Clinical trial • Phase III • Immunology|Rare Disease
DAZODALIBEP for Sjögren's syndrome
Phase III trial of DAZODALIBEP for Sjögren's syndrome. Randomised, open-label. 507 participants.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Sjögren's syndrome
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 19-12-2024
- First CTIS Authorization Date
- 29-04-2025
Trial design
Randomised, open-label Phase III trial across 86 sites in Croatia, Denmark, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Target Sample Size
- 507
- Trial Duration For Participant
- 1455
Eligibility
Recruits 507 The trial identifies vulnerable populations (isVulnerablePopulationSelected = true) primarily in the context of pregnancy, lactation and infant/newborn follow‑up. Country-specific information and informed consent forms are provided for father/mother/infant, lactation, pregnancy/infant follow-up and paediatric caregiver/genetic testing (e.g. Father-Infant ICF, Mother-Infant ICF, Lactation ICF, Information re Genetic Testing - Paediatric Caregiver ICF). Consent is required from the adult participant prior to any study procedures; for infant/paediatric assessments consent is obtained from the parent(s)/caregiver(s) (parental/caregiver consent forms are included). Assent processes for minors are not detailed in the CTIS record..
- Pregnancy Exclusion
- 206 Female participants of childbearing potential unwilling to use protocol-specified method of contraception see (Section 11.5) during treatment and for an additional 12 weeks after the last dose of investigational product 207 Female participants who are breastfeeding or who plan to breastfeed while on study through 12 weeks after the last dose of investigational product. 208 Female participants planning to become pregnant or donate eggs while on study through 12 weeks after the last dose of investigational product. 209 Female participants of childbearing potential with a positive pregnancy test assessed at day 1 by a highly sensitive urine pregnancy test.
- Vulnerable Population
- The trial identifies vulnerable populations (isVulnerablePopulationSelected = true) primarily in the context of pregnancy, lactation and infant/newborn follow‑up. Country-specific information and informed consent forms are provided for father/mother/infant, lactation, pregnancy/infant follow-up and paediatric caregiver/genetic testing (e.g. Father-Infant ICF, Mother-Infant ICF, Lactation ICF, Information re Genetic Testing - Paediatric Caregiver ICF). Consent is required from the adult participant prior to any study procedures; for infant/paediatric assessments consent is obtained from the parent(s)/caregiver(s) (parental/caregiver consent forms are included). Assent processes for minors are not detailed in the CTIS record.
Inclusion criteria
- {"criterion_text":"- 1. Participant has provided informed consent before initiation of any study-specific activities/procedures.\n- 2. Must have been eligible to receive and have received investigational product (dazodalibep or placebo) and completed the study in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). Note: Participants who prematurely discontinued investigational product are not eligible for this study.\n- 3. Be able to receive Dose 1 of this LTE study prior pivotal phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). Note: Participants may be enrolled in the LTE after this window at the principal investigator’s discretion, but after consultation with the medical monitor."}
Exclusion criteria
- {"criterion_text":"- 201 Clinically significant active infection in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.\n- 213 Participant has known sensitivity to any of the products or components to be administered during dosing.\n- 214 Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator’s knowledge.\n- 215 History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.\n- 202 Concurrent Clinical Study Experience Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.\n- 203 Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with investigational product administration.\n- 204 Planned surgeries or hospitalizations that, in the opinion of the investigator or the sponsor, would interfere with evaluation and interpretation of participant safety.\n- 205 Individuals who plan to receive live (attenuated) vaccine during the LTE study\n- 206 Female participants of childbearing potential unwilling to use protocol-specified method of contraception see (Section 11.5) during treatment and for an additional 12 weeks after the last dose of investigational product\n- 207 Female participants who are breastfeeding or who plan to breastfeed while on study through 12 weeks after the last dose of investigational product.\n- 208 Female participants planning to become pregnant or donate eggs while on study through 12 weeks after the last dose of investigational product.\n- 209 Female participants of childbearing potential with a positive pregnancy test assessed at day 1 by a highly sensitive urine pregnancy test."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest (AESIs).","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1.Development of positive anti-drug antibodies (ADAs) during the study.","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2. Plasma concentration of dazodalibep.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 507
- Recruitment Window Months
- 47
- Consent Approach
- Informed consent must be provided before initiation of any study-specific activities; a main participant informed consent form is used. Multiple country- and situation-specific consent documents are provided (main ICFs, father/mother/infant ICFs, lactation ICFs, pregnancy and infant follow-up ICFs, optional program ICFs, concierge/transportation/future research optional ICFs). Consent for adult participants is provided by the participant; parental/caregiver consent forms are provided for infant/paediatric assessments. Country-specific language versions of ICFs are available (examples in the CTIS documents include Croatian, Danish, French, Dutch, English, German, Hungarian, Portuguese, Polish, Spanish, Italian, Greek, Slovenian).
Geography
- Total Number Of Sites
- 86
- Total Number Of Participants
- 337
Croatia
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 38
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- KBC Zagreb
- Department Name
- Clinic for rheumatic diseases and rehabilitation
- Principal Investigator Name
- Porin Peric
- Principal Investigator Email
- predstojnik.fmr@kbc-zagreb.hr
- Contact Person Name
- Porin Peric
- Contact Person Email
- predstojnik.fmr@kbc-zagreb.hr
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Rheumatology, Allergology and Clinical Immunology
- Principal Investigator Name
- Jasminka Milas Ahic
- Principal Investigator Email
- milas-ahic.jasminka@kbco.hr
- Contact Person Name
- Jasminka Milas Ahic
- Contact Person Email
- milas-ahic.jasminka@kbco.hr
- Site Name
- KBC Split
- Department Name
- Rheumatology, Allergology and Clinical Immunology
- Principal Investigator Name
- Dijana Perkovic
- Principal Investigator Email
- dperkov@kbsplit.hr
- Contact Person Name
- Dijana Perkovic
- Contact Person Email
- dperkov@kbsplit.hr
- Site Name
- University Hospital Sveti Duh
- Department Name
- Physical Medicine and Rehabilitation
- Principal Investigator Name
- Ksenija Mastrovic Radoncic
- Principal Investigator Email
- kmastrovic@kbsd.hr
- Contact Person Name
- Ksenija Mastrovic Radoncic
- Contact Person Email
- kmastrovic@kbsd.hr
- Site Name
- Poliklinika BONIFARM
- Principal Investigator Name
- Marinko Bilusic
- Principal Investigator Email
- mbilusic@bonifarm.hr
- Contact Person Name
- Marinko Bilusic
- Contact Person Email
- mbilusic@bonifarm.hr
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Odense University Hospital
- Department Name
- Depart. of Rheumatology
- Principal Investigator Name
- Torkell Juulsgaard Ellingsen
- Principal Investigator Email
- torkell.ellingsen@rsyd.dk
- Contact Person Name
- Torkell Juulsgaard Ellingsen
- Contact Person Email
- torkell.ellingsen@rsyd.dk
- Site Name
- Aarhus University Hospital
- Department Name
- Depart. of Rheumatology
- Principal Investigator Name
- Ellen-Margrethe Hauge
- Principal Investigator Email
- ellhau@rm.dk
- Contact Person Name
- Ellen-Margrethe Hauge
- Contact Person Email
- ellhau@rm.dk
France
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 34
- Number Of Sites
- 7
- Number Of Participants
- 28
Sites
- Site Name
- Bicetre Hospital
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Raphaèle SEROR
- Principal Investigator Email
- Raphaele.seror@aphp.fr
- Contact Person Name
- Raphaèle SEROR
- Contact Person Email
- Raphaele.seror@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service de Médicine interne et immunologie clinique
- Principal Investigator Name
- Noémie GENSOUS
- Principal Investigator Email
- noemie.gensous@chu-bordeaux.fr
- Contact Person Name
- Noémie GENSOUS
- Contact Person Email
- noemie.gensous@chu-bordeaux.fr
- Site Name
- Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
- Department Name
- Service de Médicine interne et immunologie clinique
- Principal Investigator Name
- Benjamin DERVIEUX
- Principal Investigator Email
- benjamin.dervieux@ghrmsa.fr
- Contact Person Name
- Benjamin DERVIEUX
- Contact Person Email
- benjamin.dervieux@ghrmsa.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Médicine Interne
- Principal Investigator Name
- Vincent JACHIET
- Principal Investigator Email
- vincent.jachiet@aphp.fr
- Contact Person Name
- Vincent JACHIET
- Contact Person Email
- vincent.jachiet@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Valérie DEVAUCHELLE-PENSEC
- Principal Investigator Email
- valerie.devauchellepensec@chubrest.fr
- Contact Person Name
- Valérie DEVAUCHELLE-PENSEC
- Contact Person Email
- valerie.devauchellepensec@chubrest.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Jacques Eric GOTTENBERG
- Principal Investigator Email
- jacques-eric.gottenberg@chustrasbourg.fr
- Contact Person Name
- Jacques Eric GOTTENBERG
- Contact Person Email
- jacques-eric.gottenberg@chustrasbourg.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest (duplicate entry in listing)
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Valérie DEVAUCHELLE-PENSEC
- Principal Investigator Email
- valerie.devauchellepensec@chubrest.fr
- Contact Person Name
- Valérie DEVAUCHELLE-PENSEC
- Contact Person Email
- valerie.devauchellepensec@chubrest.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 30-04-2025
- Processing Time Days
- 33
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Rheumatology department
- Principal Investigator Name
- Isabelle Peene
- Principal Investigator Email
- isabelle.peene@uzgent.be
- Contact Person Name
- Isabelle Peene
- Contact Person Email
- isabelle.peene@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Rheumatology department
- Principal Investigator Name
- Ellen De Langhe
- Principal Investigator Email
- ellen.delanghe@uzleuven.be
- Contact Person Name
- Ellen De Langhe
- Contact Person Email
- ellen.delanghe@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 30-04-2025
- Processing Time Days
- 72
- Number Of Sites
- 5
- Number Of Participants
- 27
Sites
- Site Name
- Rheumazentrum Greifswald
- Principal Investigator Name
- Michael Fiene
- Principal Investigator Email
- michael.fiene@rheumazentrumgreifswald.info
- Contact Person Name
- Michael Fiene
- Contact Person Email
- michael.fiene@rheumazentrumgreifswald.info
- Site Name
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
- Principal Investigator Name
- Andrea Everding
- Principal Investigator Email
- everding@hotmail.de
- Contact Person Name
- Andrea Everding
- Contact Person Email
- everding@hotmail.de
- Site Name
- Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen
- Department Name
- Hautklinik
- Principal Investigator Name
- Martin Kaatz
- Principal Investigator Email
- Kaatz.Martin@drk-khs.de
- Contact Person Name
- Martin Kaatz
- Contact Person Email
- Kaatz.Martin@drk-khs.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Hämatologie, Onkologie, Rheumatologie Sektion Rheumatologie
- Principal Investigator Name
- Norbert Blank
- Principal Investigator Email
- norbert.blank@med.uni-heidelberg.de
- Contact Person Name
- Norbert Blank
- Contact Person Email
- norbert.blank@med.uni-heidelberg.de
- Site Name
- BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
- Principal Investigator Name
- Gunther Neeck
- Principal Investigator Email
- gunther.neeck@biomedro.de
- Contact Person Name
- Gunther Neeck
- Contact Person Email
- gunther.neeck@biomedro.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 07-03-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 53
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Vasarhelyi Sarkanyfu Kft.
- Principal Investigator Name
- Éva BALÁZS
- Principal Investigator Email
- jimbies@gmail.hu
- Contact Person Name
- Éva BALÁZS
- Contact Person Email
- jimbies@gmail.hu
- Site Name
- University Of Debrecen
- Principal Investigator Name
- Antónia SZÁNTÓ
- Principal Investigator Email
- szanto.antonia@med.unideb.hu
- Contact Person Name
- Antónia SZÁNTÓ
- Contact Person Email
- szanto.antonia@med.unideb.hu
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Principal Investigator Name
- Tibor MARTYIN
- Principal Investigator Email
- martyintibor@freemail.hu
- Contact Person Name
- Tibor MARTYIN
- Contact Person Email
- martyintibor@freemail.hu
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Principal Investigator Name
- János KÁDÁR
- Principal Investigator Email
- drkadarj@t-online.hu
- Contact Person Name
- János KÁDÁR
- Contact Person Email
- drkadarj@t-online.hu
Portugal
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 56
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Unidade Local De Saude De Lisboa Ocidental E.P.E.
- Department Name
- Rheumatology Service
- Principal Investigator Name
- Fernando Pimentel Santos
- Principal Investigator Email
- pimentel.santos@nms.unl.pt
- Contact Person Name
- Fernando Pimentel Santos
- Contact Person Email
- pimentel.santos@nms.unl.pt
- Site Name
- Unidade Local De Saude Do Alto Minho E.P.E.
- Department Name
- Reumatology Service
- Principal Investigator Name
- Daniela Peixoto
- Principal Investigator Email
- danielapeixoto81@hotmail.com
- Contact Person Name
- Daniela Peixoto
- Contact Person Email
- danielapeixoto81@hotmail.com
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Reumatology
- Principal Investigator Name
- Taciana Videira
- Principal Investigator Email
- taciana.videira@ulsge.min-saude.pt
- Contact Person Name
- Taciana Videira
- Contact Person Email
- taciana.videira@ulsge.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Reumatology
- Principal Investigator Name
- Nikita Khmelinskii
- Principal Investigator Email
- nkhmelinskii@gmail.com
- Contact Person Name
- Nikita Khmelinskii
- Contact Person Email
- nkhmelinskii@gmail.com
Slovenia
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 98
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Ziga Rotar Clinical
- Principal Investigator Email
- ziga.rotar@kclj.si
- Contact Person Name
- Ziga Rotar Clinical
- Contact Person Email
- ziga.rotar@kclj.si
- Site Name
- UNIVERZITETNI KLINICNI CENTER MARIBOR
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Iztok Holc
- Principal Investigator Email
- Iztok.HOLC@ukc-mb.si
- Contact Person Name
- Iztok Holc
- Contact Person Email
- Iztok.HOLC@ukc-mb.si
Poland
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 04-05-2025
- Processing Time Days
- 18
- Number Of Sites
- 28
- Number Of Participants
- 93
Sites
- Site Name
- Pratia S.A.
- Department Name
- Pratia Poznań
- Principal Investigator Name
- Magdalena Szyszko
- Principal Investigator Email
- magdalena.szyszko@pratia.com
- Contact Person Name
- Magdalena Szyszko
- Contact Person Email
- magdalena.szyszko@pratia.com
- Site Name
- Reumed Sp. z o.o.
- Principal Investigator Name
- Mariusz Piotrowski
- Principal Investigator Email
- mariusz_piotrowski@yahoo.com
- Contact Person Name
- Mariusz Piotrowski
- Contact Person Email
- mariusz_piotrowski@yahoo.com
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- FutureMeds Targówek
- Principal Investigator Name
- Agnieszka Jurek-Urbanowska
- Principal Investigator Email
- agnieszka.urbanowska@futuremeds.com
- Contact Person Name
- Agnieszka Jurek-Urbanowska
- Contact Person Email
- agnieszka.urbanowska@futuremeds.com
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- FutureMeds Wrocław
- Principal Investigator Name
- Ewa Krecipro-Nizińska
- Principal Investigator Email
- ewa.krecipro-nizinska@futuremeds.com
- Contact Person Name
- Ewa Krecipro-Nizińska
- Contact Person Email
- ewa.krecipro-nizinska@futuremeds.com
- Site Name
- Pratia S.A.
- Department Name
- Centrum Medyczne Pratia Katowice
- Principal Investigator Name
- Tomasz Dziewit
- Principal Investigator Email
- tdziewit@poczta.onet.pl
- Contact Person Name
- Tomasz Dziewit
- Contact Person Email
- tdziewit@poczta.onet.pl
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Department Name
- Centrum Medyczne Reuma Park
- Principal Investigator Name
- Paula Śliwińska-Stańczyk
- Principal Investigator Email
- stanczyki@post.pl
- Contact Person Name
- Paula Śliwińska-Stańczyk
- Contact Person Email
- stanczyki@post.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Reumatologii i Chorób Wewnętrznych
- Principal Investigator Name
- Piotr Wiland
- Principal Investigator Email
- pwiland1@gmail.com
- Contact Person Name
- Piotr Wiland
- Contact Person Email
- pwiland1@gmail.com
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- FutureMeds Łódź
- Principal Investigator Name
- Katarzyna Bartnicka-Masłowska
- Principal Investigator Email
- katarzyna.bartnicka@futuremeds.com
- Contact Person Name
- Katarzyna Bartnicka-Masłowska
- Contact Person Email
- katarzyna.bartnicka@futuremeds.com
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Robert Rupiński
- Principal Investigator Email
- rupinski@mp.pl
- Contact Person Name
- Robert Rupiński
- Contact Person Email
- rupinski@mp.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Principal Investigator Name
- Małgorzata Socik-Pojawa
- Principal Investigator Email
- m.pojawa@etg-network.com
- Contact Person Name
- Małgorzata Socik-Pojawa
- Contact Person Email
- m.pojawa@etg-network.com
- Site Name
- ETG Lubllin
- Principal Investigator Name
- Barbara Nieradko-Iwanicka
- Principal Investigator Email
- bb.nieradkoiwanicka@etg-network.com
- Contact Person Name
- Barbara Nieradko-Iwanicka
- Contact Person Email
- bb.nieradkoiwanicka@etg-network.com
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Brygida Kwiatkowska
- Principal Investigator Email
- kwiatkowskabrygida@gmail.com
- Contact Person Name
- Brygida Kwiatkowska
- Contact Person Email
- kwiatkowskabrygida@gmail.com
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Principal Investigator Name
- Joanna Kur-Zalewska
- Principal Investigator Email
- jkur-zalewska@wim.mil.pl
- Contact Person Name
- Joanna Kur-Zalewska
- Contact Person Email
- jkur-zalewska@wim.mil.pl
- Site Name
- Promed P.Lach R.Glowacki Sp. j.
- Principal Investigator Name
- Piotr Łach
- Principal Investigator Email
- piotr@cmpromed.pl
- Contact Person Name
- Piotr Łach
- Contact Person Email
- piotr@cmpromed.pl
- Site Name
- Pracownia Badan Klinicznych Salus
- Principal Investigator Name
- Katarzyna Rachwał-Siek
- Principal Investigator Email
- katarzyna.rachwal-siek@pbks.com.pl
- Contact Person Name
- Katarzyna Rachwał-Siek
- Contact Person Email
- katarzyna.rachwal-siek@pbks.com.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Principal Investigator Name
- Rafał Wojciechowski
- Principal Investigator Email
- r.wojciechowski@wp.eu
- Contact Person Name
- Rafał Wojciechowski
- Contact Person Email
- r.wojciechowski@wp.eu
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Oddział Kliniczny Reumatologii
- Principal Investigator Name
- Piotr Wiland
- Principal Investigator Email
- pwiland1@gmail.com
- Contact Person Name
- Piotr Wiland
- Contact Person Email
- pwiland1@gmail.com
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Maria Misterska-Skóra
- Principal Investigator Email
- maria.misterska-skora@cmoporow.com
- Contact Person Name
- Maria Misterska-Skóra
- Contact Person Email
- maria.misterska-skora@cmoporow.com
- Site Name
- Etg Warszawa Sp. z o.o.
- Principal Investigator Name
- Anna Rowińska-Osuch
- Principal Investigator Email
- a.rowinskaosuch@etg-network.com
- Contact Person Name
- Anna Rowińska-Osuch
- Contact Person Email
- a.rowinskaosuch@etg-network.com
- Site Name
- K2J2 Sp. z o.o.
- Department Name
- Centrum Medyczne K2J2
- Principal Investigator Name
- Katarzyna Kamińska-Stachniak
- Principal Investigator Email
- k.kaminska-stachniak@k2j2.pl
- Contact Person Name
- Katarzyna Kamińska-Stachniak
- Contact Person Email
- k.kaminska-stachniak@k2j2.pl
- Site Name
- Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia PCM
- Principal Investigator Name
- Agata Wytyk-Nowak
- Principal Investigator Email
- wytyk@twojaprzychodnia.com
- Contact Person Name
- Agata Wytyk-Nowak
- Contact Person Email
- wytyk@twojaprzychodnia.com
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- FutureMeds Warszawa Centrum
- Principal Investigator Name
- Izabella Gładysz
- Principal Investigator Email
- izabella.gladysz@futuremeds.com
- Contact Person Name
- Izabella Gładysz
- Contact Person Email
- izabella.gladysz@futuremeds.com
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Principal Investigator Name
- Magdalena Celińska-Löwenhoff
- Principal Investigator Email
- magdalena.lowenhoff@gmail.com
- Contact Person Name
- Magdalena Celińska-Löwenhoff
- Contact Person Email
- magdalena.lowenhoff@gmail.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS Centrum Medyczne Bydgoszcz
- Principal Investigator Name
- Katarzyna Kolossa
- Principal Investigator Email
- k.kolossa@naszlekarz.pl
- Contact Person Name
- Katarzyna Kolossa
- Contact Person Email
- k.kolossa@naszlekarz.pl
- Site Name
- Prywatna Praktyka Lekarska Prof. dr hab. med Pawel Hrycaj
- Principal Investigator Name
- Paweł Hrycaj
- Principal Investigator Email
- pawel.hrycaj@gmail.com
- Contact Person Name
- Paweł Hrycaj
- Contact Person Email
- pawel.hrycaj@gmail.com
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Maria Jaraczewska-Baumann
- Principal Investigator Email
- medi-consult@wp.pl
- Contact Person Name
- Maria Jaraczewska-Baumann
- Contact Person Email
- medi-consult@wp.pl
- Site Name
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
- Principal Investigator Name
- Agnieszka Bielewicz-Zielinska
- Principal Investigator Email
- a.bielewicz-zielinska@klinikabadawcza.pl
- Contact Person Name
- Agnieszka Bielewicz-Zielinska
- Contact Person Email
- a.bielewicz-zielinska@klinikabadawcza.pl
- Site Name
- Malopolskie Centrum Kliniczne
- Principal Investigator Name
- Ewa Zimmer-Satora
- Principal Investigator Email
- ezimersatora@mck-krakow.pl
- Contact Person Name
- Ewa Zimmer-Satora
- Contact Person Email
- ezimersatora@mck-krakow.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 98
- Number Of Sites
- 11
- Number Of Participants
- 73
Sites
- Site Name
- Fundacio Hospital De L'Esperit Sant
- Department Name
- Internal Medicine
- Principal Investigator Name
- Gloria De La Red Bellvis
- Principal Investigator Email
- gred@fhes.cat
- Contact Person Name
- Gloria De La Red Bellvis
- Contact Person Email
- gred@fhes.cat
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Rheumatology
- Principal Investigator Name
- Lola Fernandez de la Fuente Burson
- Principal Investigator Email
- lolaffb@gmail.com
- Contact Person Name
- Lola Fernandez de la Fuente Burson
- Contact Person Email
- lolaffb@gmail.com
- Site Name
- Hospital Universitario Basurto
- Department Name
- Rheumatology
- Principal Investigator Name
- María Esther Ruiz Lucea
- Principal Investigator Email
- MARIAESTHER.RUIZLUCEA@osakidetza.eus
- Contact Person Name
- María Esther Ruiz Lucea
- Contact Person Email
- MARIAESTHER.RUIZLUCEA@osakidetza.eus
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- Principal Investigator Name
- Sara Manrique Arija
- Principal Investigator Email
- sara.manrique.sspa@juntadeandalucia.es
- Contact Person Name
- Sara Manrique Arija
- Contact Person Email
- sara.manrique.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Rheumatology
- Principal Investigator Name
- Rafaela Ortega Castro
- Principal Investigator Email
- mrafaela.ortega.sspa@juntadeandalucia.es
- Contact Person Name
- Rafaela Ortega Castro
- Contact Person Email
- mrafaela.ortega.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Rheumatology
- Principal Investigator Name
- Rosalia Martinez Perez
- Principal Investigator Email
- rosalia.martinez.perez@gmail.com
- Contact Person Name
- Rosalia Martinez Perez
- Contact Person Email
- rosalia.martinez.perez@gmail.com
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Rheumatology
- Principal Investigator Name
- Federico Diaz-Gonzalez
- Principal Investigator Email
- federico.diaz.gonzalez@gmail.com
- Contact Person Name
- Federico Diaz-Gonzalez
- Contact Person Email
- federico.diaz.gonzalez@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Rheumatology
- Principal Investigator Name
- Sheila Melchor Díaz
- Principal Investigator Email
- sheila.melchor@salud.madrid.org
- Contact Person Name
- Sheila Melchor Díaz
- Contact Person Email
- sheila.melchor@salud.madrid.org
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Rheumatology
- Principal Investigator Name
- María Teresa Navío Marco
- Principal Investigator Email
- mteresa.navio@salud.madrid.org
- Contact Person Name
- María Teresa Navío Marco
- Contact Person Email
- mteresa.navio@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Rheumatology
- Principal Investigator Name
- Francisco Javier Blanco Garcia
- Principal Investigator Email
- fblagar@sergas.es
- Contact Person Name
- Francisco Javier Blanco Garcia
- Contact Person Email
- fblagar@sergas.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Rheumatology
- Principal Investigator Name
- Belen Serrano
- Principal Investigator Email
- bserranob@salud.madrid.org
- Contact Person Name
- Belen Serrano
- Contact Person Email
- bserranob@salud.madrid.org
Greece
- Earliest CTIS Part Ii Submission Date
- 06-02-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 82
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Athens Naval Hospital
- Department Name
- Rheumatology Clinic
- Principal Investigator Name
- Gkikas Katsifis
- Principal Investigator Email
- katsifisg@yahoo.gr
- Contact Person Name
- Gkikas Katsifis
- Contact Person Email
- katsifisg@yahoo.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- Rheumatology & Clinical Immunology
- Principal Investigator Name
- Christina Katsiari
- Principal Investigator Email
- cgk2005@gmail.com
- Contact Person Name
- Christina Katsiari
- Contact Person Email
- cgk2005@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Pathophysiology
- Principal Investigator Name
- Andreas Goules
- Principal Investigator Email
- agoules@med.uoa.gr
- Contact Person Name
- Andreas Goules
- Contact Person Email
- agoules@med.uoa.gr
- Site Name
- Euromedica Kyanous Stavros
- Department Name
- Rheumatology
- Principal Investigator Name
- Loukas Settas
- Principal Investigator Email
- loukassettas@gmail.com
- Contact Person Name
- Loukas Settas
- Contact Person Email
- loukassettas@gmail.com
- Site Name
- Olympion Therapeftirio General Clinic Of Patras S.A.
- Department Name
- Rheumatology
- Principal Investigator Name
- Andreas Bounas
- Principal Investigator Email
- andreasgbounas@gmail.com
- Contact Person Name
- Andreas Bounas
- Contact Person Email
- andreasgbounas@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 25-03-2025
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 41
- Number Of Sites
- 11
- Number Of Participants
- 39
Sites
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Reumatologia
- Principal Investigator Name
- Lucia Dardani
- Principal Investigator Email
- lucia.dardani@ausl.re.it
- Contact Person Name
- Lucia Dardani
- Contact Person Email
- lucia.dardani@ausl.re.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- RCCS-Reumatologia
- Principal Investigator Name
- Maria Antonietta D’Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.i
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.i
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UO Reumatologia
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Reumatologia
- Principal Investigator Name
- Luca Quartuccio
- Principal Investigator Email
- luca.quartuccio@asufc.sanita.fvg.it
- Contact Person Name
- Luca Quartuccio
- Contact Person Email
- luca.quartuccio@asufc.sanita.fvg.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Dipartimento di Medicina, Unità di Reumatologia
- Principal Investigator Name
- Luca Idolazzi
- Principal Investigator Email
- luca.idolazzi@univr.it
- Contact Person Name
- Luca Idolazzi
- Contact Person Email
- luca.idolazzi@univr.it
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico
- Department Name
- Immunoreumatologia
- Principal Investigator Name
- Roberto Giacomelli
- Principal Investigator Email
- r.giacomelli@unicampus.it
- Contact Person Name
- Roberto Giacomelli
- Contact Person Email
- r.giacomelli@unicampus.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Maggiore Policlinico Malattie Autoimmuni Sistemiche
- Principal Investigator Name
- Lorenzo Beretta
- Principal Investigator Email
- lorenzo.beretta@policlinico.mi.it
- Contact Person Name
- Lorenzo Beretta
- Contact Person Email
- lorenzo.beretta@policlinico.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Medicina Interna Interdisciplinare
- Principal Investigator Name
- Elena Silvestri
- Principal Investigator Email
- elena.silvestri@unifi.it
- Contact Person Name
- Elena Silvestri
- Contact Person Email
- elena.silvestri@unifi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- PO Santa Chiara-UO Reumatologia
- Principal Investigator Name
- Chiara Baldini
- Principal Investigator Email
- chiara.baldini74@gmail.com
- Contact Person Name
- Chiara Baldini
- Contact Person Email
- chiara.baldini74@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- S.C. Reumatologia
- Principal Investigator Name
- Simone Parisi
- Principal Investigator Email
- sparisi@cittadellasalute.to.it
- Contact Person Name
- Simone Parisi
- Contact Person Email
- sparisi@cittadellasalute.to.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania (duplicate)
- Department Name
- UO Reumatologia
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Contract Research Organization, Clinical Database Management, Pharmacovigilance services
- Name
- Parexel International Services India Private Limited
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Throboembolic event adjudication","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Contract Research Organization, Clinical Database Management, Pharmacovigilance services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Travel vendor, Make travel arrangements and/or provide Reimbursement services for approved Patient paid expenses for ground transportation and meal during travel to/from study visits and patient stipends for US and UK","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"IP Management and Depot","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA, ePRO and Patient Dairy","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Dazodalibep
- Active Substance
- DAZODALIBEP
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
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