Clinical trial • Phase II • Gastroenterology

AZD7798 for Crohn's disease

Phase II trial of AZD7798 for Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
29-10-2024

Trial design

Randomised, open-label, azd7798 placebo (azd7798 placebo, placebo comparator, route: sc); active comparator is azd7798 (subcutaneous). dose and schedule not specified in the public record.-controlled Phase II trial in Italy, Poland, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
AZD7798 Placebo (AZD7798 Placebo, placebo comparator, route: SC); active comparator is AZD7798 (subcutaneous). Dose and schedule not specified in the public record.
Target Sample Size
116
Trial Duration For Participant
252

Eligibility

Recruits 116 Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be capable of giving signed informed consent ("Capable of giving signed informed consent"). The study enrols adults only (minimum age 18), so no assent/parental consent procedures for minors are specified..

Pregnancy Exclusion
Reproduction: (a) Pregnant and breastfeeding patients, or those planning to breastfeed during the study (b) FOCBP, unless they agree to complete abstinence or to use a highly effective contraceptive method AND barrier method from enrolment until 18 weeks following last drug administration. FONCBP may be included
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be capable of giving signed informed consent ("Capable of giving signed informed consent"). The study enrols adults only (minimum age 18), so no assent/parental consent procedures for minors are specified.

Inclusion criteria

  • {"criterion_text":"- 18 to 80 years of age inclusive, at the time of signing the ICF."}
  • {"criterion_text":"- Diagnosis of Crohn’s disease established with verifiable clinical, AND at least one of imaging, endoscopic, and/or histopathologic evidence."}
  • {"criterion_text":"- Capable of giving signed informed consent"}
  • {"criterion_text":"- A history of at least one of (a) Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy OR (b) Corticosteroid dependency."}
  • {"criterion_text":"- Moderate to severe active Crohn’s disease as determined by: (a) CDAI score of 220-450 during screening OR CDAI score of 200-450 during screening for ileal/ileocecal disease AND (b) Active intestinal mucosal inflammation, as demonstrated on centrally-read video-recorded ileocolonoscopy performed during the screening period with the following findings: (I) SES-CD ≥ 6 OR (II) SES-CD ≥ 4 for ileal/ileocecal disease."}
  • {"criterion_text":"- Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation."}

Exclusion criteria

  • {"criterion_text":"- Evidence, or clinical suspicion, of other forms of IBD (ulcerative colitis, indeterminate colitis) or concomitant additional active gastrointestinal luminal inflammatory diseases including, but not limited to, infectious colitis, ischaemic colitis, radiation colitis, microscopic colitis, and uncontrolled coeliac disease."}
  • {"criterion_text":"- Any of the following treatments within the specified time period prior to screening endoscopy visit: (a) An anti-TNF biologic within 8 weeks prior to screening endoscopy visit, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable (b) Any biologic targeting immune response (including vedolizumab and ustekinumab) other than an anti-TNF within 12 weeks prior to screening endoscopy visit unless validated therapeutic drug monitoring is performed, and drug concentrations are undetectable. (c) Other advanced small molecule treatments for Crohn’s disease (including JAK inhibitors or S1P modulators) within 4 weeks prior to screening endoscopy visit (d) Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit (e) Treatment with apheresis within 4 weeks prior to screening endoscopy visit (f) Administration of any live vaccine within 4 weeks prior to screening endoscopy visit, or planned administration of any such vaccine over the course of the study (g) Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit (h) Lymphocyte-depleting treatment, within 12 months prior to screening endoscopy visit (i) Any previous exposure to AZD7798."}
  • {"criterion_text":"- Any changes in dosing of the following medications prior to screening endoscopy visit as outlined: (a) 5-aminosalicylates within 2 weeks (b) Oral corticosteroids within 2 weeks or stable doses of steroids exceeding the following dose equivalents: (i) Systemic steroids > 20 mg/day prednisolone equivalent (see Appendix N) (ii) Locally targeted steroids exceeding maximum budesonide dose equivalent (9 mg/day]) (c) Immunomodulators (thiopurines or methotrexate) within 4 weeks (d) Antibiotic therapy for the treatment of Crohn’s disease, eg, ciprofloxacin or metronidazole within 2 weeks (e) Probiotics within 2 weeks."}
  • {"criterion_text":"- Known or suspected history of chronic use of nonsteroidal anti-inflammatory drugs (defined as at least 3 times per week for more than 3 months; not applicable to daily aspirin use up to 325 mg per day)."}
  • {"criterion_text":"- Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit. Topical antimicrobials or antimicrobials for the treatment of uncomplicated urinary tract infection may be allowed at the Medical Monitor’s discretion."}
  • {"criterion_text":"- Evidence of chronic HBV or HCV infection defined as: (a) HBV: HBsAg positive or HBcAb positive (b) HCV: Positive result for HCV IgM Ab is exclusionary. Positive result for HCV IgG is acceptable only if RNA is undetectable, and at least 12 weeks post-antiviral treatment of HCV if treated."}
  • {"criterion_text":"- History of TB (active or latent), unless an appropriate course of treatment has been completed."}
  • {"criterion_text":"- Positive diagnostic TB test at screening suggestive of current TB infection."}
  • {"criterion_text":"- History of serious opportunistic infection within 12 months prior to screening endoscopy visit"}
  • {"criterion_text":"- CMV colitis within previous 12 months prior to screening endoscopy visit."}
  • {"criterion_text":"- Positive C. difficile toxin stool test at screening."}
  • {"criterion_text":"- Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon."}
  • {"criterion_text":"- Symptomatic herpes zoster infection within 3 months prior to screening endoscopy visit."}
  • {"criterion_text":"- Any identified immunodeficiency, congenital and/or acquired aetiologies, including, but not limited to: (a) HIV infection (patients with positive results of HIV testing by the central laboratory will be excluded) (b) Splenectomy (c) Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant (d) Primary immune deficiency diseases, excluding selective IgA deficiency."}
  • {"criterion_text":"- Abnormal laboratory results at screening: (a) Haemoglobin < 8 g/dL (b) Neutrophil count < 1,500/μL (or < 1.5 × 109/L); a re-test is allowed during screening in cases of mild leukopenia clinically suspected to be transient (c) Lymphocytes < 500/μL (or < 0.5 × 109/L) (d) Liver tests: AST/ALT/ALP > 2 × ULN; or TBL ≥ 1.5 × ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) (e) eGFR according to CKD-EPI formula < 30 mL/min (f) Any other abnormal laboratory results at screening, which, in the opinion of the Investigator, will prevent the patient from completing the study or will interfere with the interpretation of the study results."}
  • {"criterion_text":"- Reproduction: (a) Pregnant and breastfeeding patients, or those planning to breastfeed during the study (b) FOCBP, unless they agree to complete abstinence or to use a highly effective contraceptive method AND barrier method from enrolment until 18 weeks following last drug administration. FONCBP may be included"}
  • {"criterion_text":"- Prolonged QTcF interval (QTc > 450 ms, or QTc > 480 ms, for patients with bundle branch block) or congenital long-QT syndrome or family history of long-QT syndrome or sudden cardiac death in age < 40 years. In case of a borderline result or concern for artifact, triplicate ECGs should be collected within a 10-minute period, and the averaged value calculated for decision making."}
  • {"criterion_text":"- Clinically significant cardiovascular conditions including: (a) Acute coronary syndrome (acute myocardial infarction, unstable angina), coronary intervention with percutaneous coronary intervention/coronary artery bypass surgery, stroke, transient ischaemic attack within 6 months prior to screening endoscopy visit (b) Decompensated heart failure requiring hospitalisation, or Class III/IV heart failure, within 6 months prior to screening endoscopy visit (c) Untreated second degree, Mobitz II or third degree atrioventricular-block, significant sinus node dysfunction/pause or therapy requiring tachyarrhythmia. Patients with atrial fibrillation/flutter and optimally controlled ventricular rate (resting rate < 100 bpm) may be eligible as judged by the Investigator (d) Hypertrophic cardiomyopathy or clinically significant valvular heart disease which, in the opinion of the Investigator, will prevent the patient from completing the study or will interfere with the interpretation of the study results."}
  • {"criterion_text":"- Current malignancy or history of malignancy, except for: (a) Basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to screening endoscopy visit. (b) Other non-gastrointestinal malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to screening endoscopy visit."}
  • {"criterion_text":"- Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease including large duct primary sclerosing cholangitis, renal disease, gastrointestinal disease, or other major disease other than active Crohn’s disease."}
  • {"criterion_text":"- Current enrolment in another interventional study or treatment with any investigational drug within 4 months (or 5 half-lives, whichever is longer) prior to screening endoscopy visit."}
  • {"criterion_text":"- Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the Investigator they would interfere with the ability of a patient to complete the study."}
  • {"criterion_text":"- Any complications of Crohn’s disease where surgery is anticipated or planned prior to end of study treatment."}
  • {"criterion_text":"- Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities."}
  • {"criterion_text":"- Evidence of extensive prior gastrointestinal surgical interventions, including: (a) > 2 small bowel resection surgeries (b) Extensive colonic resection: hemicolectomy, subtotal or total colectomy (c) Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to screening. Patients with a current stoma are excluded irrespective of the time from surgery (d) Short bowel syndrome."}
  • {"criterion_text":"- Within 3 months prior to screening endoscopy visit: (a) History of toxic megacolon (b) Diagnosis of peritonitis or need for treatment of peritonitis (c) Bowel perforation or evidence of obstruction."}
  • {"criterion_text":"- Undrained cutaneous and perianal or perirectal abscesses and fistula, and all intrabdominal abscesses."}
  • {"criterion_text":"- Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study."}
  • {"criterion_text":"- Evidence of an increased risk of colorectal cancer, including: (a) Adenomatous colonic polyps that have not been removed (b) Colonic mucosal dysplasia (c) Family history of early onset colorectal cancer, established diagnosis of HNPCC, pancolitis for > 8 years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if clinically appropriate per Investigator)."}
  • {"criterion_text":"- Symptomatic oral Crohn’s disease within one year is excluded with the exception of aphthous ulcers not requiring oral specialist intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- CDAI remission (CDAI score < 150)","definition_or_measurement_approach":"CDAI score < 150"}

Secondary endpoints

  • {"endpoint_text":"- Endoscopic response (> 50% decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score). Participants who meet definition of endoscopic remission will be considered to also have met endoscopic response.","definition_or_measurement_approach":"> 50% decrease from baseline in SES-CD total score; participants meeting endoscopic remission definition are also considered to have met endoscopic response."}
  • {"endpoint_text":"- Endoscopic remission *SES-CD total score ≤ 2 OR *SES-CD total score ≤ 4 (≤ 2 with ileal/ileocecal disease) and at least 2-point decrease from baseline with no individual subscore > 1","definition_or_measurement_approach":"SES-CD total score ≤ 2 OR SES-CD total score ≤ 4 (≤2 with ileal/ileocecal disease) and at least 2-point decrease from baseline with no individual subscore > 1."}
  • {"endpoint_text":"- Endoscopic score change from baseline","definition_or_measurement_approach":"Change in SES-CD total score from baseline."}
  • {"endpoint_text":"- CDAI response (≥ 100 points decrease from the baseline CDAI or CDAI score < 150 points)","definition_or_measurement_approach":"≥100-point decrease from baseline CDAI or CDAI < 150."}
  • {"endpoint_text":"- CDAI score change from baseline","definition_or_measurement_approach":"Change in CDAI score from baseline."}
  • {"endpoint_text":"- Symptomatic remission (average daily stool frequency ≤ 2.8 AND average daily abdominal pain ≤ 1, and neither worse than baseline)","definition_or_measurement_approach":"Average daily stool frequency ≤ 2.8 AND average daily abdominal pain ≤ 1, neither worse than baseline."}
  • {"endpoint_text":"- Serum AZD7798 concentration and incidence and titre of anti-drug antibody (ADA) response","definition_or_measurement_approach":"Measurement of serum AZD7798 concentration (PK) and incidence/titre of anti-drug antibodies (immunogenicity assays)."}

Recruitment

Planned Sample Size
116
Recruitment Window Months
35
Consent Approach
Signed informed consent required from each participant; participants must be capable of giving signed informed consent. Informed consent forms and subject information sheets are provided (multiple language versions are included in the submission documents). No assent procedures for minors are specified because minimum age is 18.

Geography

Total Number Of Sites
69
Total Number Of Participants
77

Italy

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
284
Number Of Sites
6
Number Of Participants
4

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
UOC Gastroenterology Endoscopi Digestive
Contact Person Name
Giovanni Maconi
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Gastroenterology
Contact Person Name
Francesca Rogai
Contact Person Email
frogai@hotmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
IBD Unit - Department of Gastroenterology
Contact Person Name
Rocco Cosintino
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Gastrointestinal Endoscopic unit
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Gastroenterology Unit
Contact Person Name
Michele Cicala
Contact Person Email
m.cicala@policlinicocampus.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department of Medical and Surgical Sciences - UOC CEMAD
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it

Poland

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
280
Number Of Sites
15
Number Of Participants
20

Sites

Site Name
Melita Medical Sp. z o.o.
Department Name
Centrum Medyczne Melita Medical
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Centrum Medyczne Lukamed Joanna Luka
Department Name
Centrum Medyczne Lukamed Joanna Łuka
Contact Person Name
Piotr Drobinski
Contact Person Email
piotrdrobinski@lukamed.com
Site Name
Vivamed Sp z o.o.
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com
Site Name
Manermed Sp. z o.o.
Department Name
Centrum Medyczne Medis
Contact Person Name
Maria Klopocka
Contact Person Email
mariaklopocka@wp.pl
Site Name
Planetmed Sp. z o.o.
Department Name
Planetmed Gastroenterologia
Contact Person Name
Barbara Wozniak-Stolarska
Contact Person Email
basiastolarska@interia.pl
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia PCM
Contact Person Name
Ewa Furmanowska-Ladorska
Site Name
Medrise Sp. z o.o.
Department Name
Medrise sp. z o.o.
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wit.danilkiewicz@medrise.pl
Site Name
Vistamed & Vertigo Sp. z o.o.
Contact Person Name
Bernadeta Frysna
Contact Person Email
b.frysna@vistamed.pl
Site Name
Promed P.Lach R.Glowacki Sp. j.
Department Name
Centrum Medyczne Promed
Contact Person Name
Danuta Owczarek
Contact Person Email
dowczarek@cmpromed.pl
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Department Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Beata Klincewicz
Contact Person Email
beata.klincewicz@cr-center.pl
Site Name
Eb Group Sp. z o.o.
Department Name
Centrum Zdrowia MDM
Contact Person Name
Marek Woynarowski
Contact Person Email
marek.woynarowski@czmdm.pl
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
Centrum Medyczne Plejady
Contact Person Name
Monika Augustyn
Contact Person Email
amonika@interia.pl
Site Name
Endoskopia Sp. z o.o.
Department Name
Endoskopia
Contact Person Name
Marek Horynski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Solumed Sp. z o.o. sp.k.
Department Name
Solumed Centrum Medyczne
Contact Person Name
Magdalena Andrzejewska

Germany

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
261
Number Of Sites
8
Number Of Participants
5

Sites

Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Gastroenterology
Contact Person Name
Daniel Baumgart
Contact Person Email
Daniel.baumgart@uni-potsdam.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Internal Medicine I
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Gastroenterology
Contact Person Name
Andreas Stallmach
Site Name
Krankenhaus Waldfriede e.V.
Department Name
Innere Medizin
Contact Person Name
Carsten Büning
Contact Person Email
c.buening@waldfriede.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Medizinische Klinik
Contact Person Name
Irina Blumenstein
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
Gastroenterology
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Clinic for Internal Medicine
Contact Person Name
Stefan Schreiber
Contact Person Email
stefan.schreibe@uksh.de
Site Name
Universitaetsklinikum Ulm AöR (duplicate contact listed)
Department Name
Internal Medicine I
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de

Romania

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
301
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Elias University Emergency Hospital
Department Name
Gastroenterology, hepatology and digestive endoscopy
Contact Person Name
Adrian Saftoiu
Site Name
Gastro Med S.R.L.
Department Name
Internal Medicine
Contact Person Name
Andrada Seicean
Contact Person Email
andradaseicean@gmail.com
Site Name
Memorial Healthcare International S.R.L.
Department Name
Gastroenterology
Contact Person Name
Ion-Eugeniu Craciun
Contact Person Email
eugencraciun@yahoo.com
Site Name
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Department Name
Gastroenterology
Contact Person Name
Adrian Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Contact Person Name
Bogdan Mateescu
Contact Person Email
gastrostudii@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
274
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Department of Internal Medicine-Gastroenterology
Contact Person Name
Markus Peck-Radosavljevic
Contact Person Email
markus@peck.at
Site Name
Medical University Of Vienna
Department Name
Devision of Gastroenterology and Hepatology
Contact Person Name
Walter Reinisch

Croatia

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
286
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Clinical Hospital Dubrava
Department Name
Gastroenterology and Hepatology
Contact Person Name
Zeljko Cabrijan
Contact Person Email
zcabrijan@gmail.com
Site Name
Poliklinika Borzan d.o.o.
Department Name
Gastroenterology
Contact Person Name
Vladimir Borzan
Contact Person Email
info@poliklinika-borzan.hr
Site Name
KBC Zagreb
Department Name
Gastroenterology
Contact Person Name
Zeljko Krznaric
Contact Person Email
kbc-zagreb@kbc-zagreb.hr

Spain

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
326
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Gastroenterology
Contact Person Name
Ana Gutierrez Casbas
Contact Person Email
Anitaguti2002@gmail.com
Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Servicio de Aparato Digestivo
Contact Person Name
Miquel Sans Cuffi
Contact Person Email
miguel.sans@quironsalud.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Gastroenterology
Contact Person Name
Daniel Ceballos Santos
Contact Person Email
Dcebsan@gobiernodecanarias.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology
Contact Person Name
Eduardo Leo Carnerero
Contact Person Email
eduardoleo70@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Digestivo
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
martinarranz.lapaz@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
341
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Clinexpert Gyoengyoes Kft.
Contact Person Name
Gyula Horvát
Contact Person Email
horvatgyula@gmail.com
Site Name
Semmelweis University
Department Name
Surgical, Transplant and Gastroenterology Clinic
Contact Person Name
Pál Miheller
Contact Person Email
pmiheller@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
4. Internal medicine-Gastroenterology
Contact Person Name
Márta Varga
Contact Person Email
drvargamarta@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
308
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Stomach, intestinal and liver diseases
Contact Person Name
Jeroen Geldof
Contact Person Email
jeroen.geldof@uzgent.be
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Gastroenterology
Contact Person Name
Veerle Mattens
Contact Person Email
veerle.mattens@olvz-aalst.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Gastroenterology, hepatology, onco. digestive service
Contact Person Name
Catherine Reenaers
Contact Person Email
catherine.reenaers@chuliege.be
Site Name
Katholieke Universiteit te Leuven
Department Name
Gastroenterology and Hepatology
Contact Person Name
Bram Verstockt
Contact Person Email
bram.verstockt@uzleuven.be

Netherlands

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
281
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
Stichting Radboud Universitair Medisch Centrum Radboud University Medical Center Radboudumc
Department Name
Gastroenterology
Contact Person Name
Marjolijn Duijvestein
Site Name
Amsterdam UMC Academisch Medisch Centrum
Department Name
Gastroenterology
Contact Person Name
Geert D'Haens
Contact Person Email
g.dhaens@amsterdamumc.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Gastroenterology and Hepatology
Contact Person Name
Maurice Lutgens
Contact Person Email
m.lutgens@etz.nl

Sweden

Earliest CTIS Part Ii Submission Date
05-09-2024
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
281
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Oestergoetland
Department Name
Magtarmmedicinska kliniken
Contact Person Name
Henrik Hjortswang
Site Name
Ersta Sjukhus-Ersta Hospital
Department Name
Gastroenheten, Medicinkliniken
Contact Person Name
Ann-Sofie Backman

France

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
412
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hepato-gastro-enterology A
Contact Person Name
Romain Altwegg
Contact Person Email
r-altwegg@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’Hépato-Gastroentérologie
Contact Person Name
Mathurin Fumery
Contact Person Email
fumery.mathurin@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Digestive tract diseases department
Contact Person Name
Maria Nachury
Contact Person Email
maria.nachury@chu-lille.fr
Site Name
Hospices Civils De Lyon
Department Name
Gastroenterology
Contact Person Name
Gilles Boschetti
Contact Person Email
Gilles.boschetti@chu-lyon.fr
Site Name
CHRU De Nancy
Department Name
Gastroenterology- clinical Investigation Unit
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr

Slovakia

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
514
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Fakultna Nemocnica Trnava
Department Name
Gastroenterology department
Contact Person Name
Rastislav Husťak
Contact Person Email
rastislav.hustak@fntt.sk
Site Name
Gastro I. s.r.o.
Department Name
Outpatient care for Gastroenterology
Contact Person Name
Bohuš Bunganič
Contact Person Email
gastrobunganic@gmail.com
Site Name
KM Management spol. s r.o.
Department Name
Ambulance of Gastroenterology
Contact Person Name
Miloš Greguš
Contact Person Email
ghugregus@gmail.com
Site Name
Endomed s.r.o.
Department Name
Outpatient care for Gastroenterology
Contact Person Name
Miroslav Fedurco
Contact Person Email
endomed@endomed.sk

Bulgaria

Earliest CTIS Part Ii Submission Date
04-09-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
527
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Clinic of Gastroenterology
Contact Person Name
Desislav Stanchev
Contact Person Email
dessislavs.gmail@abbvie.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Internal Department
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmediaplus.com
Site Name
Acibadem City Clinic University Hospital EOOD
Department Name
Clinic of Gastroenterology
Contact Person Name
Asen Petrov
Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
Gastroenterology
Contact Person Name
Plamen Penchev
Contact Person Email
Penchev.dr@gmail.com

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD7798
Active Substance
AZD7798
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Investigational Product Name
AZD7798 Placebo
Modality
Other

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