Clinical trial NCT03385564: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Official title: An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-12-28
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares
timeFrame: At Week 52
measure: Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52
timeFrame: At Week 52
measure: Percentage of Patients With Complete Renal Response (CRR) at Week 52 and Sustained Steroid Reduction to ≤5 Milligrams (mg)/Day (d) From Week 26 to Week 52
timeFrame: At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52).
measure: Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks
timeFrame: At Week 52
measure: Time to First Renal Flare Over the Course of 52 Weeks
timeFrame: Up to 52 weeks.
measure: Percentage of Patients With Partial Renal Response (PRR) and Without Any Renal Flares Derived From Urine Protein (UP) 24 Hours (h) Collection at Week 52
timeFrame: At Week 52
measure: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12
timeFrame: At baseline and at Week 12
measure: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26
timeFrame: At baseline and at Week 26
measure: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42
timeFrame: At baseline and at Week 42
measure: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52
timeFrame: At baseline and at Week 52
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Integral Rheumatology and Immunology Specialist
state: Florida
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval Research Centre
city: Prague
country: Czechia
facility: General University Hospital
city: Prague
country: Czechia
facility: Institute of Rheumathology Prague
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Heraklion, Crete
country: Greece
facility: University General Hospital of Heraklion
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Okayama, Okayama
country: Japan
facility: Okayama University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Klang
country: Malaysia
facility: Hospital Tengku Ampuan Rahimah
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cs Médicas y Nutrición S Zubiran
city: Davao
country: Philippines
facility: Southern Philippines Medical Center
city: Lipa City, Batangas
country: Philippines
facility: Mary Mediatrix Medical Center
city: Bialystok
country: Poland
facility: University Clinical Hospital in Bialystok I
city: Lodz
country: Poland
facility: Norbert Barlicki University Clinical Hospital No.1, Lodz
city: Radom
country: Poland
facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
city: Lisboa
country: Portugal
facility: Hospital Curry Cabral, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Chiangmai
country: Thailand
facility: Chiangmai University
city: Rajathevee
country: Thailand
facility: Pramongkutklao Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
References: