia

Centenario Hospital Miguel Hidalgo

Aguascalientes, , Mexico

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, , Mexico

Instituto Nacional de Cs Médicas y Nutrición S Zubiran

Mexico City, , Mexico

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

NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

Radom, , Poland

Hospital Curry Cabral, EPE

Lisbon, , Portugal

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

Lisbon, , Portugal

Ajou University Hospital

Suwon, , South Korea

Siriraj Hospital

Bangkok, , Thailand

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Chiangmai University

Chiang Mai, , Thailand

Pramongkutklao Hospital

Rajathevee, , Thailand

Addenbrooke's Hospital

Cambridge, , United Kingdom

Guy's Hospital

London, , United Kingdom

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2017-003101-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293-0013

Identifier Type: -

Identifier Source: org_study_id