Clinical trial • Phase II • Gastroenterology
GS-1427 for Ulcerative colitis
Phase II trial of GS-1427 for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-03-2024
- First CTIS Authorization Date
- 22-07-2024
Trial design
Randomised, placebo tablets (ptm 25 mg, ptm 75 mg, ptm 100 mg) matching gs-1427 tablets (placebo arms listed as ptm 25 mg / 75 mg / 100 mg tablets).-controlled Phase II trial in Romania, Austria, Belgium and others.
- Randomised
- Yes
- Comparator
- Placebo tablets (PTM 25 mg, PTM 75 mg, PTM 100 mg) matching GS-1427 tablets (placebo arms listed as PTM 25 mg / 75 mg / 100 mg tablets).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 144
- Trial Duration For Participant
- 812
Eligibility
Recruits 144 isVulnerablePopulationSelected: true; subject information and consent forms are available for pregnant participants, pregnant partner, infant follow-up and scout/infant ICFs; multiple country-specific main ICFs are provided. (Documents listed include Main ICFs, Pregnant Participant ICFs, Pregnant Partner ICFs, Infant Follow-up ICFs and Scout ICFs in multiple languages.).
- Vulnerable Population
- isVulnerablePopulationSelected: true; subject information and consent forms are available for pregnant participants, pregnant partner, infant follow-up and scout/infant ICFs; multiple country-specific main ICFs are provided. (Documents listed include Main ICFs, Pregnant Participant ICFs, Pregnant Partner ICFs, Infant Follow-up ICFs and Scout ICFs in multiple languages.)
Inclusion criteria
- {"criterion_text":"- Participants have UC with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents."}
- {"criterion_text":"- Participants have UC with minimum disease extent of 15 cm from the anal verge."}
- {"criterion_text":"- Participants have moderately to severely active UC as determined by endoscopy occurring during screening with a total mMCS of 5 to 9 points, including a centrally read endoscopic subscore of at least 2."}
- {"criterion_text":"- Participants have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: Corticosteroids Immunomodulators: azathioprine, 6-mercaptopurine, or 6-thioguanine (see full inclusion criteria for details) Advanced therapy: have an inadequate response or loss of response or are intolerant to an advanced therapy (AT) for the treatment of UC: ○ Tumor necrosis factor-alpha (TNF-α) inhibitor: eg, infliximab, adalimumab, golimumab, or biosimilars ○ Interleukin-12/23 inhibitor: eg, Ustekinumab. Sphingosine 1-phosphate receptor modulator: eg, ozanimod ○ Janus kinase inhibitor: eg, tofacitinib, upadacitinib, filgotinib"}
- {"criterion_text":"- Participants have an inadequate response or loss of response or are intolerant to < 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action):"}
Exclusion criteria
- {"criterion_text":"- Have a current diagnosis of Crohn’s disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to causes such as an enteric pathogen, or lymphocytic or collagenous colitis."}
- {"criterion_text":"- Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization."}
- {"criterion_text":"- Have any history of exposure to vedolizumab or other integrin antagonists."}
- {"criterion_text":"- Have any history of stroke, seizure disorder, multiple sclerosis, neurodegenerative disease of brain (such as Parkinson’s disease, dementias), or brain tumor."}
- {"criterion_text":"- Have a positive progressive multifocal leukoencephalopathy subjective checklist at screening or at randomization prior to the administration of the first dose of study drug."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical response at Week 12 Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1.","definition_or_measurement_approach":"Clinical response at Week 12 defined as decrease from baseline in mMCS of ≥2 points and ≥30% reduction from baseline AND decrease in rectal bleeding subscore ≥1 from baseline or absolute rectal bleeding subscore 0 or 1; assessed at Week 12 (mMCS and rectal bleeding subscore; endoscopy and central reads for endoscopic subscores where applicable)."}
Secondary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events, serious adverse events, or deaths, and treatment-emergent laboratory abnormalities","definition_or_measurement_approach":"Safety/tolerability assessed as incidence of treatment-emergent AEs, SAEs, deaths and treatment-emergent laboratory abnormalities (standard AE/SAE reporting and lab assessments)."}
- {"endpoint_text":"- Clinical remission at Week 12","definition_or_measurement_approach":"Clinical remission defined (where provided for Week 52) as mMCS ≤ 2 with stool frequency subscore ≤1 not greater than baseline and rectal bleeding subscore of 0 and centrally-read endoscopic subscore ≤1; for Week 12 endpoint the study will use the corresponding Week 12 definition as per protocol."}
- {"endpoint_text":"- Clinical remission at Week 52 Clinical remission is defined as an mMCS of ≤ 2 points, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally-read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).","definition_or_measurement_approach":"Clinical remission at Week 52 defined explicitly as mMCS ≤2, SFS ≤1 and not greater than baseline, rectal bleeding subscore 0, and centrally-read endoscopic subscore ≤1 (with score of 1 modified to exclude friability)."}
- {"endpoint_text":"- Histologic-endoscopic mucosal improvement at Week 12 Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopic subscore of ≤ 1.","definition_or_measurement_approach":"Defined as Geboes score ≤3.1 and endoscopic subscore ≤1 at Week 12 (histology + endoscopy central reads)."}
- {"endpoint_text":"- Mucosal healing at Week 12 Mucosal healing is defined as a Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.","definition_or_measurement_approach":"Defined as Geboes score ≤2B.1 and endoscopic subscore ≤1 at Week 12."}
- {"endpoint_text":"- Endoscopic improvement at Week 12 Endoscopic improvement is defined as an endoscopic subscore ≤ 1.","definition_or_measurement_approach":"Endoscopic subscore ≤1 at Week 12 (central endoscopic read)."}
- {"endpoint_text":"- Partial mMCS remission at Week 52 Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.","definition_or_measurement_approach":"Partial mMCS remission at Week 52 defined as stool frequency subscore ≤1 and rectal bleeding subscore 0."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Asociatia Oncohelp
- Digital Remote Recruitment
- True, documents indicate use of eCOA (digital self-complete), eCOA instruments (EQ-5D-5L, IBDQ, UC-PRO-SS), subject devices/site tablets (provided by Signant Health), and Scout email/digital communications.
- Planned Sample Size
- 144
- Recruitment Window Months
- 43
- Consent Approach
- Adult participants provide informed consent via country-specific Main ICFs; multiple language ICFs available (English and country languages across France, Germany, Spain, Italy, Poland, Romania, Hungary, Czech, Belgium variants etc.). Separate ICFs exist for pregnant participants, pregnant partners, infant follow-up, reimbursement-and-travel, optional future research and Scout participants. Parent/guardian consent procedures are provided for infant follow-up (Infant Follow-up ICFs).
Methods
- Country-specific recruitment brochures and recruitment arrangements (multiple PDFs listed for each MSC e.g., Recruitment Brochure, Recruitment-Arrangements documents).
- GP letters (documents titled GP letter available for some countries).
- Scout outreach (Scout ICF, Scout email communications, Scout study brochure listed).
- Site-based recruitment (site contact lists and patient advocacy contact lists listed).
- Digital eCOA and electronic communications (eCOA instruments, digital self-complete forms and email communications referenced).
Geography
- Total Number Of Sites
- 55
- Total Number Of Participants
- 124
Romania
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 571
- Number Of Sites
- 11
- Number Of Participants
- 13
Sites
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Gastroenterology Department
- 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
- Institutul Clinic Fundeni
- Department Name
- Gastroenterology 2
- Principal Investigator Name
- Carmen Monica Preda
- Principal Investigator Email
- Preda_monicaa@yahoo.com
- Contact Person Name
- Carmen Monica Preda
- Contact Person Email
- Preda_monicaa@yahoo.com
- 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.com
- Contact Person Name
- Sandica-Nicoleta Bucurica
- Contact Person Email
- bucuricasandy@yahoo.com
- Site Name
- Gastromed S.R.L.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Florin-George Musat
- Principal Investigator Email
- florinmusat.trials@gmail.com
- Contact Person Name
- Florin-George Musat
- Contact Person Email
- florinmusat.trials@gmail.com
- Site Name
- Centrul Medical Medicum S.R.L.
- Department Name
- Gastroenterology
- 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 Medical Monza S.R.L.
- Department Name
- Gastroenterolgy Department
- Principal Investigator Name
- Iulia Simionov
- Principal Investigator Email
- dr_simionov@yahoo.com
- Contact Person Name
- Iulia Simionov
- Contact Person Email
- dr_simionov@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Vlad-Andrei Ichim
- Principal Investigator Email
- vlad.ichim.ext@arensiaem.com
- Contact Person Name
- Vlad-Andrei Ichim
- Contact Person Email
- vlad.ichim.ext@arensiaem.com
- Site Name
- Asociatia Oncohelp
- Department Name
- Gastroenterology
- Principal Investigator Name
- Razvan-Gheorghe Diaconescu
- Principal Investigator Email
- diaconescu_razvan@yahoo.com
- Contact Person Name
- Razvan-Gheorghe Diaconescu
- Contact Person Email
- diaconescu_razvan@yahoo.com
- Site Name
- Centrul De Gastroenterologie Dr. Goldis S.R.L.
- Department Name
- Gastroenterolgy Department
- 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
- Spital Judetean De Urgenta Satu Mare
- Department Name
- Sectia Gastroenterologie
- Principal Investigator Name
- Bogdan-Calin Pintea
- Principal Investigator Email
- dr.bogdan.pintea@gmail.com
- Contact Person Name
- Bogdan-Calin Pintea
- Contact Person Email
- dr.bogdan.pintea@gmail.com
- Site Name
- Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
- Department Name
- Sectia Clinica Gastroenterologie I
- Principal Investigator Name
- Cristina Pojoga
- Principal Investigator Email
- cristinapojoga@yahoo.com
- Contact Person Name
- Cristina Pojoga
- Contact Person Email
- cristinapojoga@yahoo.com
Austria
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 496
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
- Department Name
- University Clinic for Internal Medicine I
- Principal Investigator Name
- Sonja Heeren
- Principal Investigator Email
- s.heeren@salk.at
- Contact Person Name
- Sonja Heeren
- Contact Person Email
- s.heeren@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine III Division Gastroenterology and Hepatology
- Principal Investigator Name
- Walter Reinisch
- Principal Investigator Email
- walter.reinisch@meduniwien.ac.at
- Contact Person Name
- Walter Reinisch
- Contact Person Email
- walter.reinisch@meduniwien.ac.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- University Clinic for Internal Medicine I
- Principal Investigator Name
- Robert Koch
- Principal Investigator Email
- robert.koch@i-med.ac.at
- Contact Person Name
- Robert Koch
- Contact Person Email
- robert.koch@i-med.ac.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 497
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Gastroenterology
- Principal Investigator Name
- Wouter Van Moerkercke
- Principal Investigator Email
- wouter.vanmoerkercke@azgroeninge.be
- Contact Person Name
- Wouter Van Moerkercke
- Contact Person Email
- wouter.vanmoerkercke@azgroeninge.be
- Site Name
- Vitaz
- Department Name
- Gastroenterology
- Principal Investigator Name
- Tom Holvoet
- Principal Investigator Email
- tom.holvoet@vitaz.be
- Contact Person Name
- Tom Holvoet
- Contact Person Email
- tom.holvoet@vitaz.be
- Site Name
- Imelda
- Department Name
- Gastroenterology
- Principal Investigator Name
- Lieven Pouillon
- Principal Investigator Email
- lieven.pouillon@imelda.be
- Contact Person Name
- Lieven Pouillon
- Contact Person Email
- lieven.pouillon@imelda.be
Hungary
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 563
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Semmelweis University
- Department Name
- 2nd Dept. of Internal Medicine
- Principal Investigator Name
- Zsolt Tulassay
- Principal Investigator Email
- tulassay.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Tulassay
- Contact Person Email
- tulassay.zsolt@med.semmelweis-univ.hu
- Site Name
- Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
- Principal Investigator Name
- G. Kiss Gyula
- Principal Investigator Email
- gkissgyula@gmail.com
- Contact Person Name
- G. Kiss Gyula
- Contact Person Email
- gkissgyula@gmail.com
- Site Name
- Semmelweis University (Koranyi Sandor Utca)
- Department Name
- Internal Medicine and Oncology Clinic
- Principal Investigator Name
- Ákos Iliás
- Principal Investigator Email
- driliasakos@gmail.com
- Contact Person Name
- Ákos Iliás
- Contact Person Email
- driliasakos@gmail.com
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Marta Varga
- Principal Investigator Email
- drvargamarta@gmail.com
- Contact Person Name
- Marta Varga
- Contact Person Email
- drvargamarta@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 501
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- PreventaMed s.r.o.
- Principal Investigator Name
- Jiří Pumprla
- Principal Investigator Email
- research@vilazdravi.cz
- Contact Person Name
- Jiří Pumprla
- Contact Person Email
- research@vilazdravi.cz
- Site Name
- Nemocnice Slany
- Department Name
- Interní klinika
- Principal Investigator Name
- Martin Peterka
- Principal Investigator Email
- peterka.studie@seznam.cz
- Contact Person Name
- Martin Peterka
- Contact Person Email
- peterka.studie@seznam.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 476
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Nuestra Senora De Candelaria
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Milagros Vela
- Principal Investigator Email
- milvelillas@yahoo.es
- Contact Person Name
- Milagros Vela
- Contact Person Email
- milvelillas@yahoo.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Servicio de Gastroenterologia
- Principal Investigator Name
- Federico Arguelles-Arias
- Principal Investigator Email
- farguelles@telefonica.net
- Contact Person Name
- Federico Arguelles-Arias
- Contact Person Email
- farguelles@telefonica.net
- Site Name
- Hospital Universitario Juan Ramon Jimenez
- Department Name
- Servicio de Digestivo
- Principal Investigator Name
- Ana Bejarano Garcia
- Principal Investigator Email
- ana.bejarano.garcia.sspa@juntadeandalucia.es
- Contact Person Name
- Ana Bejarano Garcia
- Contact Person Email
- ana.bejarano.garcia.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Cabuenes
- Department Name
- Unidad de Enfermedad Inflamatoria Intestinal
- Principal Investigator Name
- Pilar Varela Trastoy
- Principal Investigator Email
- trastoy@hotmail.com
- Contact Person Name
- Pilar Varela Trastoy
- Contact Person Email
- trastoy@hotmail.com
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- Servicio de Digestivo
- Principal Investigator Name
- Ana Isabel Echarri Piudo
- Principal Investigator Email
- ana.echarri.piudo@sergas.es
- Contact Person Name
- Ana Isabel Echarri Piudo
- Contact Person Email
- ana.echarri.piudo@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Gastroenterologia
- Principal Investigator Name
- Maria Isabel Iborra Colomino
- Principal Investigator Email
- marisaiborra@hotmail.com
- Contact Person Name
- Maria Isabel Iborra Colomino
- Contact Person Email
- marisaiborra@hotmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 673
- Number Of Sites
- 21
- Number Of Participants
- 81
Sites
- Site Name
- Bodyclinic Sp. z o.o. sp.k.
- Principal Investigator Name
- Piotr Gietka
- Principal Investigator Email
- piotrgietka@gmail.com
- Contact Person Name
- Piotr Gietka
- Contact Person Email
- piotrgietka@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
- Medical Network Sp. z o.o.
- Principal Investigator Name
- Jarosław Kierkuś
- Principal Investigator Email
- j.kierkus@wip.waw.pl
- Contact Person Name
- Jarosław Kierkuś
- Contact Person Email
- j.kierkus@wip.waw.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Principal Investigator Name
- Rafał Filip
- Principal Investigator Email
- r.s.filip@wp.pl
- Contact Person Name
- Rafał Filip
- Contact Person Email
- r.s.filip@wp.pl
- Site 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
- Futuremeds Sp. z o.o.
- Principal Investigator Name
- Szymon Wieczorek
- Principal Investigator Email
- szymon.wieczorek@futuremeds.com
- Contact Person Name
- Szymon Wieczorek
- Contact Person Email
- szymon.wieczorek@futuremeds.com
- Site Name
- Rivermed Sp. z o.o.
- Principal Investigator Name
- Łukasz Hordecki
- Principal Investigator Email
- l.hordecki@rivermed.pl
- Contact Person Name
- Łukasz Hordecki
- Contact Person Email
- l.hordecki@rivermed.pl
- Site Name
- Gyncentrum Sp. z o.o.
- Principal Investigator Name
- Marek Olakowski
- Principal Investigator Email
- m.olakowski@holsaclinical.com
- Contact Person Name
- Marek Olakowski
- Contact Person Email
- m.olakowski@holsaclinical.com
- Site Name
- Sonomed Sp. z o.o.
- Principal Investigator Name
- Anna Wiechowska Kozłowska
- Principal Investigator Email
- annamwk@wp.pl
- Contact Person Name
- Anna Wiechowska Kozłowska
- Contact Person Email
- annamwk@wp.pl
- Site Name
- Futuremeds Sp. z o.o. (Kraków)
- Department Name
- FutureMeds Kraków
- Principal Investigator Name
- Piotr Rozpondek
- Principal Investigator Email
- piotr.rozpondek@futuremeds.com
- Contact Person Name
- Piotr Rozpondek
- Contact Person Email
- piotr.rozpondek@futuremeds.com
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Radosław Kempiński
- Principal Investigator Email
- radoslaw.kempinski@cmoporow.com
- Contact Person Name
- Radosław Kempiński
- Contact Person Email
- radoslaw.kempinski@cmoporow.com
- Site Name
- Vivamed Sp. z o.o.
- Principal Investigator Name
- Robert Petryka
- Principal Investigator Email
- robert@petrykamed.com
- Contact Person Name
- Robert Petryka
- Contact Person Email
- robert@petrykamed.com
- Site Name
- Centrum Innowacyjnych Terapii Sp. z o.o.
- Principal Investigator Name
- Witold Kucharski
- Principal Investigator Email
- witold.kucharski@citrials.pl
- Contact Person Name
- Witold Kucharski
- Contact Person Email
- witold.kucharski@citrials.pl
- Site Name
- Medrise Sp. z o.o.
- Principal Investigator Name
- Wit Danilkiewicz
- Principal Investigator Email
- wit.danilkiewicz@medrise.pl
- Contact Person Name
- Wit Danilkiewicz
- Contact Person Email
- wit.danilkiewicz@medrise.pl
- Site Name
- Manermed Sp. z o.o.
- Department Name
- Centrum Medyczne Medis
- Principal Investigator Name
- Maria Kłopocka
- Principal Investigator Email
- mariaklopocka@cm-medis.pl
- Contact Person Name
- Maria Kłopocka
- Contact Person Email
- mariaklopocka@cm-medis.pl
- Site Name
- EMC Instytut Medyczny S.A. (Wrocław)
- Department Name
- Penta Hospitals Przychodnie, Wrocław Wejherowska
- 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
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- gawdis@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- gawdis@twojaprzychodnia.com
- Site Name
- Care Access Polska Sp. z o.o.
- Principal Investigator Name
- Łukasz Jałocha
- Principal Investigator Email
- s.borek@careaccess.com
- Contact Person Name
- Łukasz Jałocha
- Contact Person Email
- s.borek@careaccess.com
- Site Name
- Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
- Principal Investigator Name
- Krystyna Stec-Michalska
- Principal Investigator Email
- stemii@wp.pl
- Contact Person Name
- Krystyna Stec-Michalska
- Contact Person Email
- stemii@wp.pl
- Site Name
- EMC Instytut Medyczny S.A. (Poznan)
- Principal Investigator Name
- Piotr Szabłowski
- Principal Investigator Email
- szapi@mp.pl
- Contact Person Name
- Piotr Szabłowski
- Contact Person Email
- szapi@mp.pl
- Site Name
- Endoskopia Sp. z o.o.
- Principal Investigator Name
- Dariusz Kleczkowski
- Principal Investigator Email
- szach999@wp.pl
- Contact Person Name
- Dariusz Kleczkowski
- Contact Person Email
- szach999@wp.pl
France
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 670
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de Gastro-Entérologie
- Principal Investigator Name
- Arnaud Bourreille
- Principal Investigator Email
- arnaud.bourreille@chu-nantes.fr
- Contact Person Name
- Arnaud Bourreille
- Contact Person Email
- arnaud.bourreille@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Gastro-Entérologie
- 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
- 16-05-2024
- Latest Decision Or Authorization Date
- 14-05-2026
- Processing Time Days
- 728
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Gastroenterology and Gastrointestinal Endoscopy Unit
- Principal Investigator Name
- Silvio Danese
- Principal Investigator Email
- danese.silvio@hsr.it
- Contact Person Name
- Silvio Danese
- Contact Person Email
- danese.silvio@hsr.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- U.O. 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
Germany
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 684
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Stefan Schreiber
- Principal Investigator Email
- stefan.schreiber@uksh.de
- Contact Person Name
- Stefan Schreiber
- Contact Person Email
- stefan.schreiber@uksh.de
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development L.P.
- Responsibilities
- CRO
Third parties
- {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"Subject devices/ site tablets","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Endoscopy imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"Blinded enrollment/randomization","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Arensia Exploratory Medicine S.R.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"Contract negotiation with PI; Feasibility","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- GS-1427 25 mg tablets
- Active Substance
- GS-1427
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 25 mg
- Dose Levels
- 25 mg
- Maximum Dose
- 25 mg (maxDailyDoseAmount)
- Dose Escalation Increase
- 25 mg; 75 mg; 100 mg
- Investigational Product Name
- GS-1427 75 mg tablets
- Active Substance
- GS-1427
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 75 mg
- Dose Levels
- 75 mg
- Maximum Dose
- 75 mg (maxDailyDoseAmount)
- Dose Escalation Increase
- 25 mg; 75 mg; 100 mg
- Investigational Product Name
- GS-1427 100 mg tablets
- Active Substance
- GS-1427
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Maximum Dose
- 100 mg (maxDailyDoseAmount)
- Dose Escalation Increase
- 25 mg; 75 mg; 100 mg
- Investigational Product Name
- PTM 25 mg Tablets (placebo)
- Modality
- Other
- Dose Levels
- 25 mg (placebo match)
- Investigational Product Name
- PTM 75 mg Tablets (placebo)
- Modality
- Other
- Dose Levels
- 75 mg (placebo match)
- Investigational Product Name
- PTM 100 mg Tablets (placebo)
- Modality
- Other
- Dose Levels
- 100 mg (placebo match)
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