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New drug shows promise for lupus kidney patients

NCT ID NCT02770170

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three doses of a drug called BI 655064 in 121 people with active lupus nephritis, a kidney complication of lupus. The goal was to see if the drug, given as a shot under the skin, could improve kidney function after one year when added to standard treatments. The trial compared the drug to a placebo to find the best dose for future larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 655064
What this could lead to
If successful, this could point toward a new add-on treatment option for lupus nephritis, potentially improving kidney outcomes.
What could go wrong
This is an early phase 2 trial with only 121 participants. The drug may not show clear benefit over placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

121 people

The number who actually took part.

Started

May 2016

Finished

Aug 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

Contacts and locations

Locations

  • Academic Medical Research Institute

    Los Angeles, California, 90022, United States

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Angeles University Foundation Medical Center

    Angeles City, 2009, Philippines

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • CHU de Quebec-Universite Laval Research Centre

    Québec, G1V 4G2, Canada

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075, Portugal

  • CHULN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Cebu Doctors Hospital

    Cebu City, Cebu, 6000, Philippines

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

    Lodz, 92-213, Poland

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4200-319, Portugal

  • Chiangmai University

    Chiang Mai, 50200, Thailand

  • Chong Hua Hospital

    Cebu City, 6000, Philippines

  • Clinic Medical Center; Nowa Sol

    Nowa Sól, 67-100, Poland

  • Clinical Centre Nis

    Niš, 18000, Serbia

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Feinstein Institute for Medical Research

    Manhasset, New York, 11030, United States

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • General Hospital of Athens "Laiko"

    Athens, 115 27, Greece

  • General University Hospital Prague 2, Nephrology Clinic

    Prague, 12808, Czechia

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • H. Central Dr Ignacio M. P.

    San Luis Potosí City, 78240, Mexico

  • HOP Henri Mondor

    Créteil, 94010, France

  • HOP La Pitié Salpêtrière

    Paris, 75013, France

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648, Japan

  • Hope Clinical Research

    Kissimmee, Florida, 34741, United States

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230, Mexico

  • Hospital Curry Cabral, EPE

    Lisbon, 1069-166, Portugal

  • Hospital Dr. Peset

    Valencia, 46017, Spain

  • Hospital Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990, Malaysia

  • Hospital Tengku Ampuan Rahimah

    Klang, 41200, Malaysia

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556, Japan

  • Institute of Rheumathology Prague

    Prague, 12850, Czechia

  • Institute of Rheumatology, Belgrade

    Belgrade, 11000, Serbia

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico City, 14080, Mexico

  • Instituto Nacional de Cs Médicas y Nutrición S Zubiran

    Mexico City, 14080, Mexico

  • Integral Rheumatology and Immunology Specialist

    Plantation, Florida, 33324, United States

  • Integrity Clinical Research, LLC

    Doral, Florida, 33166, United States

  • John Paul II Regional Hospital, Zamosc

    Zamość, 22-400, Poland

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431, Japan

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582, Japan

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Leicester General Hospital

    Leicester, LE5 4PW, United Kingdom

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217, Philippines

  • Military Medical Academy

    Belgrade, 11000, Serbia

  • NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

    Radom, 26610, Poland

  • Naresuan University Hospital

    Muang, 65000, Thailand

  • Norbert Barlicki University Clinical Hospital No.1, Lodz

    Lodz, 90-153, Poland

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Office of Dr. Ramesh C. Gupta

    Memphis, Tennessee, 38119, United States

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Pramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Prince of Wales Hospital

    Hong Kong, 999077, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376, Germany

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Southern Philippines Medical Center

    Davao City, 8000, Philippines

  • St. Marianna University School of Medicine Hospital

    Kanagawa, Kawasaki, 216-8511, Japan

  • The Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • University Clinical Hospital in Bialystok I

    Bialystok, 15-540, Poland

  • University General Hospital Attikon

    Athens, 124 62, Greece

  • University General Hospital of Heraklion

    Heraklion, Crete, 711 10, Greece

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538, Germany

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.