Clinical trial • Phase II • Gastroenterology

METHYL (E,6S)-7-[[1-[2-(2-ETHYLBUTYLAMINO)-2-OXOETHYL]-2-OXOPYRIDIN-3-YL]AMINO]-6-[(3-METHYLIMIDAZOLE-4-CARBONYL)AMINO]-7-OXOHEPT-2-ENOATE for Celiac disease

Phase II trial of METHYL (E,6S)-7-[[1-[2-(2-ETHYLBUTYLAMINO)-2-OXOETHYL]-2-OXOPYRIDIN-3-YL]AMINO]-6-[(3-METHYLIMIDAZOLE-4-CARBONYL)AMINO]-7-OXOHEPT-2-ENOA…

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Celiac disease
Trial Stage
Phase II
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
11-12-2023
First CTIS Authorization Date
16-04-2024

Trial design

Randomised, placebo matching with zed1227 capsules of dr. falk pharma gmbh (oral placebo matched to zed1227 capsules).-controlled Phase II trial in Spain, Austria, Norway and others.

Randomised
Yes
Comparator
Placebo matching with ZED1227 capsules of Dr. Falk Pharma GmbH (oral placebo matched to ZED1227 capsules).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
253
Trial Duration For Participant
105

Eligibility

Recruits 253 Vulnerable population selected. Participants must provide "Signed informed consent". All participants are adults (18–80 years), so no child assent is required. Institutionalised subjects because of legal or regulatory order are explicitly excluded. Subject information and informed consent forms (L1_SIS and ICF) are provided and country/language-specific ICFs are available..

Pregnancy Exclusion
Existing or intended pregnancy or breast-feeding
Vulnerable Population
Vulnerable population selected. Participants must provide "Signed informed consent". All participants are adults (18–80 years), so no child assent is required. Institutionalised subjects because of legal or regulatory order are explicitly excluded. Subject information and informed consent forms (L1_SIS and ICF) are provided and country/language-specific ICFs are available.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Willingness to follow her/his usual dietary patterns, including eating at restaurants and others’ homes during the trial\n- Willingness to maintain current GFD throughout participation in the trial\n- Negative pregnancy test in female subjects under 60 years of age at Screening Visit and Baseline Visit B\n- Women of child-bearing potential should use a highly effective method of birth control which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptive pills, combined contraceptive patches and vaginal rings, copper containing intrauterine devices, sexual abstinence or vasectomised partner (see Table 11 for further information on acceptable and unacceptable birth control methods). The investigator is responsible for determining whether the subject has adequate birth control for trial participants\n- Men or women between 18 and 80 years of age, inclusively\n- Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation TG2-IgA > 10 x upper limit of normal (ULN) at diagnosis at least 12 months prior to V0\n- Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0\n- Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease\n- At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating, or nausea) during the last 4 weeks prior to Baseline Visit A and last 3 weeks prior to Baseline Visit B as a GI total mean symptom score (measured using CDSD) for the worst 25% of the days of ≥ 2 on a 5-point scale. The interval between Screening Visit and Baseline Visit A must be at least 28 days. If the interval is less than 28 days, this inclusion criterion is not met,\n- Biopsy showing VH:CrD ratio of ≤ 2.5 from distal duodenum biopsies in Trial Period A\n- Negative diagnosis of Helicobacter pylori infection and no history of eradication within the last two months before biopsy sampling in Trial Period A\n- BMI between 17.0 and 35 kg/m², inclusively"}

Exclusion criteria

  • {"criterion_text":"- Presence of hypo- or hyperthyroidism. A patient with a thyroid stimulating hormone (TSH) level up to 25% higher than ULN or up to 25% lower than the lower limit of normal (LLN) but with normal free triiodothyronine (FT3) and free thyroxine (FT4) levels can be included in the trial. In addition, a patient with a well-controlled thyroid disorder during the previous 3 months can be included\n- Food allergies to nongluten ingredients (tapioca syrup, oats, almonds, rice crisp, chocolate, almond butter, cocoa butter, oat flour, glycerine, sunflower lecithin, salt, and natural flavours) of the SIGE bar or significant symptoms upon ingestion of the gluten-free SIGE bar\n- Known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten\n- Patients diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3/CD8 immunohistochemistry) and if they do not present with very severe symptoms and/or parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine\n- If more than 10% of planned enrolled subjects report a greater than 1 point improvement in PGI-S during Trial Period A, further subjects with > 1 point improvement in PGI-S will be excluded\n- Known intolerance/hypersensitivity/resistance to the investigational medicinal product (IMP) and excipients or drugs of similar chemical structure or pharmacological profile\n- Doubt about the subject’s cooperation, e.g., because of addiction to alcohol or drugs\n- Existing or intended pregnancy or breast-feeding\n- Close affiliation with the investigator (e.g., a close relative) or persons working at the study sites (if financially dependent on the investigator) or subject who is an employee of the Sponsor’s company\n- Subjects who are institutionalised because of legal or regulatory order\n- Participation in another clinical trial of a therapeutic and having received IMP within the last 30 days prior to V0 or within 5 half-lives of IMP (whichever is longer), or participation in another clinical trial related to celiac disease within 12 months prior to screening, or simultaneous participation in another clinical intervention trial, or previous participation in this trial and having received IMP.\n- Abnormal hepatic function (alkaline aminotransferase [ALT] or alkaline phosphatase [ALP] > 2.5 x ULN), liver cirrhosis, or portal hypertension\n- Continuous intake of systemic (oral or intravenous) corticosteroids or immunomodulators (e.g., glucocorticoids, cyclosporine, methotrexate, anti-TNF- therapy, anti-integrin therapy, Janus kinase inhibitors), high dose inhaled corticosteroids (> 1000 µg/d of beclomethasone dipropionate or equivalent) during the past 3 months before V0\n- Continuous intake of drugs with suspicion of impact on villous atrophy, such as •\tproton-pump inhibitors (PPIs; permitted at a regular dose equivalent to 20-40 mg/day pantoprazol, esomeprazole or equivalent), •\tselective serotonin reuptake inhibitors (SSRIs; low to medium dose [10-150 mg Fluvoxamine or equivalent dose of other SSRIs] permitted in case of long-term therapy [at least for 6 months]), •\tlosartan (angiotensin II receptor blockers equivalent to 50 mg losartan permitted except for olmesartan forbidden at any dose) and •\tmycophenolate1,2 (forbidden at any dose) during the past 2 months before biopsy sampling in Trial Period A; •\tnon-steroidal anti-inflammatory drugs (NSAIDs; maximal daily dose permitted 900 mg for ibuprofen, 500 mg for naproxen and 75 mg for diclofenac, except for one week before biopsy) and •\tacetylsalicylic acid (max daily dose permitted 100 mg) during the past 4 weeks before biopsy sampling at Baseline Visit A\n- Alcohol use > 12 g/d for women, > 24 g/d for men within the past 12 months before screening\n- Dual antiplatelet therapy (i.e., acetylsalicylic acid in combination with thienopyridines [clopidogrel, prasugrel, ticlopidine or ticagrelor]) or oral anticoagulants (i.e., warfarin, dabigatran, etexilate, rivaroxaban, apixaban)\n- Unwillingness to undergo upper gastrointestinal endoscopy with biopsy at Baseline Visit A and Final/Withdrawal Visit\n- Unwillingness to ingest SIGE bars through run-in and treatment period"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in CDSD GI Specific Symptom Score (diarrhoea, abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15).","definition_or_measurement_approach":"Measured using the Celiac Disease Symptom Diary (CDSD) GI Specific Symptom Score; change from Baseline Visit B (V2, Week 3) to Visit V5 (Week 15)."}

Secondary endpoints

  • {"endpoint_text":"- Change in VH: CrD from Baseline Visit A (V1, Wk 0) to V5 (Wk 15),","definition_or_measurement_approach":"Measured by duodenal mucosal morphometry (villous height to crypt depth, VH:CrD) from biopsies taken at Baseline Visit A to V5 (Week 15)."}
  • {"endpoint_text":"- Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15),","definition_or_measurement_approach":"Measured using the CDSD Non-Stool GI Symptom Score; change from Baseline Visit B (V2, Week 3) to Visit V5 (Week 15)."}
  • {"endpoint_text":"- Change in duodenal mucosal inflammation measured as the density of CD3-positive intraepithelial lymphocytes (IELs) from Baseline Visit A (V1, Wk 0) to V5 (Wk 15).","definition_or_measurement_approach":"Measured as density of CD3-positive intraepithelial lymphocytes (IELs) on duodenal biopsy specimens from Baseline Visit A to V5 (Week 15)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
253
Recruitment Window Months
39
Consent Approach
Signed informed consent is required from each participant (adults aged 18–80). Subject information and informed consent forms (L1_SIS and ICF) are provided and country/language-specific ICF versions are available (examples in German/Austria, Polish, Finnish, English, Romanian, German). Pregnant-subject-specific information documents are provided where applicable. Consent is provided by the participant (no assent for minors, as minors are excluded).

Methods

  • Digital marketing and online patient outreach (Trialbee digital marketing content, patient website content) targeting patients with celiac disease in participating countries.
  • Online advertisements and recruitment materials (K2_Recruitment material_Advertisement, K3_Recruitment material_Advertisement) including country-specific advertisement text.
  • Patient website content and trial landing pages (patient website content documents) providing trial information and referral pathways.
  • Referral letters and secondary assessment communications (referral letters provided for sites) to engage clinician referrals.
  • Site-based recruitment through participating hospitals/clinics and specialist gastroenterology departments.

Geography

Total Number Of Sites
57
Total Number Of Participants
421

Spain

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
735
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Gastroenterology
Principal Investigator Name
Laura Crespo Pérez
Principal Investigator Email
lcreper@yahoo.es
Contact Person Name
Laura Crespo Pérez
Contact Person Email
lcreper@yahoo.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Digestive
Principal Investigator Name
Sergio Farrais Villalba
Principal Investigator Email
sfarraisv@quironsalud.es
Contact Person Name
Sergio Farrais Villalba
Contact Person Email
sfarraisv@quironsalud.es

Austria

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
711
Number Of Sites
3
Number Of Participants
19

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
UH for Internal Medicine I (Gastroenterology, Endocrinology, Metabolism and Hepatology)
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
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Division of Internal Medicine and Gastroenterology
Principal Investigator Name
Markus Peck-Radosavljevic
Principal Investigator Email
markus@peck.at
Contact Person Name
Markus Peck-Radosavljevic
Contact Person Email
markus@peck.at
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Principal Investigator Name
Lili Kazemi-Shirazi
Principal Investigator Email
Lili.kazemi-shirazi@meduniwien.ac.at
Contact Person Name
Lili Kazemi-Shirazi

Norway

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
720
Number Of Sites
5
Number Of Participants
35

Sites

Site Name
Sykehuset Innlandet HF
Department Name
Gastroenterology
Principal Investigator Name
Øistein Hovde
Principal Investigator Email
Oistein.Hovde@sykehuset-innlandet.no
Contact Person Name
Øistein Hovde
Site Name
Oslo University Hospital HF
Department Name
Gastroenterology
Principal Investigator Name
Knut Lundin
Principal Investigator Email
hanna.andreassen@medisin.uio.no
Contact Person Name
Knut Lundin
Site Name
Helse Moere Og Romsdal HF
Department Name
Clinical Studies, Gastroenterology
Principal Investigator Name
Dag Arne Hoff
Principal Investigator Email
postmottak@helse-mr.no
Contact Person Name
Dag Arne Hoff
Contact Person Email
postmottak@helse-mr.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
NorTrials Gastrointestinal
Principal Investigator Name
Rasmus Goll
Principal Investigator Email
rasmus.goll@unn.no
Contact Person Name
Rasmus Goll
Contact Person Email
rasmus.goll@unn.no
Site Name
Lovisenberg Diakonale Sykehus AS
Department Name
Unger-Vetlesen Institute
Principal Investigator Name
Jørgen Valeur
Principal Investigator Email
post@lds.no
Contact Person Name
Jørgen Valeur
Contact Person Email
post@lds.no

Poland

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
728
Number Of Sites
13
Number Of Participants
138

Sites

Site Name
Gastromed Sp. z o.o.
Principal Investigator Name
Adam Kopoń
Principal Investigator Email
adamkopon@interia.pl
Contact Person Name
Adam Kopoń
Contact Person Email
adamkopon@interia.pl
Site Name
Synexus Polska Sp. z o.o. (Katowice)
Department Name
Katowice
Principal Investigator Name
Magdalena Olszanecka-Glinianowicz
Contact Person Name
Magdalena Olszanecka-Glinianowicz
Site Name
Mtz Clinical Research Powered By Pratia
Department Name
MTZ Clinical Research powered by Pratia, Warszawa
Principal Investigator Name
Maciej Murawski
Principal Investigator Email
badacz@pratia.pl
Contact Person Name
Maciej Murawski
Contact Person Email
badacz@pratia.pl
Site Name
Futuremeds Sp. z o.o. (Cracow)
Department Name
Future Meds Sp. z o. o.
Principal Investigator Name
Piotr Rozpondek
Principal Investigator Email
potr.rozpondek@futuremeds.com
Contact Person Name
Piotr Rozpondek
Contact Person Email
potr.rozpondek@futuremeds.com
Site Name
Planetmed Sp. z o.o.
Department Name
Gastroenterology
Principal Investigator Name
Barbara Woźniak-Stolarska
Principal Investigator Email
Basiastolarska@interia.pl
Contact Person Name
Barbara Woźniak-Stolarska
Contact Person Email
Basiastolarska@interia.pl
Site Name
Synexus Polska Sp. z o.o. (Czestochowa)
Department Name
Centrum Medyczne Synexus
Principal Investigator Name
Jarosław Ziemba
Principal Investigator Email
Jaroslaw.ziemba@globalaes.com
Contact Person Name
Jarosław Ziemba
Contact Person Email
Jaroslaw.ziemba@globalaes.com
Site Name
Futuremeds Sp. z o.o. (Wroclaw Legnicka)
Department Name
Future Meds Sp. z o. o.
Principal Investigator Name
Szymon Wieczorek
Principal Investigator Email
szymon.wieczorek@futuremeds.com
Contact Person Name
Szymon Wieczorek
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
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
Synexus Polska Sp. z o.o. (Warsaw Domaniewska)
Department Name
Warsaw
Principal Investigator Name
Katarzyna Wierzbicka
Principal Investigator Email
Katarzyna.wierzbicka@globalaes.com
Contact Person Name
Katarzyna Wierzbicka
Site Name
Synexus Polska Sp. z o.o. (Poznan)
Department Name
Poznan
Principal Investigator Name
Magdalena Andrzejewska
Principal Investigator Email
Magdalena.andrzejewska@globalaes.com
Contact Person Name
Magdalena Andrzejewska
Site Name
Medical Network Sp. z o.o.
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@wip.waw.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@wip.waw.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Department Name
Gastroenterology
Principal Investigator Name
Lukasz Wolanski
Principal Investigator Email
Lancius@poczta.onet.pl
Contact Person Name
Lukasz Wolanski
Contact Person Email
Lancius@poczta.onet.pl
Site Name
Korczowski Bartosz, Gabinet Lekarski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl

Sweden

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
728
Number Of Sites
4
Number Of Participants
55

Sites

Site Name
CTC Clinical Trial Consultants AB
Department Name
Clinical trials
Principal Investigator Name
Kaveh Azizi
Principal Investigator Email
kaveh.azizi@ctc-ab.se
Contact Person Name
Kaveh Azizi
Contact Person Email
kaveh.azizi@ctc-ab.se
Site Name
Ladulaas AB
Department Name
Clinical trials
Principal Investigator Name
Katarina Berndtsson Blom
Principal Investigator Email
info@ladulaaskliniken.se
Contact Person Name
Katarina Berndtsson Blom
Contact Person Email
info@ladulaaskliniken.se
Site Name
Carlanderska Sjukhuset
Department Name
Research unit Carlanderska
Principal Investigator Name
Kaj Stenlöf
Principal Investigator Email
kaj.stenlof@carlanderska.se
Contact Person Name
Kaj Stenlöf
Contact Person Email
kaj.stenlof@carlanderska.se
Site Name
CTC Clinical Trial Consultants AB (Uppsala)
Department Name
Clinical trials
Principal Investigator Name
Sonia Jonsson
Principal Investigator Email
sonia.jonsson@ctc-ab.se
Contact Person Name
Sonia Jonsson
Contact Person Email
sonia.jonsson@ctc-ab.se

Finland

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
729
Number Of Sites
5
Number Of Participants
52

Sites

Site Name
Tampere University Hospital
Department Name
Clinical Trials
Principal Investigator Name
Juha Taavela
Principal Investigator Email
juha.taavela@tuni.fi
Contact Person Name
Juha Taavela
Contact Person Email
juha.taavela@tuni.fi
Site Name
StudyCor Oy
Department Name
Clinical Trials
Principal Investigator Name
Inka Koskinen
Principal Investigator Email
inka.koskinen@fimnet.fi
Contact Person Name
Inka Koskinen
Contact Person Email
inka.koskinen@fimnet.fi
Site Name
Clinical Research Services Turku CRST Oy
Department Name
Clinical Trials
Principal Investigator Name
Max Kiugel
Principal Investigator Email
max.kiugel@crst.fi
Contact Person Name
Max Kiugel
Contact Person Email
max.kiugel@crst.fi
Site Name
Lääkärikeskus Aava Kamppi
Department Name
Clinical Trials
Principal Investigator Name
Jari Koskenpato
Principal Investigator Email
jari.koskenpato@aava.fi
Contact Person Name
Jari Koskenpato
Contact Person Email
jari.koskenpato@aava.fi
Site Name
Suomen Terveystalo Oy
Department Name
Clinical Trials
Principal Investigator Name
Mikko Kärppä
Principal Investigator Email
mikko.karppa@oulu.fi
Contact Person Name
Mikko Kärppä
Contact Person Email
mikko.karppa@oulu.fi

Croatia

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
729
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Poliklinika Borzan d.o.o.
Department Name
/
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
vborzan@hotmail.com
Contact Person Name
Vladimir Borzan
Contact Person Email
vborzan@hotmail.com
Site Name
Poliklinika Solmed d.o.o.
Department Name
Gastroenterology
Principal Investigator Name
Dominik Kralj
Principal Investigator Email
dominik.kralj@solmed-clinic.com
Contact Person Name
Dominik Kralj
Site Name
Zadar General Hospital
Department Name
Gastroenterology
Principal Investigator Name
Melanija Ražov Radas
Principal Investigator Email
melanijarr@gmail.com
Contact Person Name
Melanija Ražov Radas
Contact Person Email
melanijarr@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
733
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Internal Medicine 3
Principal Investigator Name
Dan Dumitrascu
Principal Investigator Email
ddumitrascu@umfcluj.ro
Contact Person Name
Dan Dumitrascu
Contact Person Email
ddumitrascu@umfcluj.ro
Site Name
Tvm Med Serv S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Alina Tantau
Principal Investigator Email
office@doctortantau.ro
Contact Person Name
Alina Tantau
Contact Person Email
office@doctortantau.ro
Site Name
Hightech Medical Services S.R.L.
Department Name
Diabetes, Nutrition and Metabolic Diseases
Principal Investigator Name
Ciprian Constantin
Principal Investigator Email
ciprian_constantin@yahoo.com
Contact Person Name
Ciprian Constantin
Contact Person Email
ciprian_constantin@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
09-01-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
808
Number Of Sites
19
Number Of Participants
80

Sites

Site Name
Klinikum Chemnitz gGmbH
Department Name
Center for Internal Medicine II
Principal Investigator Name
Thaddeus Wissniowski
Principal Investigator Email
t.wissniowski@skc.de
Contact Person Name
Thaddeus Wissniowski
Contact Person Email
t.wissniowski@skc.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medical Clinic III
Principal Investigator Name
Alexander Koch
Principal Investigator Email
akoch@ukaachen.de
Contact Person Name
Alexander Koch
Contact Person Email
akoch@ukaachen.de
Site Name
Universitaet Leipzig
Department Name
Clinic and polyclinic for oncology, gastroenterology, hepatology, pulmonology and infectiology
Principal Investigator Name
Albrecht Hoffmeister
Contact Person Name
Albrecht Hoffmeister
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Department of Medicine 1, Hector-Center
Principal Investigator Name
Yurdaguel Zopf
Principal Investigator Email
Yurdaguel.zopf@uk-erlangen.de
Contact Person Name
Yurdaguel Zopf
Contact Person Email
Yurdaguel.zopf@uk-erlangen.de
Site Name
Universitat Heidelberg
Department Name
Medical Clinic II
Principal Investigator Name
Wolfgang Reindl
Principal Investigator Email
Wolfgang.reindl@umm.de
Contact Person Name
Wolfgang Reindl
Contact Person Email
Wolfgang.reindl@umm.de
Site Name
Universitaet Muenster
Department Name
Medical Clinic B
Principal Investigator Name
Jonel Trebicka
Principal Investigator Email
jonel.trebicka@ukmuenster.de
Contact Person Name
Jonel Trebicka
Contact Person Email
jonel.trebicka@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Gastroenterology, Hepatology, Transplantmedicine
Principal Investigator Name
Jan Best
Principal Investigator Email
Jan.Best@uk-essen.de
Contact Person Name
Jan Best
Contact Person Email
Jan.Best@uk-essen.de
Site Name
Medizinische Hochschule Hannover
Department Name
Dept. of Gastroenterology Hepatology and Endocrinology
Principal Investigator Name
Heiner Wedemeyer
Principal Investigator Email
wedemeyer.heiner@mh-hannover.de
Contact Person Name
Heiner Wedemeyer
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Institute for Translational Immunology
Principal Investigator Name
Detleff Schuppan
Principal Investigator Email
detlef.schuppan@unimedizin-mainz.de
Contact Person Name
Detleff Schuppan
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Gastroenterology
Principal Investigator Name
Michael Schumann
Principal Investigator Email
michael.schumann@charite.de
Contact Person Name
Michael Schumann
Contact Person Email
michael.schumann@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medical Clinic, Internal Medicine 1, Gastroenterology, Hepatology, infectology
Principal Investigator Name
Karsten Bueringer
Principal Investigator Email
Karsten.Bueringer@med.uni-tuebingen.de
Contact Person Name
Karsten Bueringer
Site Name
Romed Klinikum Rosenheim
Department Name
Department of Internal Medicine II
Principal Investigator Name
Joerg Felber
Principal Investigator Email
joerg.felber@ro-med.de
Contact Person Name
Joerg Felber
Contact Person Email
joerg.felber@ro-med.de
Site Name
Siloah St Trudpert Klinikum
Department Name
Department for internal medicine 1
Principal Investigator Name
Oliver Bachmann
Principal Investigator Email
Oliver.bachmann@siloah.de
Contact Person Name
Oliver Bachmann
Contact Person Email
Oliver.bachmann@siloah.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Gastroenterology, Hepatology, Endocrinology & nutrition
Principal Investigator Name
Johann Ockenga
Principal Investigator Email
Johann.Ockenga@Klinikum-Bremen-Mitte.de
Contact Person Name
Johann Ockenga
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Internal Medicine and Gastroenterology
Principal Investigator Name
Sina Hubener
Principal Investigator Email
s.huebener@uke.de
Contact Person Name
Sina Hubener
Contact Person Email
s.huebener@uke.de
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Medicine 2, Gastroenterology, Hepatology, Infection & Endocrinology
Principal Investigator Name
Peter Hasselblatt
Principal Investigator Email
peter.hasselblatt@uniklinik-freiburg.de
Contact Person Name
Peter Hasselblatt
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Centre For Internal Medicine, Internal Medicine 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
Klinikum der Universitaet Muenchen AöR
Department Name
Medical Clinic II
Principal Investigator Name
Helga Toeroek
Principal Investigator Email
Helga.Toeroek@med.uni-muenchen.de
Contact Person Name
Helga Toeroek
Site Name
Universitaetsklinikum Jena KöR
Department Name
Department for Internal medicine IV
Principal Investigator Name
Kathleen Sabine Lange
Principal Investigator Email
Kathleen.lange@med.uni-jena.de
Contact Person Name
Kathleen Sabine Lange
Contact Person Email
Kathleen.lange@med.uni-jena.de

Sponsor

Primary sponsor

Full Name
Dr. Falk Pharma GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
RTI Health Solutions
Responsibilities
Optional exit interviews
Name
Trialbee
Responsibilities
Patient recruitment / digital recruitment activities
Name
Optimapharm d.o.o.
Responsibilities
Operational sponsor duties (codes listed in CTIS record)

Third parties

  • {"country":"United States","full_name":"RTI Health Solutions","duties_or_roles":"A third party responsible for optional exit interviews.","organisation_type":"Industry"}
  • {"country":"Sweden","full_name":"Trialbee","duties_or_roles":"Patient recruitment","organisation_type":"Industry"}
  • {"country":"Croatia","full_name":"Optimapharm d.o.o.","duties_or_roles":"Sponsor duties codes present (1,10,11,12,13,14,2,5,6,7,8,9) as listed in CTIS record","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Jilab Oy","duties_or_roles":"Sponsor duties code 4 (as listed)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"Sponsor duties code 4 (as listed)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"NextPharma GmbH","duties_or_roles":"Packaging and Dispensing of IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Storage of biological samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"National Foodworks Services LLC","duties_or_roles":"Manufacturing of SIGE Bars","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"A&M Labor fuer Analytik und Metabolismusforschung Service GmbH","duties_or_roles":"pharmacokinetics and laboratory testing (as listed)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
CEC03
Active Substance
METHYL (E,6S)-7-[[1-[2-(2-ETHYLBUTYLAMINO)-2-OXOETHYL]-2-OXOPYRIDIN-3-YL]AMINO]-6-[(3-METHYLIMIDAZOLE-4-CARBONYL)AMINO]-7-OXOHEPT-2-ENOATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Investigational Product Name
CEC02
Active Substance
METHYL (E,6S)-7-[[1-[2-(2-ETHYLBUTYLAMINO)-2-OXOETHYL]-2-OXOPYRIDIN-3-YL]AMINO]-6-[(3-METHYLIMIDAZOLE-4-CARBONYL)AMINO]-7-OXOHEPT-2-ENOATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
1
Investigational Product Name
Placebo matching with ZED1227 capsules of Dr. Falk Pharma GmbH
Modality
Other
Routes Of Administration
ORAL USE
Route
ORAL

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