Clinical trial • Phase II • Gastroenterology
Humanised IgG4 kappa monoclonal antibody against CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 and CXCL8 for Ulcerative colitis
Phase II trial of Humanised IgG4 kappa monoclonal antibody against CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 and CXCL8 for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-10-2024
- First CTIS Authorization Date
- 10-02-2025
Trial design
Randomised, mirikizumab (comparator; solution for injection / solution for infusion) — dose/schedule: not specified; placebo for ly3074828 sc injection, 1ml prefilled syringe — dose/schedule: not specified; 0.9% sodium chloride — dose/schedule: not specified.-controlled, adaptive Phase II trial in Denmark, Belgium, Spain and others.
- Randomised
- Yes
- Comparator
- Mirikizumab (comparator; solution for injection / solution for infusion) — dose/schedule: Not specified; Placebo for LY3074828 SC Injection, 1mL Prefilled Syringe — dose/schedule: Not specified; 0.9% sodium chloride — dose/schedule: Not specified.
- Adaptive
- True, adaptive dose‑ranging design (study described as "An Adaptive, Dose-Ranging, Phase 2 Study" with staged evaluation and dose-ranging elements).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 43
Eligibility
Recruits 43 isVulnerablePopulationSelected is true. Specific subject information and informed consent forms are provided (multiple Main ICF A/B/C and Stage-1 ICFs) as well as dedicated 'Pregnant Partner' ICFs and pharmacogenetic addenda (documents listed for multiple countries). Consent is handled via ICF documents (including country/language-specific ICFs); no paediatric assent process is described in the Part I/II data..
- Vulnerable Population
- isVulnerablePopulationSelected is true. Specific subject information and informed consent forms are provided (multiple Main ICF A/B/C and Stage-1 ICFs) as well as dedicated 'Pregnant Partner' ICFs and pharmacogenetic addenda (documents listed for multiple countries). Consent is handled via ICF documents (including country/language-specific ICFs); no paediatric assent process is described in the Part I/II data.
Inclusion criteria
- {"criterion_text":"- 1. Have had an established diagnosis of UC of ≥3 months in duration before baseline."}
- {"criterion_text":"- 2. Have moderately to severely active UC as assessed by the UC disease activity score."}
- {"criterion_text":"- 3. Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators)."}
- {"criterion_text":"- 4. Are on a stable dose of certain oral UC medications (including corticosteroids)."}
- {"criterion_text":"- 5. Must meet contraception requirements."}
Exclusion criteria
- {"criterion_text":"- 1. Have received anti-IL-23p19 or anti-IL-12p40 antibodies in the past."}
- {"criterion_text":"- 2. Have experienced a thrombotic event within 24 weeks before baseline."}
- {"criterion_text":"- 3. Have a current diagnosis of Crohn’s Disease or certain other inflammatory gastrointestinal diseases."}
- {"criterion_text":"- 4. Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study."}
- {"criterion_text":"- 5. Have a history of certain adenomas, dysplasia’s, or malignancies."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants who achieve clinical remission at Week 12","definition_or_measurement_approach":"Proportion of participants achieving clinical remission at Week 12, assessed using the UC disease activity score (clinical remission at Week 12)."}
Recruitment
- Digital Remote Recruitment
- True, includes social media ads, online landing pages, keyword-search campaigns, online pre-screening questionnaires, and telephone pre-consent via Scout Clinical; eConsent/eCOA platforms (Signant Health) are listed as vendors.
- Planned Sample Size
- 43
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent is obtained from adult participants via country- and language-specific Main ICF documents (Main ICF A/B/C, Stage-1 ICFs). Additional ICFs/addenda available for pharmacogenetic testing and for pregnant partners. Pre-ICF telephone data consent (Scout Clinical) and eConsent/eCOA vendor (Signant Health) are used. ICFs are provided in multiple languages (examples in the documents: English, Spanish, French, German, Italian, Dutch, Polish, Hungarian, Czech, Greek, Croatian, Latvian, Romanian, Danish and localized language versions per country). No assent process for minors is described.
Methods
- Social media advertising (assets: 1080x1080 and 1200x628 images) — country/language-specific social media materials provided (e.g. ES, DE, PL, LV, FR, IT, CZ, HR, HU, IE etc).
- Dedicated landing pages / US Landing Page (country-specific versions).
- Doctor-to-patient letters (country/language-specific).
- Doctor-to-doctor letters / GP letters (country/language-specific).
- Patient recruitment brochures and flipcharts (country/language-specific).
- Keyword-search campaign materials (search advertising).
- Pre-screening questionnaires (SSPS) and pre-screening materials.
- Pre-ICF telephone contact and data consent via Scout Clinical (Scout Pre-ICF Telephone Data Consent forms present).
- Appointment/thank-you cards and site-level recruitment materials.
- Local site outreach (site-specific materials and doctor/GP letters) and central patient recruitment support via third parties (e.g., Inato listed for patient recruitment).
Geography
- Total Number Of Sites
- 112
- Total Number Of Participants
- 605
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Gastroenterologisk afdeling
- Principal Investigator Name
- Jakob Wium Bjerrum
- Principal Investigator Email
- jacob.wium.bjerrum@regionh.dk
- Contact Person Name
- Jakob Wium Bjerrum
- Contact Person Email
- jacob.wium.bjerrum@regionh.dk
- Site Name
- Region Hovedstaden
- Department Name
- Digestive Disease Center
- Principal Investigator Name
- Martin Eefsen
- Principal Investigator Email
- Martin.eefsen@regionh.dk
- Contact Person Name
- Martin Eefsen
- Contact Person Email
- Martin.eefsen@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
- Department Name
- Gastro-enterelogy
- Principal Investigator Name
- Gaël Englebert
- Principal Investigator Email
- genglebe@chu-tivoli.be
- Contact Person Name
- Gaël Englebert
- Contact Person Email
- genglebe@chu-tivoli.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Gastro-enterelogy
- Principal Investigator Name
- Jean-François Rahier
- Principal Investigator Email
- jean-francois.rahier@chuuclnamur.uclouvain.be
- Contact Person Name
- Jean-François Rahier
- Contact Person Email
- jean-francois.rahier@chuuclnamur.uclouvain.be
Spain
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 11-02-2025
- Processing Time Days
- 83
- Number Of Sites
- 9
- Number Of Participants
- 50
Sites
- Site Name
- Centro Medico Teknon-Grupo Quironsalud
- Department Name
- Gastroenterology
- Principal Investigator Name
- Miquel Sans Cuffi
- Principal Investigator Email
- miqul.sans@quironsalud.es
- Contact Person Name
- Miquel Sans Cuffi
- Contact Person Email
- miqul.sans@quironsalud.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Gastroenterology
- Principal Investigator Name
- Marisa Iborra Colomino
- Principal Investigator Email
- marisaiborra@hotmail.com
- Contact Person Name
- Marisa Iborra Colomino
- Contact Person Email
- marisaiborra@hotmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Gastroenterology
- Principal Investigator Name
- Daniel Ceballos Santos
- Principal Investigator Email
- dcebsan@gobiernodecanarias.org
- Contact Person Name
- Daniel Ceballos Santos
- Contact Person Email
- dcebsan@gobiernodecanarias.org
- Site Name
- Hospital General De Tomelloso
- Department Name
- Gastroenterology
- Principal Investigator Name
- Alfredo Lucendo Villarin
- Principal Investigator Email
- ajlucendo@hotmail.com
- Contact Person Name
- Alfredo Lucendo Villarin
- Contact Person Email
- ajlucendo@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Gastroenterology
- Principal Investigator Name
- Federico Argüelles-Arias
- Principal Investigator Email
- farguelles@telefonica.net
- Contact Person Name
- Federico Argüelles-Arias
- Contact Person Email
- farguelles@telefonica.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Gastroenterology
- Principal Investigator Name
- Maria Dolores Martín Arranz
- Principal Investigator Email
- mmartinarranz@salud.madrid.org
- Contact Person Name
- Maria Dolores Martín Arranz
- Contact Person Email
- mmartinarranz@salud.madrid.org
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Digestive
- Principal Investigator Name
- Eva Maria Iglesias Flores
- Principal Investigator Email
- evaiflores@gmail.com
- Contact Person Name
- Eva Maria Iglesias Flores
- Contact Person Email
- evaiflores@gmail.com
- Site Name
- Hospital Universitario Juan Ramon Jimenez
- Department Name
- Digestivo
- Principal Investigator Name
- Hector Pallares
- Principal Investigator Email
- hpallaresmanrique@gmail.com
- Contact Person Name
- Hector Pallares
- Contact Person Email
- hpallaresmanrique@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Gastroenterology
- Principal Investigator Name
- Manuel Francisco Barreiro De Acosta
- Principal Investigator Email
- manuel.barreiro.de.acosta@sergas.es
- Contact Person Name
- Manuel Francisco Barreiro De Acosta
- Contact Person Email
- manuel.barreiro.de.acosta@sergas.es
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 11-02-2025
- Processing Time Days
- 25
- Number Of Sites
- 4
- Number Of Participants
- 30
Sites
- Site Name
- SurGal Clinic s.r.o.
- Department Name
- Endoskopické centrum
- Principal Investigator Name
- Jan Ulbrych
- Principal Investigator Email
- Ulbrych.jan@surgalclinic.cz
- Contact Person Name
- Jan Ulbrych
- Contact Person Email
- Ulbrych.jan@surgalclinic.cz
- Site Name
- Krajska Nemocnice T Bati a.s.
- Department Name
- Interní klinika
- Principal Investigator Name
- Vladimír Kojecký
- Principal Investigator Email
- kojecky@bnzlin.cz
- Contact Person Name
- Vladimír Kojecký
- Contact Person Email
- kojecky@bnzlin.cz
- Site Name
- Nemocnice Slany
- Department Name
- Interní klinika Gastroenterologie
- Principal Investigator Name
- Martin Peterka
- Principal Investigator Email
- peterka.studie@seznam.cz
- Contact Person Name
- Martin Peterka
- Contact Person Email
- peterka.studie@seznam.cz
- Site Name
- Vojenska Nemocnice Brno
- Department Name
- Interní oddělení
- Principal Investigator Name
- David Štěpek
- Principal Investigator Email
- dstepek@vnbrno.cz
- Contact Person Name
- David Štěpek
- Contact Person Email
- dstepek@vnbrno.cz
Croatia
- Earliest CTIS Part Ii Submission Date
- 27-01-2025
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 21
- Number Of Sites
- 6
- Number Of Participants
- 28
Sites
- Site Name
- Specijalna Bolnica Medico
- Principal Investigator Name
- Boris Brozovic
- Principal Investigator Email
- borizbrozovic@yahoo.com
- Contact Person Name
- Boris Brozovic
- Contact Person Email
- borizbrozovic@yahoo.com
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Zeljko Krznaric
- Principal Investigator Email
- Zeljko.krznaric1@zg.t-com.hr
- Contact Person Name
- Zeljko Krznaric
- Contact Person Email
- Zeljko.krznaric1@zg.t-com.hr
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Dominik Kralj
- Principal Investigator Email
- info@solmed-clinic.com
- Contact Person Name
- Dominik Kralj
- Contact Person Email
- info@solmed-clinic.com
- Site Name
- Poliklinika Borzan d.o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Vladimir Borzan
- Principal Investigator Email
- Info@poliklinika-borzan.hr
- Contact Person Name
- Vladimir Borzan
- Contact Person Email
- Info@poliklinika-borzan.hr
- Site Name
- Opca Bolnica Dr. Andelko Visic Bjelovar
- Department Name
- Gastroenterology and Pulmology
- Principal Investigator Name
- Marinko Lukic
- Principal Investigator Email
- interna@obbj.hr
- Contact Person Name
- Marinko Lukic
- Contact Person Email
- interna@obbj.hr
- Site Name
- General Hospital Dr. Josip Bencevic
- Department Name
- Internal Medicine
- Principal Investigator Name
- Blazenka Miskic
- Principal Investigator Email
- interna@bolnicasb.hr
- Contact Person Name
- Blazenka Miskic
- Contact Person Email
- interna@bolnicasb.hr
Latvia
- Earliest CTIS Part Ii Submission Date
- 07-02-2025
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 5
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Veselibas Centrs 4 SIA
- Principal Investigator Name
- Alda Bumbure
- Principal Investigator Email
- aldabumbure@inbox.lv
- Contact Person Name
- Alda Bumbure
- Contact Person Email
- aldabumbure@inbox.lv
- Site Name
- Liepajas Regionala Slimnica SIA
- Principal Investigator Name
- Linda Erne
- Principal Investigator Email
- liepaajaa@inbox.lv
- Contact Person Name
- Linda Erne
- Contact Person Email
- liepaajaa@inbox.lv
- Site Name
- Pauls Stradins Clinical University Hospital
- Principal Investigator Name
- Aldis Pukitis
- Principal Investigator Email
- pukitis@latnet.lv
- Contact Person Name
- Aldis Pukitis
- Contact Person Email
- pukitis@latnet.lv
Greece
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 11-02-2025
- Processing Time Days
- 105
- Number Of Sites
- 7
- Number Of Participants
- 36
Sites
- Site Name
- Hippokration Hospital
- Department Name
- Hepatogastroenterology Unit
- Principal Investigator Name
- Spilios Manolakopoulos
- Principal Investigator Email
- smanolak@med.uoa.gr
- Contact Person Name
- Spilios Manolakopoulos
- Contact Person Email
- smanolak@med.uoa.gr
- Site Name
- Evangelismos S.A.
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Nikolaos Viazis
- Principal Investigator Email
- nikos.viazis@gmail.com
- Contact Person Name
- Nikolaos Viazis
- Contact Person Email
- nikos.viazis@gmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Academic Department of Internal Medicine, Gastroenterology Unit
- Principal Investigator Name
- Georgios (Giorgos) Bamias
- Principal Investigator Email
- gbamias@gmail.com
- Contact Person Name
- Georgios (Giorgos) Bamias
- Contact Person Email
- gbamias@gmail.com
- Site Name
- General Oncological Hospital Of Kifissia Agioi Anargyroi
- Department Name
- Endoscopy Unit
- Principal Investigator Name
- Athanasia Tasovasili
- Principal Investigator Email
- atasovasili@hotmail.com
- Contact Person Name
- Athanasia Tasovasili
- Contact Person Email
- atasovasili@hotmail.com
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Gastroenterology clinic and endoscopic unit
- Principal Investigator Name
- Dimitrios Christodoulou
- Principal Investigator Email
- dchristodoulou@gmail.com
- Contact Person Name
- Dimitrios Christodoulou
- Contact Person Email
- dchristodoulou@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Ioannis Koutroubakis
- Principal Investigator Email
- researchprot@pagni.gr
- Contact Person Name
- Ioannis Koutroubakis
- Contact Person Email
- researchprot@pagni.gr
- Site Name
- Alexandra Hospital
- Department Name
- Hepato-Gastroenterology Department
- Principal Investigator Name
- Spyridon Michopoulos
- Principal Investigator Email
- michosp5@gmail.com
- Contact Person Name
- Spyridon Michopoulos
- Contact Person Email
- michosp5@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 27-11-2024
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 82
- Number Of Sites
- 27
- Number Of Participants
- 93
Sites
- Site Name
- Pro Life Medica Sp. z o.o.
- Department Name
- ETG Zamość
- Principal Investigator Name
- Katarzyna Wójcik
- Principal Investigator Email
- k.wojcik@etg-network.com
- Contact Person Name
- Katarzyna Wójcik
- Contact Person Email
- k.wojcik@etg-network.com
- Site Name
- M2M Med. Sp. z o.o. Sp. j.
- Principal Investigator Name
- Magdalena Włoch-Targońska
- Principal Investigator Email
- m.wloch-targonska@m2m-badania.pl
- Contact Person Name
- Magdalena Włoch-Targońska
- Contact Person Email
- m.wloch-targonska@m2m-badania.pl
- Site Name
- EMC Instytut Medyczny S.A.
- Department Name
- EuroMediCare Przychodnia Specjalistyczna we Wrocławiu
- Principal Investigator Name
- Patryk Smoliński
- Principal Investigator Email
- psmolinski@poczta.onet.pl
- Contact Person Name
- Patryk Smoliński
- Contact Person Email
- psmolinski@poczta.onet.pl
- Site Name
- Eb Group Sp. z o.o.
- Department Name
- Centrum Zdrowia MDM
- Principal Investigator Name
- Marek Woynarowski
- Principal Investigator Email
- marek.woynarowski@czmdm.pl
- Contact Person Name
- Marek Woynarowski
- Contact Person Email
- marek.woynarowski@czmdm.pl
- Site Name
- Medical Concierge Centrum Medyczne
- Principal Investigator Name
- Jarosław Witkowski
- Principal Investigator Email
- pradziszewski@medicalconcierge.pl
- Contact Person Name
- Jarosław Witkowski
- Contact Person Email
- pradziszewski@medicalconcierge.pl
- Site Name
- Vitamed Galaj I Cichomski Sp. j.
- Principal Investigator Name
- Piotr Sikorski
- Principal Investigator Email
- p.sikorski@vitamed.info
- Contact Person Name
- Piotr Sikorski
- Contact Person Email
- p.sikorski@vitamed.info
- Site Name
- Amicare Sp. z o.o. S.K.
- Principal Investigator Name
- Rafał Drozda
- Principal Investigator Email
- r.drozda@amicare.pl
- Contact Person Name
- Rafał Drozda
- Contact Person Email
- r.drozda@amicare.pl
- Site Name
- Melita Medical Sp. z o.o.
- Department Name
- Centrum Medyczne Melita Medical
- Principal Investigator Name
- Jarosław Leszczyszyn
- Principal Investigator Email
- j.leszczyszyn@melitamedical.pl
- Contact Person Name
- Jarosław Leszczyszyn
- Contact Person Email
- j.leszczyszyn@melitamedical.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia SCM
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- scm@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- scm@twojaprzychodnia.com
- Site Name
- H-T.Centrum Medyczne Sp. z o.o. sp.k.
- Department Name
- H-T. Centrum Medyczne - Endoterapia
- Principal Investigator Name
- Tomasz Romańczyk
- Principal Investigator Email
- romanczyk@htcentrum.pl
- Contact Person Name
- Tomasz Romańczyk
- Contact Person Email
- romanczyk@htcentrum.pl
- Site Name
- Centrum Medyczne Med-Gastr Sp. z o.o.
- Principal Investigator Name
- Arkadiusz Mamos
- Principal Investigator Email
- arkadiusz.mamos@medgastr.pl
- Contact Person Name
- Arkadiusz Mamos
- Contact Person Email
- arkadiusz.mamos@medgastr.pl
- Site Name
- Endoskopia Sp. z o.o.
- Principal Investigator Name
- Marek Horyński
- Principal Investigator Email
- homar@mp.pl
- Contact Person Name
- Marek Horyński
- Contact Person Email
- homar@mp.pl
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- WIP Warsaw IBD Point Profesor Kierkuś
- Principal Investigator Name
- Jaroslaw Kierkuś
- Principal Investigator Email
- j.kierkus@med-net.pl
- Contact Person Name
- Jaroslaw Kierkuś
- Contact Person Email
- j.kierkus@med-net.pl
- Site Name
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
- Department Name
- Centrum Medyczne KERmed
- Principal Investigator Name
- Patryk Korga
- Principal Investigator Email
- patryk.korga@kermed.pl
- Contact Person Name
- Patryk Korga
- Contact Person Email
- patryk.korga@kermed.pl
- Site Name
- VISTAMED
- Principal Investigator Name
- Bernardeta Fryśna
- Principal Investigator Email
- b.frysna@vistamed.pl
- Contact Person Name
- Bernardeta Fryśna
- Contact Person Email
- b.frysna@vistamed.pl
- Site Name
- Manermed Sp. z o.o.
- Department Name
- Centrum Medyczne Medis
- Principal Investigator Name
- Maria Kłopocka
- Principal Investigator Email
- mariaklopocka@wp.pl
- Contact Person Name
- Maria Kłopocka
- Contact Person Email
- mariaklopocka@wp.pl
- Site Name
- Twoja Przychodnia Opolskie Centrum Medyczne
- Principal Investigator Name
- Marzena Kwinto
- Principal Investigator Email
- mkwinto@opolemed.com
- Contact Person Name
- Marzena Kwinto
- Contact Person Email
- mkwinto@opolemed.com
- Site Name
- Medrise Sp. z o.o.
- Principal Investigator Name
- Wit Danilkiewicz
- Principal Investigator Email
- wdanilk@gmail.com
- Contact Person Name
- Wit Danilkiewicz
- Contact Person Email
- wdanilk@gmail.com
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Principal Investigator Name
- Monika Augustyn
- Principal Investigator Email
- amonika@interia.pl
- Contact Person Name
- Monika Augustyn
- Contact Person Email
- amonika@interia.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Radoslaw Kempiński
- Principal Investigator Email
- radoslaw.kempinski@cmoporow.com
- Contact Person Name
- Radoslaw Kempiński
- Contact Person Email
- radoslaw.kempinski@cmoporow.com
- Site Name
- Ip Clinic Sp. z o.o.
- Principal Investigator Name
- Cezary Rudnicki
- Principal Investigator Email
- cezary.rudnicki@ipclinic.pl
- Contact Person Name
- Cezary Rudnicki
- Contact Person Email
- cezary.rudnicki@ipclinic.pl
- Site Name
- Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
- Principal Investigator Name
- Zbigniew Wylegała
- Principal Investigator Email
- zbigniew.wylegala@tmedicenter.com
- Contact Person Name
- Zbigniew Wylegała
- Contact Person Email
- zbigniew.wylegala@tmedicenter.com
- Site Name
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
- Principal Investigator Name
- Dorota Waśko-Czopnik
- Principal Investigator Email
- dorota.czopnik@migre.pl
- Contact Person Name
- Dorota Waśko-Czopnik
- Contact Person Email
- dorota.czopnik@migre.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia Poznań
- Principal Investigator Name
- Magdalena Andrzejewska
- Principal Investigator Email
- magdalena.andrzejewska@pratia.com
- Contact Person Name
- Magdalena Andrzejewska
- Contact Person Email
- magdalena.andrzejewska@pratia.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 27-11-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 78
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- University Of Szeged
- Department Name
- Belgyógyászati Klinika
- Principal Investigator Name
- Klaudia FARKAS
- Principal Investigator Email
- farkas.klaudia@gmail.com
- Contact Person Name
- Klaudia FARKAS
- Contact Person Email
- farkas.klaudia@gmail.com
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- I.Sz. Belgyógyászati Osztály
- Principal Investigator Name
- Roland FEJES
- Principal Investigator Email
- rfejes@mail.fmkorhaz.hu
- Contact Person Name
- Roland FEJES
- Contact Person Email
- rfejes@mail.fmkorhaz.hu
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- Gábor TÓTH
- Principal Investigator Email
- medicatorbt@gmail.com
- Contact Person Name
- Gábor TÓTH
- Contact Person Email
- medicatorbt@gmail.com
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Róbert SIKE
- Principal Investigator Email
- sike.endoexpert@gmail.com
- Contact Person Name
- Róbert SIKE
- Contact Person Email
- sike.endoexpert@gmail.com
- Site Name
- Clinexpert Gyoengyoes Kft.
- Principal Investigator Name
- Gyula HORVÁT
- Principal Investigator Email
- horvatgyula@gmail.com
- Contact Person Name
- Gyula HORVÁT
- Contact Person Email
- horvatgyula@gmail.com
- Site Name
- Semmelweis Egyetem
- Department Name
- II.Sz. Belgyógyászati Klinika
- Principal Investigator Name
- Zsolt TULASSAY
- Principal Investigator Email
- tulassay.zsolt@semelweis.hu
- Contact Person Name
- Zsolt TULASSAY
- Contact Person Email
- tulassay.zsolt@semelweis.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 29
- Number Of Sites
- 13
- Number Of Participants
- 86
Sites
- Site Name
- Magen-Darm-Zentrum Remscheid
- Principal Investigator Name
- Eric Jörgensen
- Principal Investigator Email
- ericjoergensen@me.com
- Contact Person Name
- Eric Jörgensen
- Contact Person Email
- ericjoergensen@me.com
- Site Name
- Studiengesellschaft BSF UG (haftungsbeschraenkt)
- Principal Investigator Name
- Lars Fechner
- Principal Investigator Email
- larsfechner1@icloud.com
- Contact Person Name
- Lars Fechner
- Contact Person Email
- larsfechner1@icloud.com
- Site Name
- Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K.
- Principal Investigator Name
- Stefanie Howaldt
- Principal Investigator Email
- howaldt@hafced.de
- Contact Person Name
- Stefanie Howaldt
- Contact Person Email
- howaldt@hafced.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
- Principal Investigator Name
- Michael Sigal
- Principal Investigator Email
- michael.sigal@charite.de
- Contact Person Name
- Michael Sigal
- Contact Person Email
- michael.sigal@charite.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II
- Principal Investigator Name
- Matthias Treiber
- Principal Investigator Email
- Matthias.Treiber@mri.tum.de
- Contact Person Name
- Matthias Treiber
- Contact Person Email
- Matthias.Treiber@mri.tum.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- III. Medizinische Klinik
- Principal Investigator Name
- Elisabeth Schnoy
- Principal Investigator Email
- elisabeth.schnoy@uk-augsburg.de
- Contact Person Name
- Elisabeth Schnoy
- Contact Person Email
- elisabeth.schnoy@uk-augsburg.de
- Site Name
- Universitaetsklinikum Brandenburg an der Havel GmbH
- Department Name
- Zentrum für Innere Medizin II Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endoskopie
- Principal Investigator Name
- Stefan Lüth
- Principal Investigator Email
- s.lueth@klinikum-brandenburg.de
- Contact Person Name
- Stefan Lüth
- Contact Person Email
- s.lueth@klinikum-brandenburg.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik 1
- Principal Investigator Name
- Irina Blumenstein
- Principal Investigator Email
- Blumenstein@em.uni-frankfurt.de
- Contact Person Name
- Irina Blumenstein
- Contact Person Email
- Blumenstein@em.uni-frankfurt.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
- Principal Investigator Name
- Ursula Seidler
- Principal Investigator Email
- seidler.ursula@mh-hannover.de
- Contact Person Name
- Ursula Seidler
- Contact Person Email
- seidler.ursula@mh-hannover.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- jochen.klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- jochen.klaus@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Allgemeine Innere Medizin I Medizinische Klinik
- Principal Investigator Name
- Stefan Schreiber
- Principal Investigator Email
- s.schreiber@mucosa.de
- Contact Person Name
- Stefan Schreiber
- Contact Person Email
- s.schreiber@mucosa.de
- Site Name
- CED Studien UG (haftungsbeschraenkt)
- Department Name
- Interdisziplinäres Crohn Colitis Centrum Rhein-Main
- Principal Investigator Name
- Jürgen Stein
- Principal Investigator Email
- j.stein@em.uni-frankfurt.de
- Contact Person Name
- Jürgen Stein
- Contact Person Email
- j.stein@em.uni-frankfurt.de
- Site Name
- Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH
- Department Name
- MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbH
- Principal Investigator Name
- Wolfgang Nitz
- Principal Investigator Email
- wolfgang.nitz@sana.de
- Contact Person Name
- Wolfgang Nitz
- Contact Person Email
- wolfgang.nitz@sana.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 06-02-2025
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Beaumont Hospital
- Department Name
- Gastroenterology
- Principal Investigator Name
- Aoibhlinn Mary O’Toole
- Principal Investigator Email
- aoibhlinnmaryotoole@beaumont.ie
- Contact Person Name
- Aoibhlinn Mary O’Toole
- Contact Person Email
- aoibhlinnmaryotoole@beaumont.ie
Romania
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 108
- Number Of Sites
- 7
- Number Of Participants
- 34
Sites
- Site Name
- Monza-Ares S.R.L.
- Department Name
- Gastroenterolgy Department
- Principal Investigator Name
- Theodor-Alexandru Voiosu
- Principal Investigator Email
- theodor.voiosu@gmail.com
- Contact Person Name
- Theodor-Alexandru Voiosu
- Contact Person Email
- theodor.voiosu@gmail.com
- Site Name
- Centrul De Gastroenterologie Dr. Goldis S.R.L.
- Department Name
- Gastroenterolgy
- Principal Investigator Name
- Eugen-Adrian Goldis
- Principal Investigator Email
- goldisadi@yahoo.com
- Contact Person Name
- Eugen-Adrian Goldis
- Contact Person Email
- goldisadi@yahoo.com
- Site Name
- Valahia Medical S.R.L.
- Department Name
- Gastroenterology
- Principal Investigator Name
- George Stancu
- Principal Investigator Email
- stancu.george@valahiamedical.ro
- Contact Person Name
- George Stancu
- Contact Person Email
- stancu.george@valahiamedical.ro
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Sectia Clinica Gastroenterologie
- Principal Investigator Name
- Sandica-Nicoleta Bucurica
- Principal Investigator Email
- bucuricasandy@yahoo.co
- Contact Person Name
- Sandica-Nicoleta Bucurica
- Contact Person Email
- bucuricasandy@yahoo.co
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Gastroenterology
- Principal Investigator Name
- Radu-Bogdan Mateescu
- Principal Investigator Email
- gastrostudii@gmail.com
- Contact Person Name
- Radu-Bogdan Mateescu
- Contact Person Email
- gastrostudii@gmail.com
- Site Name
- Spitalul Universitar De Urgenta Bucuresti
- Department Name
- Gastroenterology
- Principal Investigator Name
- Lucian Negreanu
- Principal Investigator Email
- negreanu_99@yahoo.com
- Contact Person Name
- Lucian Negreanu
- Contact Person Email
- negreanu_99@yahoo.com
- Site Name
- Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
- Department Name
- Gastroenterology
- Principal Investigator Name
- Cristina Pojoga
- Principal Investigator Email
- cristina.pojoga@yahoo.com
- Contact Person Name
- Cristina Pojoga
- Contact Person Email
- cristina.pojoga@yahoo.com
France
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 10-02-2025
- Processing Time Days
- 12
- Number Of Sites
- 6
- Number Of Participants
- 38
Sites
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Adrien Nicolau
- Principal Investigator Email
- nicolau.a@chu-nice.fr
- Contact Person Name
- Adrien Nicolau
- Contact Person Email
- nicolau.a@chu-nice.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Mathieu UZZAN
- Principal Investigator Email
- mathieu.uzzan@aphp.fr
- Contact Person Name
- Mathieu UZZAN
- Contact Person Email
- mathieu.uzzan@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Hepato-Gastroenterology Department
- Principal Investigator Name
- Guillaume Savoye
- Principal Investigator Email
- guillaume.savoye@chu-rouen.fr
- Contact Person Name
- Guillaume Savoye
- Contact Person Email
- guillaume.savoye@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Hepato-Gastroenterology Department
- Principal Investigator Name
- Clémence LOMBOIS
- Principal Investigator Email
- CLombois@chu-grenoble.fr
- Contact Person Name
- Clémence LOMBOIS
- Contact Person Email
- CLombois@chu-grenoble.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Hepato-Gastroenterology Department
- Principal Investigator Name
- Morgane Amil
- Principal Investigator Email
- morgane.amil@ght85.fr
- Contact Person Name
- Morgane Amil
- Contact Person Email
- morgane.amil@ght85.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Stéphane Nancey
- Principal Investigator Email
- stephane.nancey@chu-lyon.fr
- Contact Person Name
- Stéphane Nancey
- Contact Person Email
- stephane.nancey@chu-lyon.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 10-12-2024
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 66
- Number Of Sites
- 19
- Number Of Participants
- 124
Sites
- Site Name
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
- Department Name
- SSD Malattie Infiammatorie Croniche Intestinali - Centro di Riferimento per le MICI
- Principal Investigator Name
- Fernando Rizzello
- Principal Investigator Email
- fernando.rizzello@unibo.it
- Contact Person Name
- Fernando Rizzello
- Contact Person Email
- fernando.rizzello@unibo.it
- Site Name
- Azienda Ospedaliera Universitaria Gaetano Martino Messina
- Department Name
- UOC Gastroenterologia e malattie infiammatorie croniche intestinali
- Principal Investigator Name
- Walter Fries
- Principal Investigator Email
- fwalter@unime.it
- Contact Person Name
- Walter Fries
- Contact Person Email
- fwalter@unime.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- UOC Gastroenterologia Dipartimento di Medicina Interna e Terapia Medica
- Principal Investigator Name
- Antonio Di Sabatino
- Principal Investigator Email
- a.disabatino@smatteo.pv.it
- Contact Person Name
- Antonio Di Sabatino
- Contact Person Email
- a.disabatino@smatteo.pv.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Gastroenterologia ed Endoscopia digestiva
- Principal Investigator Name
- Silvio Danese
- Principal Investigator Email
- ibd.trials@hsr.it
- Contact Person Name
- Silvio Danese
- Contact Person Email
- ibd.trials@hsr.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Edoardo Savarino
- Principal Investigator Email
- edoardo.savarino@unipd.it
- Contact Person Name
- Edoardo Savarino
- Contact Person Email
- edoardo.savarino@unipd.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- S.C. Gastroenterology U.
- Principal Investigator Name
- Davide Giuseppe Ribaldone
- Principal Investigator Email
- avidegiuseppe.ribaldone@unito.it
- Contact Person Name
- Davide Giuseppe Ribaldone
- Contact Person Email
- avidegiuseppe.ribaldone@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- Unità di Gastroenterologia Dipartimento di Scienze Mediche e Salute Pubblica
- Principal Investigator Name
- Massimo Claudio Fantini
- Principal Investigator Email
- massimoc.fantini@unica.it
- Contact Person Name
- Massimo Claudio Fantini
- Contact Person Email
- massimoc.fantini@unica.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- U.O.C. Gastroenterologia
- Principal Investigator Name
- Giovanni Monteleone
- Principal Investigator Email
- gi.monteleone@med.uniroma2.it
- Contact Person Name
- Giovanni Monteleone
- Contact Person Email
- gi.monteleone@med.uniroma2.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- S.C. Medicina ad indirizzo Epatologico e Gastroenterologico
- Principal Investigator Name
- Luca Pastorelli
- Principal Investigator Email
- luca.pastorelli@unimi.it
- Contact Person Name
- Luca Pastorelli
- Contact Person Email
- luca.pastorelli@unimi.it
- Site Name
- Fondazione Poliambulanza
- Department Name
- Gastroenterology and Digestive Endoscopy Unit
- Principal Investigator Name
- Paola Cesaro
- Principal Investigator Email
- paola.cesaro@poliambulanza.it
- Contact Person Name
- Paola Cesaro
- Contact Person Email
- paola.cesaro@poliambulanza.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Chronic Infiammatory Bowel Diseases Unit
- Principal Investigator Name
- Alessandro Armuzzi
- Principal Investigator Email
- alessandro.armuzzi@hunimed.eu
- Contact Person Name
- Alessandro Armuzzi
- Contact Person Email
- alessandro.armuzzi@hunimed.eu
- Site Name
- Policlinico San Donato S.p.A.
- Department Name
- Unità di Gastroenterologia ed Endoscopia Digestiva
- Principal Investigator Name
- Vito Annese
- Principal Investigator Email
- Vito.Annese@grupposandonato.it
- Contact Person Name
- Vito Annese
- Contact Person Email
- Vito.Annese@grupposandonato.it
- Site Name
- Azienda Ospedaliera Universitaria Di Modena
- Department Name
- Struttura Complessa di Gastroenterologia ed Endoscopia Digestiva
- Principal Investigator Name
- Antonio Colecchia
- Principal Investigator Email
- antonio.colecchia@unimore.it
- Contact Person Name
- Antonio Colecchia
- Contact Person Email
- antonio.colecchia@unimore.it
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- UOC di Gastroenterologia ed Endoscopia Digestiva
- Principal Investigator Name
- Fabrizio Bossa
- Principal Investigator Email
- f.bossa@operapadrepio.it
- Contact Person Name
- Fabrizio Bossa
- Contact Person Email
- f.bossa@operapadrepio.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- SOD Gastroenterology
- Principal Investigator Name
- Francesca Rogai
- Principal Investigator Email
- rogaif@aou-careggi.toscana.it
- Contact Person Name
- Francesca Rogai
- Contact Person Email
- rogaif@aou-careggi.toscana.it
- Site Name
- Azienda Sanitaria Territoriale Di Pesaro E Urbino
- Department Name
- UOC Gastroenterologia e Endoscopia Digestiva
- Principal Investigator Name
- Antonella Scarcelli
- Principal Investigator Email
- antonella.scarcelli@ospedalimarchenord.it
- Contact Person Name
- Antonella Scarcelli
- Contact Person Email
- antonella.scarcelli@ospedalimarchenord.it
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Michele Cicala
- Principal Investigator Email
- m.cicala@policlinicocampus.it
- Contact Person Name
- Michele Cicala
- Contact Person Email
- m.cicala@policlinicocampus.it
- Site Name
- Azienda Ospedaliera S Giovanni Addolorata
- Department Name
- UOC Gastroenterologia Endoscopia Digestiva
- Principal Investigator Name
- Maria Giovanna Graziani
- Principal Investigator Email
- mg.graziani@virgilio.it
- Contact Person Name
- Maria Giovanna Graziani
- Contact Person Email
- mg.graziani@virgilio.it
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Pharmaceutical Product Development LLC (PPD)
- Responsibilities
- Testing, reporting, and sample management (i.e., receipt, storage, and shipment)
- Name
- PPD Global Central Labs / PPD Global Ltd. / PPD Development LP
- Responsibilities
- Central lab services, testing, sample management and various operational roles (multiple codes listed)
- Name
- Icon Development Solutions LLC
- Responsibilities
- PK Mirikizumab
- Name
- Pra International
- Responsibilities
- Reporting, and sample management (i.e., receipt, storage, and shipment)
Third parties
- {"country":"France","full_name":"Inato","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Testing, reporting, and sample management(i.e., receipt, storage, and shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Lab sciences assay for quantification of human plasma by Elisa","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"eCOA licensing and translation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Itinerary Management; Expense Reimbursement Management; Patient Payment Management","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Mirikizumab ADA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eurofins Pharma Bioanalytics Services US Inc.","duties_or_roles":"IL-8 testing, Eltrekibart ADA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"ECoA and eConsent vendor","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Testing, reporting, and sample management(i.e., receipt, storage, and shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"patient education and engagement materials","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"PK Mirikizumab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator meeting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Multiple operational duties (codes 1,12,5 etc) as listed","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pra International","duties_or_roles":"Reporting, and sample management(i.e., receipt, storage, and shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"Central Image Management","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Eltrekibart
- Active Substance
- Humanised IgG4 kappa monoclonal antibody against CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 and CXCL8
- Modality
- Monoclonal antibody
- Routes Of Administration
- Infusion
- Route
- Infusion
- Authorisation Status
- Authorised (prodAuthStatus: 1)
- Investigational Product Name
- Mirikizumab
- Active Substance
- Mirikizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Solution for injection (pre-filled syringe) and solution for infusion
- Route
- Injection / Infusion
- Authorisation Status
- Authorised (prodAuthStatus: 1)
- Investigational Product Name
- Placebo for LY3074828 SC Injection, 1mL Prefilled Syringe
- Modality
- Other
- Routes Of Administration
- SC injection (placebo)
- Route
- SC injection (placebo)
- Investigational Product Name
- 0.9% sodium chloride
- Modality
- Other
- Routes Of Administration
- Infusion (placebo for infusion)
- Route
- Infusion (placebo)
- Combination Treatment
- Yes
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