Clinical trial • Phase III|Phase IV • Immunology|Nephrology
IPTACOPAN for IgA nephropathy
Phase III|Phase IV trial of IPTACOPAN for IgA nephropathy. open-label. 440 participants.
Overview
- Trial Therapeutic Area
- Immunology|Nephrology
- Trial Disease
- IgA nephropathy
- Trial Stage
- Phase III|Phase IV
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 26-03-2024
- First CTIS Authorization Date
- 02-05-2024
Trial design
open-label Phase III|Phase IV trial in Italy, Netherlands, Czechia and others.
- Open Label
- Yes
- Target Sample Size
- 440
Eligibility
Recruits 440 Vulnerable population selected (isVulnerablePopulationSelected=true). Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study. ICF templates are provided for adults; a 'Parent Legal Guardian' ICF document is present for France. No paediatric assent documentation is referenced..
- Pregnancy Exclusion
- Pregnant or breastfeeding females, where pregnancy is confirmed by a positive Human Chorionic Gonadotrophin (HCG) test.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study. ICF templates are provided for adults; a 'Parent Legal Guardian' ICF document is present for France. No paediatric assent documentation is referenced.
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study.\n- For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For other parent trials participants must have completed the entire parent trial duration defined by the respective protocol.\n- eGFR* ≥ 20 mL/min/1.73m2. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines).\n- Per Investigator’s clinical judgment, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.\n- Prior vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations).\n- All participants must be on supportive care regimen of stable dose of ACEi or ARB* as per KDIGO guidelines (KDIGO 2021). * Participants with allergies or intolerance to ACEi and ARB are eligible for the study but the Investigator should clearly document the reasons for not being on maximal ACEi/ARB dose in the source documents."}
Exclusion criteria
- {"criterion_text":"- Participants who are screen or baseline failed in any of the iptacopan parent studies in IgAN or who prematurely withdrew from iptacopan parent studies in IgAN for any reason.\n- Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with iptacopan.\n- Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria.\n- Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.\n- Participants treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days prior to first study drug administration. Rituximab requires 180 days wash out. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.\n- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment or within 30 days whichever is longer\n- History of recurrent invasive infections caused by encapsulated organisms, such as Neisseria meningitidis, Streptococcus pneumoniae and Hemophilus influenzae.\n- All transplanted participants (any solid organ, or bone marrow transplantation).\n- Major concurrent comorbidities including but not limited to severe uncontrolled hypertension, other chronic kidney disease (with or without kidney failure), advanced cardiac disease (e.g., NYHA class IV), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV), or hepatic disease (e.g. active hepatitis) that in the opinion of the Investigator precludes participant's participation in the study.\n- Any medical condition deemed likely to interfere with the participant’s participation in the study.\n- Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.\n- Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n- History of Human Immunodeficiency Virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).\n- Liver disease or liver injury as indicated by abnormal liver function tests (LFT) at screening as defined below. ALT (SGPT), AST (SGOT), GGT, alkaline phosphatase and serum bilirubin will be tested. • Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3 × upper limit of normal (ULN) • Serum bilirubin must not exceed 2 × ULN Participants from CLNP023X2203 study or any other parent study participants if required by local regulations will be additionally tested for HBsAg and HCV-RNA and are not eligible if the results are positive.\n- History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes or any participant who discontinued study treatment in the parent study due to a suspected treatment-related AE.\n- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n- Pregnant or breastfeeding females, where pregnancy is confirmed by a positive Human Chorionic Gonadotrophin (HCG) test."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Safety and tolerability endpoints (including but not limited to AEs/SAEs, safety laboratory parameters, vital signs).","definition_or_measurement_approach":"Assessment of adverse events (AEs/SAEs), safety laboratory parameters and vital signs as reported during the open-label treatment period."}
Secondary endpoints
- {"endpoint_text":"- Annualized total eGFR slope.","definition_or_measurement_approach":"Change over time of estimated glomerular filtration rate expressed as an annualized slope."}
- {"endpoint_text":"- Change from baseline in eGFR.","definition_or_measurement_approach":"Difference in eGFR measurements compared to baseline values."}
- {"endpoint_text":"- Log transformed ratio to baseline in UPCR, UACR.","definition_or_measurement_approach":"Log-transformed ratio of urinary protein/creatinine (UPCR) and urine albumin/creatinine (UACR) compared to baseline."}
Recruitment
- Planned Sample Size
- 440
- Recruitment Window Months
- 144
- Consent Approach
- Signed informed consent must be obtained prior to participation in the REP. Consent is provided by the participant (adult). Country-specific ICFs are available (examples in the submission include English, Italian, Dutch, Czech, German, Norwegian, Hungarian, Spanish, Swedish, French, Slovak, Slovenian, Danish). A 'Parent Legal Guardian' ICF document is available for France.
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 100
Italy
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 29-05-2024
- Processing Time Days
- 37
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- 5703: UOC Nefrologia, Dialisi e trapianto
- Principal Investigator Name
- Gaetano La Manna
- Principal Investigator Email
- gaetano.lamanna@unibo.it
- Contact Person Name
- Gaetano La Manna
- Contact Person Email
- gaetano.lamanna@unibo.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- 5702: Cattedra di Nefrologia
- Principal Investigator Name
- Antonio Pisani
- Principal Investigator Email
- antonio.pisani13@gmail.com
- Contact Person Name
- Antonio Pisani
- Contact Person Email
- antonio.pisani13@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- 6100: Nephrology
- Principal Investigator Name
- Mark Eijgelsheim
- Principal Investigator Email
- m.eijgelsheim@umcg.nl
- Contact Person Name
- Mark Eijgelsheim
- Contact Person Email
- m.eijgelsheim@umcg.nl
Czechia
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 4800: 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
Germany
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 14
- Number Of Sites
- 12
- Number Of Participants
- 21
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- 5204: Medizinische Klinik mit Schwerpunkt Nephrologie und Intensivmedizin
- Principal Investigator Name
- Adrian Schreiber
- Principal Investigator Email
- Adrian.schreiber@charite.de
- Contact Person Name
- Adrian Schreiber
- Contact Person Email
- Adrian.schreiber@charite.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 5209: Abteilung für Innere Medizin IV
- Principal Investigator Name
- Wibke Bechtel-Walz
- Principal Investigator Email
- Wibke.bechtelr@uniklinik-freiburg.de
- Contact Person Name
- Wibke Bechtel-Walz
- Contact Person Email
- Wibke.bechtelr@uniklinik-freiburg.de
- Site Name
- Eberhard Karls Universitaet Tuebingen
- Department Name
- 5207: Medizinische Klinik IV, Diabetologie, Endokrinologie, Nephrologie
- Principal Investigator Name
- Ferruh Artunc
- Principal Investigator Email
- ferruh.artunc@med.uni-tuebingen.de
- Contact Person Name
- Ferruh Artunc
- Contact Person Email
- ferruh.artunc@med.uni-tuebingen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 5212: I. Medizinische Klinik und Poliklinik
- 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
- Medizinische Hochschule Hannover
- Department Name
- 5210: Studienzentrum für Nieren- und Hochdruckerkrankungen
- Principal Investigator Name
- Kai Schmidt-Ott
- Principal Investigator Email
- schmidt-ott.kai@mh-hannover.de
- Contact Person Name
- Kai Schmidt-Ott
- Contact Person Email
- schmidt-ott.kai@mh-hannover.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- 5224: Klinik für Innere Medizin IV
- Principal Investigator Name
- Kevin Schulte
- Principal Investigator Email
- Kevin.Schulte@uksh.de
- Contact Person Name
- Kevin Schulte
- Contact Person Email
- Kevin.Schulte@uksh.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- 5220: Medizinische Klinik III
- Principal Investigator Name
- Markus Moeller
- Principal Investigator Email
- mmoeller@ukaachen.de
- Contact Person Name
- Markus Moeller
- Contact Person Email
- mmoeller@ukaachen.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- 5208: Medizinische Klinik und Poliklinik III
- Principal Investigator Name
- Christian Hugo
- Principal Investigator Email
- Christian.hugo@uniklinikum-dresden.de
- Contact Person Name
- Christian Hugo
- Contact Person Email
- Christian.hugo@uniklinikum-dresden.de
- Site Name
- Robert Bosch Krankenhaus GmbH
- Department Name
- 5223: Abteilung für Allgemeine Innere Medizin und Nephrologie
- Principal Investigator Name
- Markus Ketteler
- Principal Investigator Email
- Markus.ketteler@rbk.de
- Contact Person Name
- Markus Ketteler
- Contact Person Email
- Markus.ketteler@rbk.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- 5216: Klinik für Nieren u. Hochdruckkrankheiten, Diabetologie und Endokrinologie
- Principal Investigator Name
- Peter Mertens
- Principal Investigator Email
- Peter.mertens@med.ovgu.de
- Contact Person Name
- Peter Mertens
- Contact Person Email
- Peter.mertens@med.ovgu.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 5201: Klinik für Nephrologie
- Principal Investigator Name
- Anja Gäckler
- Principal Investigator Email
- Anja.gaeckler@uk-essen.de
- Contact Person Name
- Anja Gäckler
- Contact Person Email
- Anja.gaeckler@uk-essen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- 5215: Klinik für Innere Medizin I, Sektion Nephrologie
- Principal Investigator Name
- Lena Schulte-Kemna
- Principal Investigator Email
- Lena.Schulte-Kemna@uniklinik-ulm.de
- Contact Person Name
- Lena Schulte-Kemna
- Contact Person Email
- Lena.Schulte-Kemna@uniklinik-ulm.de
Norway
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 03-05-2024
- Processing Time Days
- 11
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Helse Bergen HF
- Department Name
- 6201: Nefrologisk seksjon
- Principal Investigator Name
- Rannveig Skrunes
- Principal Investigator Email
- rannveig.skrunes@helse-bergen.no
- Contact Person Name
- Rannveig Skrunes
- Contact Person Email
- rannveig.skrunes@helse-bergen.no
- Site Name
- Akershus University Hospital
- Department Name
- 6202: Avdeling for nyresykdommer
- Principal Investigator Name
- Bartlomiej J. Witczak
- Principal Investigator Email
- Bartlomiej.J.Witczak@ahus.no
- Contact Person Name
- Bartlomiej J. Witczak
- Contact Person Email
- Bartlomiej.J.Witczak@ahus.no
Hungary
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 03-05-2024
- Processing Time Days
- 11
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- University Of Pecs
- Department Name
- 5402: II. sz Belgyógyászati Klinika és Nephrológiai Centrum
- Principal Investigator Name
- Tibor Kovács
- Principal Investigator Email
- kovacs.tibor.jozsef@pte.hu
- Contact Person Name
- Tibor Kovács
- Contact Person Email
- kovacs.tibor.jozsef@pte.hu
- Site Name
- University Of Szeged
- Department Name
- 5403: Belgyogyaszati Klinika
- Principal Investigator Name
- László Bitó
- Principal Investigator Email
- bito.laszlo.zsolt@med.u-szeged.hu
- Contact Person Name
- László Bitó
- Contact Person Email
- bito.laszlo.zsolt@med.u-szeged.hu
- Site Name
- University Of Debrecen
- Department Name
- 5401: Belgyógyászati Klinika, Nephrológiai Osztály
- Principal Investigator Name
- János Mátyus
- Principal Investigator Email
- matyus@belklinika.com
- Contact Person Name
- János Mátyus
- Contact Person Email
- matyus@belklinika.com
Spain
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 61
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- 3408: Nefrology
- 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 Clinic De Barcelona
- Department Name
- 3404: Nefrology
- 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
- Clinica Universidad De Navarra
- Department Name
- 3405: Unidad de Ensayos Clinicos
- Principal Investigator Name
- Nuria Garcia Fernandez
- Principal Investigator Email
- nrgarcia@unav.es
- Contact Person Name
- Nuria Garcia Fernandez
- Contact Person Email
- nrgarcia@unav.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- 6700: Forskningsmottagningen Njurmedicin M87
- Principal Investigator Name
- Olof Heimbürger
- Principal Investigator Email
- olof.heimburger@regionstockholm.se
- Contact Person Name
- Olof Heimbürger
- Contact Person Email
- olof.heimburger@regionstockholm.se
France
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- 5103: Centre de Néphrologie et de Transplantation rénale
- Principal Investigator Name
- Bertrand DUSSOL
- Principal Investigator Email
- bertrand.dussol@ap-hm.fr
- Contact Person Name
- Bertrand DUSSOL
- Contact Person Email
- bertrand.dussol@ap-hm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 5101: Service de Néphrologie
- Principal Investigator Name
- Alexandre KARRAS
- Principal Investigator Email
- alexandre.karras@aphp.fr
- Contact Person Name
- Alexandre KARRAS
- Contact Person Email
- alexandre.karras@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 5100: Néphrologie, Soins intensifs, Dialyse et transplantation
- Principal Investigator Name
- Moglie LE QUINTREC-DONNETTE
- Principal Investigator Email
- m-lequintrec-donnette@chu-montpellier.fr
- Contact Person Name
- Moglie LE QUINTREC-DONNETTE
- Contact Person Email
- m-lequintrec-donnette@chu-montpellier.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 15-05-2024
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- 4302: Nefrology
- Principal Investigator Name
- Rowena Vleut
- Principal Investigator Email
- rowena.vleut@uza.be
- Contact Person Name
- Rowena Vleut
- Contact Person Email
- rowena.vleut@uza.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- 4301: Nefrology
- Principal Investigator Name
- An Vanacker
- Principal Investigator Email
- an.vanacker@azdelta.be
- Contact Person Name
- An Vanacker
- Contact Person Email
- an.vanacker@azdelta.be
- Site Name
- UZ Leuven
- Department Name
- 4300: Nefrology
- Principal Investigator Name
- Kathleen Claes
- Principal Investigator Email
- kathleen.claes@uzleuven.be
- Contact Person Name
- Kathleen Claes
- Contact Person Email
- kathleen.claes@uzleuven.be
Slovakia
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 16-08-2024
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- FMC dialyzacne sluzby s.r.o.
- Department Name
- #3600: Nefrologická ambulancia
- Principal Investigator Name
- Jaroslav Rosenberger
- Principal Investigator Email
- jaroslav.rosenberger@freseniusmedicalcare.com
- Contact Person Name
- Jaroslav Rosenberger
- Contact Person Email
- jaroslav.rosenberger@freseniusmedicalcare.com
Slovenia
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 13-08-2024
- Processing Time Days
- 74
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- 3500: Division of Internal Medicine, Department of Nephrology
- Principal Investigator Name
- Andreja Ales Rigler
- Principal Investigator Email
- andreja.ales@kclj.si
- Contact Person Name
- Andreja Ales Rigler
- Contact Person Email
- andreja.ales@kclj.si
- Site Name
- UNIVERZITETNI KLINICNI CENTER MARIBOR
- Department Name
- 3501: Division of Internal medicine, Department of Nephrology
- Principal Investigator Name
- Sebastjan Bevc
- Principal Investigator Email
- sebastjan.bevc@ukc-mb.si
- Contact Person Name
- Sebastjan Bevc
- Contact Person Email
- sebastjan.bevc@ukc-mb.si
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Aalborg University Hospital
- Department Name
- 4901: Dialysen 3.Ø
- Principal Investigator Name
- Jon Waarst Gregersen
- Principal Investigator Email
- jon.gregersen@rn.dk
- Contact Person Name
- Jon Waarst Gregersen
- Contact Person Email
- jon.gregersen@rn.dk
- Site Name
- Rigshospitalet
- Department Name
- 4903: Nefrologisk Klinik P
- Principal Investigator Name
- Mads Hornum
- Principal Investigator Email
- Mads.hornum@regonh.dk
- Contact Person Name
- Mads Hornum
- Contact Person Email
- Mads.hornum@regonh.dk
- Site Name
- Odense University Hospital
- Department Name
- 4902: Klinisk Forskningsenhed, Nyremedicinsk Afdeling Y
- Principal Investigator Name
- Ann-Maria Gramkow
- Principal Investigator Email
- Ann-Maria.Gramkow@rsyd.dk
- Contact Person Name
- Ann-Maria Gramkow
- Contact Person Email
- Ann-Maria.Gramkow@rsyd.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- 4900: Nyremedicinsk Forskning, Nyresygdomme
- Principal Investigator Name
- Per Ramløv Ivarsen
- Principal Investigator Email
- perivars@rm.dk
- Contact Person Name
- Per Ramløv Ivarsen
- Contact Person Email
- perivars@rm.dk
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties: [{"id":980439,"code":"1"},{"id":980440,"code":"3"}], contact eu_clinical_trials_information@iqvia.com
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties: [{"id":980453,"code":"12"}], contact Clinicaltrial.Enquiries@parexel.com
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties: [{"id":980447,"code":"1"}], contact sm_ctis@syneoshealth.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties: [{"id":980443,"code":"1"}], contact Triona.PriceSmith1@docsglobal.com
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties: [{"id":980451,"code":"6"},{"id":980452,"code":"7"}], contact info@medidata.com
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties: [{\"id\":980439,\"code\":\"1\"},{\"id\":980440,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Norway","full_name":"Freja Transport & Logistics AS","duties_or_roles":"Drug destruction and re-labelling (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"sponsorDuties: [{\"id\":980441,\"code\":\"14\"},{\"id\":980442,\"code\":\"15\",\"value\":\"Destruction of IMP Locally purchased drug storage, distribution, and destruction\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties: [{\"id\":980453,\"code\":\"12\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"patient reimbursement (sponsorDuties code 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"sponsorDuties: [{\"id\":980446,\"code\":\"13\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties: [{\"id\":980445,\"code\":\"4\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties: [{\"id\":980447,\"code\":\"1\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: [{\"id\":980451,\"code\":\"6\"},{\"id\":980452,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"Local drug supply Local equipment storage (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Oriola Sweden AB","duties_or_roles":"sponsorDuties: [{\"id\":980449,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"Country depot services, drug distribution, return and destruction and relabeling (sponsorDuties codes 14,15)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Winicker-Norimed Medizinische Forschung GmbH","duties_or_roles":"Upload Study documentation to document management System CREDI (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties: [{\"id\":980443,\"code\":\"1\"}]","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 (prodAuthStatus=1)
- Orphan Designation
- Yes
- Starting Dose
- 200 mg b.i.d.
- Frequency
- b.i.d.
- Maximum Dose
- 400 mg per day
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