Clinical trial • Phase II • Immunology
EFGARTIGIMOD ALFA for Antibody-mediated rejection
Phase II trial of EFGARTIGIMOD ALFA for Antibody-mediated rejection.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Antibody-mediated rejection
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 27-06-2024
- First CTIS Authorization Date
- 14-10-2024
Trial design
Randomised, placebo ph20 sc – prefilled syringe (placebo to efgartigimod ph20 sc – prefilled syringe) (placebo comparator; dose/schedule not specified in available data)-controlled Phase II trial in Austria, Belgium, Czechia and others.
- Randomised
- Yes
- Comparator
- Placebo PH20 SC – prefilled syringe (placebo to Efgartigimod PH20 SC – prefilled syringe) (placebo comparator; dose/schedule not specified in available data)
- Target Sample Size
- 25
Eligibility
Recruits 25 Vulnerable population selected. Caregiver-specific subject information and informed consent form documents (ICF_Caregiver) are provided in the submission (country-specific ICF/Caregiver documents available), indicating consent considerations for caregivers; adults provide consent via the provided SIS and ICF documents..
- Pregnancy Exclusion
- Pregnant or lactating state or intention to become pregnant during the study
- Vulnerable Population
- Vulnerable population selected. Caregiver-specific subject information and informed consent form documents (ICF_Caregiver) are provided in the submission (country-specific ICF/Caregiver documents available), indicating consent considerations for caregivers; adults provide consent via the provided SIS and ICF documents.
Inclusion criteria
- {"criterion_text":"- The participant is within the ages of 18 and 80 years old"}
- {"criterion_text":"- The participant had a kidney transplant (living or deceased donor) at least 6 months before screening"}
- {"criterion_text":"- The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of screening"}
- {"criterion_text":"- A participant may be allowed into the study if they receive the following medications: a) Received mycophenolate mofetil (MMF) for ≥20 weeks before screening b) Has remained on a stable dose of mycophenolate mofetil (MMF) + tacrolimus (TAC) for ≥4 weeks before being allowed to participate in the study c) Has remained on tacrolimus (TAC) doses between 5 to 10 ng/mL ≥4 weeks before being allowed to participate in the study d) Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for ≥4 weeks before being allowed to participate in the study"}
Exclusion criteria
- {"criterion_text":"- Confirmed T-cell or mixed rejection at time of screening"}
- {"criterion_text":"- Recent change in immunosuppressive therapy agents (more information is found in the protocol)"}
- {"criterion_text":"- Any other medical condition that, in the investigator’s opinion, would interfere with the results of the study or put the participant at undue risk"}
- {"criterion_text":"- Pregnant or lactating state or intention to become pregnant during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence and severity of Adverse Events (AEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage of participants with permanent treatment discontinuation due to AEs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Laboratory assessments, vital sign measurements, and ECG","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- eGFR (absolute values and changes from baseline [slope])","definition_or_measurement_approach":"Absolute eGFR values and change from baseline (slope) as stated in endpoint text"}
- {"endpoint_text":"- Histologic changes in kidney biopsy","definition_or_measurement_approach":"Assessment of histologic changes on kidney biopsy as stated in endpoint text"}
- {"endpoint_text":"- Urine Protein Creatinine Ratio","definition_or_measurement_approach":"Urine protein-to-creatinine ratio measurement as stated in endpoint text"}
- {"endpoint_text":"- Graft and participant survival","definition_or_measurement_approach":"Survival outcomes for graft and participant as stated in endpoint text"}
- {"endpoint_text":"- Percentage change from baseline in total IgG levels in serum over time","definition_or_measurement_approach":"Percentage change from baseline in total serum IgG levels over time as stated in endpoint text"}
- {"endpoint_text":"- Efgartigimod serum concentration over time and PK parameter Ctrough","definition_or_measurement_approach":"Serum concentration–time measurements and PK parameter Ctrough as stated in endpoint text"}
- {"endpoint_text":"- Incidence and prevalence of antidrug antibody(ies) (ADA) against efgartigimod in serum over time","definition_or_measurement_approach":"Incidence and prevalence of ADA in serum over time as stated in endpoint text"}
- {"endpoint_text":"- Incidence and prevalence of antibodies against rHuPH20 in plasma over time","definition_or_measurement_approach":"Incidence and prevalence of antibodies against rHuPH20 in plasma over time as stated in endpoint text"}
Recruitment
- Planned Sample Size
- 25
- Recruitment Window Months
- 34
- Consent Approach
- Informed consent via subject information sheets (SIS) and country-specific informed consent forms (ICF_Main) for adults; caregiver ICF documents provided (ICF_Caregiver). ICF/SIS documents available in multiple languages (English, German, French, Dutch, Spanish, Czech) as shown in the submitted SIS/ICF documents per country.
Methods
- Country-specific recruitment arrangements documents (K1/K2) including patient brochures provided for Austria, Belgium, Czechia, Germany, France, Spain
- Flyers and posters (Poster A3) in country-specific languages for Austria, Belgium, Czechia, Germany, France, Spain
- HCP cards (HCP Card) distributed to healthcare professionals (listed among recruitment materials)
- Patient brochures/singles and recruitment flyers (intended for patients) in multiple languages
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 25
Austria
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 15-10-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine III Division of Nephrology and Dialysis
- Contact Person Name
- Georg Böhmig
- Contact Person Email
- nephrologie@meduniwien.ac.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 14-10-2024
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- UZ Leuven
- Department Name
- Nephrology
- Contact Person Name
- Dirk Kuypers
- Contact Person Email
- RDNefro@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Renal Division, Department of Internal Medicine and Pediatrics
- Contact Person Name
- Steven Van Laecke
- Contact Person Email
- studynurses.nephrology@uzgent.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 17-10-2024
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Nephrology
- Contact Person Name
- Ondrej Viklicky
- Contact Person Email
- petr.raska@ikem.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 17-10-2024
- Processing Time Days
- 30
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Clinic for Nephrology and Intensive Care Medicine
- Contact Person Name
- Eva Schrezenmeier
- Contact Person Email
- eva-vanessa.schrezenmeier@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Center for Internal Medicine III
- Contact Person Name
- Florian Grahammer
- Contact Person Email
- transplantation@uke.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medical Clinic III
- Contact Person Name
- Christian Hugo
- Contact Person Email
- nephrologie@uniklinikum-dresden.de
France
- Earliest CTIS Part Ii Submission Date
- 26-09-2024
- Latest Decision Or Authorization Date
- 17-10-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Nephrology
- Contact Person Name
- Paolo Malvezzi
- Contact Person Email
- PMalvezzi@chu-grenoble.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Nephrology
- Contact Person Name
- Lionel Couzi
- Contact Person Email
- sec-transplant.renale@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Nephrology and Transplantation
- Contact Person Name
- Nassim Kamar
- Contact Person Email
- kamar.n@chu-toulouse.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 17-10-2024
- Processing Time Days
- 30
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- Nephrology
- Contact Person Name
- Edoardo Melilli
- Contact Person Email
- secretariaserveinefrologiaihemodialisis@bellvitgehospital.cat
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Nephrology
- Contact Person Name
- Alex Gutierrez-Dalmau
- Contact Person Email
- informacion.sector2@salud.aragon.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nephrology
- Contact Person Name
- Francesc Moreso
- Contact Person Email
- 96365@parcsalutmar.cat
- Site Name
- Hospital Del Mar
- Department Name
- Nephrology
- Contact Person Name
- Marta Crespo
- Contact Person Email
- comunica@vhir.org
Sponsor
Primary sponsor
- Full Name
- Argenx
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- codes 1,12,13,2,5
- Name
- PPD International Holdings LLC
- Responsibilities
- code 4
- Name
- IQVIA Limited
- Responsibilities
- code 8
- Name
- Icon Clinical Research Limited
- Responsibilities
- Home Health Care (code 15)
- Name
- CTI Clinical Trial and Consulting Services Europe GmbH
- Responsibilities
- codes 1,12,2,5
- Name
- Cytel Inc.
- Responsibilities
- codes 10,6,7
Third parties
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROs management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"CTI Clinical Trial and Consulting Services Europe GmbH","duties_or_roles":"codes 1,12,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient reimbursements (code 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Home Health Care (code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"codes 10,6,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"Kidney biopsy reading","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Efgartigimod
- Active Substance
- EFGARTIGIMOD ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- EU MP number PRD11164813; prodAuthStatus 1
- Maximum Dose
- 1000 mg (maxDailyDoseAmount)
- Investigational Product Name
- Placebo PH20 SC – prefilled syringe (placebo to Efgartigimod PH20 SC – prefilled syringe)
- Modality
- Other
- Combination Treatment
- Yes
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