Clinical trial • Phase III|Phase IV • Immunology|Rare Disease
IPTACOPAN for C3 glomerulopathy|Idiopathic immune-complex membranoproliferative glomerulonephritis
Phase III|Phase IV trial of IPTACOPAN for C3 glomerulopathy|Idiopathic immune-complex membranoproliferative glomerulonephritis.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- C3 glomerulopathy|Idiopathic immune-complex membranoproliferative glomerulonephritis
- Trial Stage
- Phase III|Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 12-07-2024
- First CTIS Authorization Date
- 21-08-2024
Trial design
open-label, none/not specified-controlled Phase III|Phase IV trial across 34 sites in Czechia, Netherlands, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 148
Eligibility
Recruits 148 paediatric patients.
- Vulnerable Population
- Vulnerable population is selected. The trial includes paediatric participants (adolescents/children). Country-specific informed consent/assent materials are provided (e.g. Parent/Legal Guardian consent forms and Adolescent Assent forms listed for Netherlands, Italy, France, Greece, Spain, Germany and Czechia). Consent is obtained from participants or from parent/legal guardian for minors, with age-appropriate assent documents for adolescents; materials are available in local languages and English as indicated in country-specific documents.
Inclusion criteria
- {"criterion_text":"- Participants must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug."}
Exclusion criteria
- {"criterion_text":"- Severe concurrent co-morbidities, e.g., advanced cardiac disease (New York Heart Association (NYHA) class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating iptacopan or complying with the requirements of the study."}
- {"criterion_text":"- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or The presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening."}
- {"criterion_text":"- History of human immunodeficiency virus (HIV) or any other immunodeficiency disease."}
- {"criterion_text":"- History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Participants from study CLNP023X2202: • Composite renal endpoint met at the 9-month visit if following criteria satisfied: (1) stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR) and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or reduction to <300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL.","definition_or_measurement_approach":"Composite renal endpoint defined by three component criteria measured vs baseline from prior study CLNP023X2202: (1) eGFR change (≤10% reduction allowed), (2) UPCR reduction (≥50% or <300 mg/g), and (3) serum C3 increase (≥50% or ≥90 mg/dL). Assessed at 9 months."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study.","definition_or_measurement_approach":"C3 Deposit Score assessed by immunofluorescence microscopy comparing renal biopsy score to baseline from CLNP023X2202 (measured at 6-9 months for cohort B and at 9 months for cohort A as applicable)."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue).","definition_or_measurement_approach":"Safety endpoints: clinically significant changes in vital signs (msDBP, msSBP, heart rate), ECG abnormalities, safety labs, and collection/assessment of AEs, AEs of special interest, and discontinuations due to AEs across study visits."}
- {"endpoint_text":"- Participants from studies CLNP023B12301 or CLNP023B12302: • Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue).","definition_or_measurement_approach":"Safety endpoints as above for participants enrolled from CLNP023B12301/CLNP023B12302: clinical vitals, ECGs, safety labs, AEs and discontinuations."}
Secondary endpoints
- {"endpoint_text":"- Participants from study CLNP023X2202: • Composite renal endpoint met at the 9-month visit if following criteria satisfied: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to <300 mg/g in UPCR.","definition_or_measurement_approach":"As defined for primary composite renal endpoint but specified as secondary in this listing; measured at 9 months vs CLNP023X2202 baseline (eGFR and UPCR)."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Change from baseline in log-transformed urine protein/creatinine ratio (UPCR), change from baseline in log-transformed urine albumin/creatinine ratio (UACR), change from baseline in serum creatinine concentration and change from baseline in estimated glomerular filtration rate (eGFR) at the 9-month visit in CLNP023B12001B.","definition_or_measurement_approach":"Continuous renal function and proteinuria measures: log-transformed UPCR and UACR, serum creatinine, eGFR changes at 9 months vs baseline."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Change from baseline in log-transformed urine protein/creatinine ratio (UPCR) and change from baseline in log-transformed urine albumin/creatinine ratio (UACR), at the 3-month visit in CLNP023B12001B.","definition_or_measurement_approach":"Log-transformed UPCR and UACR change at 3 months vs baseline."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Disease activity and chronicity scores from a renal biopsy at 6 to 9 months from entry to the CLNP023B12001B study. Biopsies will be compared to those obtained in the CLNP023X2202 study (if available).","definition_or_measurement_approach":"Renal biopsy histopathology scoring for disease activity and chronicity at 6-9 months compared to prior biopsies from CLNP023X2202."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Log-transformed ratio to baseline in serum C3 at the 9-month visit in CLNP023B12001B.","definition_or_measurement_approach":"Log-transformed ratio of serum C3 vs baseline, measured at 9 months."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Composite renal endpoint met at times >9 months if following criteria satisfied: (1) stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to <300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL.","definition_or_measurement_approach":"Composite renal endpoint criteria assessed at timepoints >9 months using eGFR, UPCR and serum C3."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Change from baseline in log-transformed UPCR, log-transformed UACR, serum creatinine concentration and estimated glomerular filtration rate (eGFR) at times >9 months in CLNP023B12001B. Change in eGFR slope.","definition_or_measurement_approach":"Longer-term changes (>9 months) in log-UPCR, log-UACR, serum creatinine and eGFR, including eGFR slope analysis."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Log-transformed ratio to baseline in serum C3 at times >9 months in CLNP023B12001B.","definition_or_measurement_approach":"Log-transformed serum C3 ratio vs baseline at >9 months."}
- {"endpoint_text":"- Participants from study CLNP023X2202: • Determine plasma iptacopan concentration up to 12 months at trough.","definition_or_measurement_approach":"Pharmacokinetic measurement: trough plasma iptacopan concentrations up to 12 months."}
- {"endpoint_text":"- Participants from studies CLNP023B12301 or CLNP023B12302: • Change from initiation of iptacopan treatment in the core study in log-transformed UPCR over time.","definition_or_measurement_approach":"Change over time in log-transformed UPCR measured from initiation of iptacopan in core study."}
- {"endpoint_text":"- Participants from studies CLNP023B12301 or CLNP023B12302: • Change from initiation of iptacopan treatment in the core study in eGFR over time.","definition_or_measurement_approach":"Longitudinal eGFR change from initiation of iptacopan in core study."}
- {"endpoint_text":"- Participants from studies CLNP023B12301 or CLNP023B12302: • Composite renal endpoint met if following criteria satisfied (1) eGFR (a stable or improved eGFR, i.e., ≤15% reduction in eGFR compared to the initiation of iptacopan treatment in the core study) and (2) UPCR (≥50% reduction in UPCR compared to the initiation of iptacopan treatment in the core study).","definition_or_measurement_approach":"Composite renal endpoint for CLNP023B12301/12302 defined by eGFR (≤15% reduction) and UPCR (≥50% reduction) relative to iptacopan initiation in core study."}
Recruitment
- Planned Sample Size
- 148
- Recruitment Window Months
- 202
- Consent Approach
- Informed consent is collected using country-specific subject information and informed consent forms. For adult participants the Main ICF is used; for minors Parent/Legal Guardian consent forms and Adolescent Assent forms are provided (documents listed for Netherlands, Italy, France, Greece, Spain, Germany, Czechia). Documents are provided in local languages and English where indicated. Separate data protection consent and optional assessment consent forms are available; follow-up information for pregnant participants is provided.
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 50
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- #1601: Klinika nefrologie
- Principal Investigator Name
- Vladimir Tesar
- Principal Investigator Email
- vladimir.tesar@vfn.cz
- Contact Person Name
- Vladimir Tesar
- Contact Person Email
- vladimir.tesar@vfn.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- #3702: Paediatrics
- Principal Investigator Name
- Nicole van de Kar
- Principal Investigator Email
- nicole.vandekar@radboudumc.nl
- Contact Person Name
- Nicole van de Kar
- Contact Person Email
- nicole.vandekar@radboudumc.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- #3701: Nephrology
- Principal Investigator Name
- Aiko De Vries
- Principal Investigator Email
- a.p.j.de_vries@lumc.nl
- Contact Person Name
- Aiko De Vries
- Contact Person Email
- a.p.j.de_vries@lumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 53
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- #3002: U.O.Nefrologia e Dialisi
- Principal Investigator Name
- Marina Vivarelli
- Principal Investigator Email
- marina.vivarelli@opbg.net
- Contact Person Name
- Marina Vivarelli
- Contact Person Email
- marina.vivarelli@opbg.net
- Site Name
- Istituto Di Ricerche Farmacologiche Mario Negri
- Department Name
- #3001: Centro ricerche cliniche per Malattie rare Aldo e Cele Daccò
- Principal Investigator Name
- Giuseppe Remuzzi
- Principal Investigator Email
- giuseppe.remuzzi@marionegri.it
- Contact Person Name
- Giuseppe Remuzzi
- Contact Person Email
- giuseppe.remuzzi@marionegri.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- #3003: S.C.Nefrologia e Dialisi Pediatrica- Trapianto di Rene
- Principal Investigator Name
- Giovanni Montini
- Principal Investigator Email
- giovanni.montini@unimi.it
- Contact Person Name
- Giovanni Montini
- Contact Person Email
- giovanni.montini@unimi.it
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- #3004 : U.O. Nefrologia Universitaria Dip. Emergenza e Trapianti d'Organo
- Principal Investigator Name
- Loreto Gesualdo
- Principal Investigator Email
- loreto.gesualdo@uniba.it
- Contact Person Name
- Loreto Gesualdo
- Contact Person Email
- loreto.gesualdo@uniba.it
France
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 20
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- #1002: Service de Néphrologie, Dialyse et transplantation rénale
- Principal Investigator Name
- Moglie Le Quintrec
- Principal Investigator Email
- m-lequintrec-donnette@chu-montpellier.fr
- Contact Person Name
- Moglie Le Quintrec
- Contact Person Email
- m-lequintrec-donnette@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- #1003: Service de Néphrologie
- Principal Investigator Name
- Alexandre Karras
- Principal Investigator Email
- alexandre.karras@egp.aphp.fr
- Contact Person Name
- Alexandre Karras
- Contact Person Email
- alexandre.karras@egp.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- 1008: Nephrologie
- Principal Investigator Name
- Manon Martins
- Principal Investigator Email
- manon.martins@chu-rennes.fr
- Contact Person Name
- Manon Martins
- Contact Person Email
- manon.martins@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- #1006: Service de Néphrologie et Transplatation d'organes
- Principal Investigator Name
- David Ribes
- Principal Investigator Email
- ribes.d@chu-toulouse.fr
- Contact Person Name
- David Ribes
- Contact Person Email
- ribes.d@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- #1005: Service de Néphrologie et Transplantation adulte
- Principal Investigator Name
- Aude Servais
- Principal Investigator Email
- aude.servais@aphp.fr
- Contact Person Name
- Aude Servais
- Contact Person Email
- aude.servais@aphp.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 20
- Number Of Sites
- 8
- Number Of Participants
- 8
Sites
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 1705 : Nephrology and Artificial Kidney Unit
- Principal Investigator Name
- Sophia Lionaki
- Principal Investigator Email
- sofia.lionaki@gmail.com
- Contact Person Name
- Sophia Lionaki
- Contact Person Email
- sofia.lionaki@gmail.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 1704 : Internal Medicine Sector - Second Nephrology Clinic
- Principal Investigator Name
- Vassilios Liakopoulos
- Principal Investigator Email
- liakopul@otenet.gr
- Contact Person Name
- Vassilios Liakopoulos
- Contact Person Email
- liakopul@otenet.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 1702: 1st Pediatric Department
- Principal Investigator Name
- Styliani (Stella) Stampouli (Stabouli)
- Principal Investigator Email
- sstaboul@auth.gr
- Contact Person Name
- Styliani (Stella) Stampouli (Stabouli)
- Contact Person Email
- sstaboul@auth.gr
- Site Name
- Hippokration Hospital
- Department Name
- 1708:Internal Medicine Sector - Department of Nephrology
- Principal Investigator Name
- Dimitrios Petras
- Principal Investigator Email
- petrasdim@hotmail.com
- Contact Person Name
- Dimitrios Petras
- Contact Person Email
- petrasdim@hotmail.com
- Site Name
- University General Hospital Of Ioannina
- Department Name
- 1706: Nephrology Clinic
- Principal Investigator Name
- Evangelia Ntounousi
- Principal Investigator Email
- edounous@uoi.gr
- Contact Person Name
- Evangelia Ntounousi
- Contact Person Email
- edounous@uoi.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- #1701: Nephrology Department
- Principal Investigator Name
- Konstantinos Stylianou
- Principal Investigator Email
- kstylianu@gmail.com
- Contact Person Name
- Konstantinos Stylianou
- Contact Person Email
- kstylianu@gmail.com
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- 1703:1st Internal Medicine Sector, Nephrology department
- Principal Investigator Name
- Gerasimos Bamichas
- Principal Investigator Email
- gbamichas@gmail.com
- Contact Person Name
- Gerasimos Bamichas
- Contact Person Email
- gbamichas@gmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- 1707 : Nephrology Center
- Principal Investigator Name
- Evangelos Papachristou
- Principal Investigator Email
- epapadoct@hotmail.com
- Contact Person Name
- Evangelos Papachristou
- Contact Person Email
- epapadoct@hotmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 21-08-2024
- Processing Time Days
- 19
- Number Of Sites
- 9
- Number Of Participants
- 9
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- #4009: Nefrología
- Principal Investigator Name
- Jose Maria Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose Maria Mora Gutierrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #4010: Nefrología Pediátrica
- Principal Investigator Name
- Gema Ariceta Iraola
- Principal Investigator Email
- gema.ariceta@vallhebron.cat
- Contact Person Name
- Nicole van de Kar
- Contact Person Email
- gema.ariceta@radboudumc.nl
- Site Name
- Hospital Clinico San Carlos
- Department Name
- #4006: Nefrología
- Principal Investigator Name
- Antolina Rodriguez Moreno
- Principal Investigator Email
- antolina.rodriguez@salud.madrid.org
- Contact Person Name
- Antolina Rodriguez Moreno
- Contact Person Email
- antolina.rodriguez@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- #4001: Nefrología
- Principal Investigator Name
- Teresa Cavero Escribano
- Principal Investigator Email
- tcaveroescribano@gmail.com
- Contact Person Name
- Teresa Cavero Escribano
- Contact Person Email
- tcaveroescribano@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- #4008: Nefrología
- Principal Investigator Name
- Jose Maria Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose Maria Mora Gutierrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- #4005: Nefrología
- Principal Investigator Name
- Luis Fernando Quintana Porras
- Principal Investigator Email
- LFQUINTA@clinic.cat
- Contact Person Name
- Luis Fernando Quintana Porras
- Contact Person Email
- LFQUINTA@clinic.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- #4007: Nefrología
- Principal Investigator Name
- Maria Pilar Fraile Gomez
- Principal Investigator Email
- pilarfg@usal.es
- Contact Person Name
- Maria Pilar Fraile Gomez
- Contact Person Email
- pilarfg@usal.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- #4004: Nefrología
- Principal Investigator Name
- Mercedes Salgueira Lazo
- Principal Investigator Email
- mercedes.salgueira.sspa@juntadeandalucia.es
- Contact Person Name
- Mercedes Salgueira Lazo
- Contact Person Email
- mercedes.salgueira.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Vall D Hebron
- Department Name
- #4003: Nefrología
- Principal Investigator Name
- Maria Jose Soler Romero
- Principal Investigator Email
- mariajose.soler@vallhebron.cat
- Contact Person Name
- Maria Jose Soler Romero
- Contact Person Email
- mariajose.soler@vallhebron.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 20
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- #2007: Medizinische Klinik 4
- Principal Investigator Name
- Michael Wiesener
- Principal Investigator Email
- Michael.Wiesener@uk-erlangen.de
- Contact Person Name
- Michael Wiesener
- Contact Person Email
- Michael.Wiesener@uk-erlangen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- #2002: Klinik für Nephrologie
- Principal Investigator Name
- Ute Eisenberger
- Principal Investigator Email
- ute.eisenberger@uk-essen.de
- Contact Person Name
- Ute Eisenberger
- Contact Person Email
- ute.eisenberger@uk-essen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- #2009: III. Medizinische Klinik und Poliklinik, Nephrologie
- Principal Investigator Name
- Malte Kluger
- Principal Investigator Email
- m.kluger@uke.de
- Contact Person Name
- Malte Kluger
- Contact Person Email
- m.kluger@uke.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- #2005: I. Medizinische Klinik und Poliklinik, Nephrologie
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- julia.weinmann-menke@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- #2010: Klinik Kinderheilkunde I
- Principal Investigator Name
- Christian Patry
- Principal Investigator Email
- Christian.Patry@med.uni-heidelberg.de
- Contact Person Name
- Christian Patry
- Contact Person Email
- Christian.Patry@med.uni-heidelberg.de
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Bioclinica Inc.
- Responsibilities
- sponsorDuties codes: [5,6]; clinical data/operations support (contact: Tamas.Fulop@clario.com)
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- sponsorDuties codes: [1]; CRO operations (contact: ICONGreekAffiliateMailbox@iconplc.com)
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties codes: [1]; CRO operations (contact: sm_ctis@syneoshealth.com)
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [1]; CRO operations (contact: Triona.PriceSmith1@docsglobal.com)
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: [12]; specific CRO responsibilities (contact: Clinicaltrial.Enquiries@parexel.com)
- Name
- IQVIA Limited / Iqvia Biotech LLC
- Responsibilities
- sponsorDuties codes: [1] and [3]; IRT/QC and clinical operations (contact: eu_clinical_trials_information@iqvia.com / IRT-QATeamDL@iqvia.com)
- Name
- Veeda Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [4]; local clinical study operations (contact: info@veedacr.com)
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [5,6]; contact email: Tamas.Fulop@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: [1]; contact email: ICONGreekAffiliateMailbox@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"sponsorDuties: TMF archive","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]; contact email: sm_ctis@syneoshealth.com","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [4]; contact email: info@veedacr.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"sponsorDuties: Patients tools - IMP Safety Card","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties: CCI","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"sponsorDuties: CCI","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties: Patient travel and accommodation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]; contact email: Triona.PriceSmith1@docsglobal.com","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"sponsorDuties codes: [4]; contact email: Samples-dk@eurofins.dk","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: [4]; contact email: fr.saint-benoit.sales@sgs.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]; contact email: info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]; contact email: q2_eu_clinical_trials_information@q2labsolutions.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties codes: [3]; contact email: IRT-QATeamDL@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]; contact email: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
- {"country":"Cyprus","full_name":"Clinbay Limited","duties_or_roles":"sponsorDuties codes: [10]; contact email: info@clinbay.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1]; contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"sponsorDuties codes: [4]; contact email: SH-Breda_StudyManagement_BioMarkers@bcl.eurofins.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- IPTACOPAN
- Active Substance
- IPTACOPAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 400 mg
- Investigational Product Name
- IPTACOPAN HYDROCHLORIDE
- Active Substance
- IPTACOPAN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 400 mg
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