Clinical trial • Phase II • Immunology | Rare Disease
RILIPRUBART for Antibody-mediated rejection (AMR) | Transplant rejection
Phase II trial of RILIPRUBART for Antibody-mediated rejection (AMR) | Transplant rejection.
Overview
- Trial Therapeutic Area
- Immunology | Rare Disease
- Trial Disease
- Antibody-mediated rejection (AMR) | Transplant rejection
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 14-05-2024
- First CTIS Authorization Date
- 12-06-2024
Trial design
Randomised, open-label, soc (standard of care) arm as comparator; bivv020 + soc interventional arm. no specific bivv020 dosing schedule is provided in the available data (dose unit mg/kg; max total amount listed as 50 mg/kg; max treatment period listed as 49 with time unit code 2).-controlled, crossover Phase II trial across 14 sites in Sweden, Germany, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- SOC (standard of care) arm as comparator; BIVV020 + SOC interventional arm. No specific BIVV020 dosing schedule is provided in the available data (dose unit mg/kg; max total amount listed as 50 mg/kg; max treatment period listed as 49 with time unit code 2).
- Crossover
- Yes
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population flag is selected for the trial. Subject information and informed consent forms are provided for adult patients (multiple adult ICFs listed). ICFs and related materials are available in multiple languages (English, German, Spanish, French, Italian, Swedish). No specific information on assent or consent procedures for minors is provided in the available data..
- Vulnerable Population
- Vulnerable population flag is selected for the trial. Subject information and informed consent forms are provided for adult patients (multiple adult ICFs listed). ICFs and related materials are available in multiple languages (English, German, Spanish, French, Italian, Swedish). No specific information on assent or consent procedures for minors is provided in the available data.
Inclusion criteria
- {"criterion_text":"- Participant intended to receive SOC therapy per Investigator’s judgment and local practice. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor . Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR. BMI ≤ 40 kg/m2. Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).","number_of_inclusion_criteria":5}
Exclusion criteria
- {"criterion_text":"- Participants who are ABO incompatible with their donors.\n- Participants with known active ongoing infection as per below: a)\tPositive HIV. b)\tPositive HBV. c)\tHCV with detectable HCV RNA. d)\tWithin 4 weeks of first study intervention: any serious infection, or any active bacterial infection i, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention\n- History of active tuberculosis (TB) regardless of treatment.\n- Participants with clinical diagnosis of systemic lupus erythematosus (SLE).\n- Prior treatment with complement system inhibitor within 5 times the half-life.\n- Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cohort A: Treatment failure rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cohort B: AMR resolution rate","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Cohort A: Treatment failure rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cohort B: AMR resolution rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)","definition_or_measurement_approach":"Central laboratory assessment of eGFR calculated from serum creatinine using the MDRD equation (change from baseline)."}
- {"endpoint_text":"- Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio","definition_or_measurement_approach":"Central laboratory assessment of protein:creatinine ratio (change from baseline)."}
- {"endpoint_text":"- Change in allograft histopathology Banff score","definition_or_measurement_approach":"Change in allograft histopathology assessed using the Banff scoring criteria."}
- {"endpoint_text":"- Graft survival as predicted by iBOX","definition_or_measurement_approach":"Graft survival prediction evaluated using the iBOX prediction tool."}
- {"endpoint_text":"- Assessment of adverse events (AEs)","definition_or_measurement_approach":"Evaluation and recording of adverse events experienced by participants."}
- {"endpoint_text":"- Change in systemic lupus erythematosus (SLE) panel","definition_or_measurement_approach":"Change in SLE laboratory panel parameters from baseline."}
- {"endpoint_text":"- Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin","definition_or_measurement_approach":"Measurement of plasma exposure of BIVV020 with assessment of the pharmacokinetic parameter Cmin."}
- {"endpoint_text":"- Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC","definition_or_measurement_approach":"Measurement of plasma exposure of BIVV020 with assessment of the pharmacokinetic parameter AUC."}
- {"endpoint_text":"- Number of participants with anti-BIVV020 antibodies","definition_or_measurement_approach":"Determination and counting of participants who develop anti-BIVV020 antibodies."}
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 53
- Consent Approach
- Informed consent is obtained from adult participants. Subject information and informed consent forms are provided for adult patients and are available in multiple languages (English, German, Spanish, French, Italian, Swedish). Documents include pre-screening and partner/pregnancy information forms. No information on assent procedures for minors is provided.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 40
Sweden
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 13
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Transplantationsmottagningen
- Principal Investigator Name
- Tomas Lorant
- Principal Investigator Email
- tomas.lorant@surgsci.uu.se
- Contact Person Name
- Tomas Lorant
- Contact Person Email
- tomas.lorant@surgsci.uu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Transplantationsmottagningen
- Principal Investigator Name
- Lars Wennberg
- Principal Investigator Email
- lars.wennberg@regionstockholm.se
- Contact Person Name
- Lars Wennberg
- Contact Person Email
- lars.wennberg@regionstockholm.se
Germany
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 14-06-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Nephrologie/Intensivmedizin
- Principal Investigator Name
- Fabian Halleck
- Principal Investigator Email
- fabian.halleck@charite.de
- Contact Person Name
- Fabian Halleck
- Contact Person Email
- fabian.halleck@charite.de
Spain
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 13
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Nefrología
- Principal Investigator Name
- Amado Andres Belmonte
- Principal Investigator Email
- amado.andres@salud.madrid.org
- Contact Person Name
- Amado Andres Belmonte
- Contact Person Email
- amado.andres@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Nefrología
- Principal Investigator Name
- Oriol BESTARD MATAMOROS
- Principal Investigator Email
- oriol.bestard@vallhebron.cat
- Contact Person Name
- Oriol BESTARD MATAMOROS
- Contact Person Email
- oriol.bestard@vallhebron.cat
France
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 18
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service de Nephrologie-Transplantation-Dialyse-Aphérèses
- Principal Investigator Name
- Pierre Merville
- Principal Investigator Email
- pierre.merville@chu-bordeaux.fr
- Contact Person Name
- Pierre Merville
- Contact Person Email
- pierre.merville@chu-bordeaux.fr
- Site Name
- Hospital Foch
- Department Name
- Service de Nephrologie Dialyse et Transplantation Rénale
- Principal Investigator Name
- Alexandre Hertig
- Principal Investigator Email
- a.hertig@hopital-foch.com
- Contact Person Name
- Alexandre Hertig
- Contact Person Email
- a.hertig@hopital-foch.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Néphrologie-Transplantations
- Principal Investigator Name
- Carmen Lefaucher
- Principal Investigator Email
- carmen.lefaucheur@aphp.fr
- Contact Person Name
- Carmen Lefaucher
- Contact Person Email
- carmen.lefaucheur@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Nephrologie et Transplantation
- Principal Investigator Name
- Nassim Kamar
- Principal Investigator Email
- kamar.n@chu-toulouse.fr
- Contact Person Name
- Nassim Kamar
- Contact Person Email
- kamar.n@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- Service de Nephrologie et Transplantation
- Principal Investigator Name
- Philippe Grimbert
- Principal Investigator Email
- philippe.grimbert@aphp.fr
- Contact Person Name
- Philippe Grimbert
- Contact Person Email
- philippe.grimbert@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Unita Operativa di Nefrologia
- Principal Investigator Name
- Nicola Bossini
- Principal Investigator Email
- bossini-nicola@libero.it
- Contact Person Name
- Nicola Bossini
- Contact Person Email
- bossini-nicola@libero.it
- Site Name
- Azienda Ospedaliera Ospedale Niguarda Ca Granda
- Department Name
- Struttura Complessa Nefrologia
- Principal Investigator Name
- Enrico Minetti
- Principal Investigator Email
- enrico.minetti@ospedaleniguarda.it
- Contact Person Name
- Enrico Minetti
- Contact Person Email
- enrico.minetti@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS
- Department Name
- Unita di Nefrologia, Dialisi e Trapianto di Rene - PAD 15
- Principal Investigator Name
- Gaetano La Mann
- Principal Investigator Email
- gaetano.lamanna@unibo.it
- Contact Person Name
- Gaetano La Mann
- Contact Person Email
- gaetano.lamanna@unibo.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unita Operativa Complessa Nefrologia
- Principal Investigator Name
- Giuseppe Grandaliano
- Principal Investigator Email
- giuseppe.grandaliano@policlinicogemelli.it
- Contact Person Name
- Giuseppe Grandaliano
- Contact Person Email
- giuseppe.grandaliano@policlinicogemelli.it
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: [4]
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties codes: [4]
- Name
- Endpoint Clinical Inc.
- Responsibilities
- sponsorDuties codes: [3]
- Name
- Cognizant Technology Solutions India Private Limited
- Responsibilities
- sponsorDuties codes: [6]
Third parties
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: Central Medical Reading or Imaging Reading","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Cognizant Technology Solutions India Private Limited","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"sponsorDuties codes: [15]; value: Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Northwestern University","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Educational Institution"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- riliprubart
- Active Substance
- RILIPRUBART
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 50 mg/kg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- TIBULIZUMAB for Systemic sclerosis | Systemic sclerosis-associated interstitial lung disease
- IMEROPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- tabelecleucel for Epstein-Barr virus-associated primary immunodeficiency lymphoproliferative disease (PID LPD) | Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (PTLD) | Epstein-Barr virus-associated sarcoma (including leiomyosarcoma) | Epstein-Barr virus-associated CNS post-transplant lymphoproliferative disorder
- Secukinumab for Takayasu arteritis
- SARILUMAB for Systemic juvenile idiopathic arthritis | Juvenile idiopathic arthritis