Clinical trial • Phase II • Gastroenterology

MT-501 for Crohn's disease | Ulcerative colitis

Phase II trial of MT-501 for Crohn's disease | Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease | Ulcerative colitis
Trial Stage
Phase II
Drug Modality
Small molecule | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
07-07-2025
First CTIS Authorization Date
20-10-2025

Trial design

Randomised, placebo for mt-501, film coated tablets (dose and schedule not specified)-controlled Phase II trial in Belgium, Italy, Bulgaria and others.

Randomised
Yes
Comparator
Placebo for MT-501, film coated tablets (dose and schedule not specified)

Eligibility

Recruits 54 Vulnerable population selected. Participants must be able to provide written informed consent and understand and comply with study requirements; legal or mental incapacitation or inability to understand and comply is an exclusion. Prisoners/compulsorily detained participants are explicitly excluded..

Pregnancy Exclusion
Women who are pregnant or breastfeeding.
Vulnerable Population
Vulnerable population selected. Participants must be able to provide written informed consent and understand and comply with study requirements; legal or mental incapacitation or inability to understand and comply is an exclusion. Prisoners/compulsorily detained participants are explicitly excluded.

Inclusion criteria

  • {"criterion_text":"- ≥ 18 to ≤ 80 years old.\n- UC: Moderately to severely active UC.\n- UC: Participants must meet drug stabilization requirements.\n- Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA.\n- Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD.\n- Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA.\n- CD: Documented diagnosis of CD.\n- CD: Moderately to severely active CD as defined by CDAI.\n- CD: SES-CD (per central reading) consistent with moderate to severely active CD.\n- CD: Participants must meet drug stabilization requirements.\n- UC: Documented diagnosis of UC."}

Exclusion criteria

  • {"criterion_text":"- Women who are pregnant or breastfeeding.\n- Participants with any serious bacterial infection within 3 months prior to Screening.\n- Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.\n- Stool positive for Clostridioides difficile (C. difficile) infection.\n- Clinically significantly abnormal laboratory values.\n- Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.\n- Allergy to intervention or any of the excipients.\n- CD patients: Diagnosis of indeterminate colitis.\n- CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening.\n- CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch.\n- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.\n- CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.\n- CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.\n- UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.\n- UC patients: Previous total proctocolectomy or subtotal colectomy.\n- Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.\n- Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.\n- Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.\n- Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study.\n- Participants with concomitant primary sclerosing cholangitis.\n- Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection).\n- Participants at risk for tuberculosis (TB)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values","definition_or_measurement_approach":"Assess proportion of participants reporting TEAEs, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values (as reported during study follow-up)."}
  • {"endpoint_text":"- Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase","definition_or_measurement_approach":"Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of Induction Phase using prospective observer-blinded endpoint assessments."}
  • {"endpoint_text":"- Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase","definition_or_measurement_approach":"Assess the proportion of participants with clinical remission at end of Induction Phase in randomized placebo-controlled ISAs."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants with clinical remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants with clinical remission at end of Induction Phase."}
  • {"endpoint_text":"- CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase","definition_or_measurement_approach":"Assess proportion with endoscopic response (CD) or endoscopic improvement (UC) at end of Induction Phase."}
  • {"endpoint_text":"- Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants achieving PRO-2 remission at end of Induction Phase."}
  • {"endpoint_text":"- Proportion of participants with clinical response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants with clinical response at end of Induction Phase."}
  • {"endpoint_text":"- CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of CD participants with both endoscopic and clinical response at end of Induction Phase."}
  • {"endpoint_text":"- UC: Proportion of participants with histologic response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with histologic response at end of Induction Phase."}
  • {"endpoint_text":"- UC: Proportion of participants with histologic remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with histologic remission at end of Induction Phase."}
  • {"endpoint_text":"- UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with combined histologic-endoscopic mucosal improvement at end of Induction Phase."}
  • {"endpoint_text":"- CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase","definition_or_measurement_approach":"Characterize change in endoscopy scores (SES-CD for CD; MES for UC) from Day 1 to end of Induction Phase."}
  • {"endpoint_text":"- CD: Change in Global Histologic Activity Score (GHAS) and RHI from Day 1 to end of Induction Phase UC: Change in Geboes score, RHI, and Nancy Histological Index (NHI) from Day 1 to end of Induction Phase Descriptive summaries of PK of investigational drug","definition_or_measurement_approach":"Characterize change in histology scores (GHAS, RHI for CD; Geboes, RHI, NHI for UC) from Day 1 to end of Induction Phase; includes descriptive PK summaries."}
  • {"endpoint_text":"- Descriptive summaries of PK of investigational drug","definition_or_measurement_approach":"Provide descriptive summaries of pharmacokinetics (PK) of investigational drug."}

Recruitment

Planned Sample Size
54
Recruitment Window Months
18
Consent Approach
Written informed consent is required; participants must be able to provide written informed consent and understand study requirements. Subject information sheets and informed consent forms are provided (multiple language / country-specific versions are listed in the documentation: examples include EN, BG, CZ, DE, IT, SK, PL, BE-FR, BE-NL, HR). Only adults (≥18 years) are eligible; no assent procedures are indicated.

Methods

  • Physician-to-physician referral letters (documented in recruitment materials K2_Physician to Physician Referral Letter).
  • Patient referral contact letters (K2_Recruitment material description_Patient Referral Contact letter).
  • GP letters (L2_Other subject information_GP Letter_Redacted).
  • Recruitment and Informed Consent Procedure documents (K1_Recruitment and Informed consent procedure) provided per Member State.

Geography

Total Number Of Sites
40
Total Number Of Participants
54

Belgium

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
224
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Imelda
Department Name
Gastroenterology
Principal Investigator Name
Peter Bossuyt
Principal Investigator Email
peter.bossuyt@imelda.be
Contact Person Name
Peter Bossuyt
Contact Person Email
peter.bossuyt@imelda.be
Site Name
UZ Leuven
Department Name
Gastroenterology
Principal Investigator Name
Bram Verstockt
Principal Investigator Email
bram.verstockt@uzleuven.be
Contact Person Name
Bram Verstockt
Contact Person Email
bram.verstockt@uzleuven.be
Site Name
University Of Antwerp
Department Name
Gastroenterology/Hepatology
Principal Investigator Name
Elisabeth Macken
Principal Investigator Email
elisabeth.macken@uza.be
Contact Person Name
Elisabeth Macken
Contact Person Email
elisabeth.macken@uza.be

Italy

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
202
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Department of Medical Sciences, SC Gastroenterology Unit
Principal Investigator Name
Ribaldone Davide Giuseppe
Principal Investigator Email
davidegiuseppe.ribaldone@unito.it
Contact Person Name
Ribaldone Davide Giuseppe
Site Name
Humanitas Mirasole S.p.A.
Department Name
Operative Unit Inflammatory Bowel Diseases
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC CEMAD - Center for Digestive System Diseases
Principal Investigator Name
Lucrezia Laterza
Principal Investigator Email
lucrezia.laterza@policlinicogemelli.it
Contact Person Name
Lucrezia Laterza
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Department of Gastroenterology and Gastrointestinal Endoscopy
Principal Investigator Name
Silvio Danese
Principal Investigator Email
DANESE.SILVIO@HSR.IT
Contact Person Name
Silvio Danese
Contact Person Email
DANESE.SILVIO@HSR.IT

Bulgaria

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
207
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Principal Investigator Name
Dimitar Dimitrov
Principal Investigator Email
dr.dimitar.dimitrov.md@gmail.com
Contact Person Name
Dimitar Dimitrov
Site Name
Purva Chastna Mbal EOOD Vratsa
Department Name
Department of Internal Medicine
Principal Investigator Name
Dobromir Dragoychev
Principal Investigator Email
dr_dragoichev@abv.bg
Contact Person Name
Dobromir Dragoychev
Contact Person Email
dr_dragoichev@abv.bg
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Department of Internal Medicine
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
ikosturkov@mcmedicaplus.com
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com

Germany

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
199
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Krankenhaus Waldfriede e.V.
Department Name
Innere Medizin
Principal Investigator Name
Carsten Buening
Principal Investigator Email
c.buening@waldfriede.de
Contact Person Name
Carsten Buening
Contact Person Email
c.buening@waldfriede.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik I
Principal Investigator Name
Karsten Bueringer
Principal Investigator Email
zks-pm@med.uni-tuebingen.de
Contact Person Name
Karsten Bueringer
Contact Person Email
zks-pm@med.uni-tuebingen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Principal Investigator Name
Christoph Jochum
Principal Investigator Email
christoph.jochum@charite.de
Contact Person Name
Christoph Jochum
Contact Person Email
christoph.jochum@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Centre for Internal Medicine, Internal Medicine 1
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
Magen-Darm-Zentrum-Remscheid
Principal Investigator Name
Eric Joergensen
Principal Investigator Email
info@mdz-remscheid.de
Contact Person Name
Eric Joergensen
Contact Person Email
info@mdz-remscheid.de

Slovakia

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
194
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Endomed s.r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Miroslav Fedurco
Principal Investigator Email
fedurco@endomed.sk
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
II. interná klinika, gastroenterologická ambulancia
Principal Investigator Name
Jozef Baláž
Principal Investigator Email
balaz78@gmail.com
Contact Person Name
Jozef Baláž
Contact Person Email
balaz78@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
196
Number Of Sites
16
Number Of Participants
21

Sites

Site Name
Vistamed & Vertigo Sp. z o.o.
Department 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
Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska
Principal Investigator Name
Michał Walczak
Principal Investigator Email
michal.walczak@clinsante.pl
Contact Person Name
Michał Walczak
Contact Person Email
michal.walczak@clinsante.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
PRYWATNA LECZNICA "CERTUS" SZPITAL NR 1; PRYWATNA LECZNICA CERTUS AMBULATORIA
Principal Investigator Name
Piotr Szabłowski
Principal Investigator Email
szapi@mp.pl
Contact Person Name
Piotr Szabłowski
Contact Person Email
szapi@mp.pl
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
Vita Longa Sp. z o.o.
Department Name
NZOZ Vita Longa
Principal Investigator Name
Przemysław Ramos
Principal Investigator Email
przemyslaw.ramos@researchsolutions.pl
Contact Person Name
Przemysław Ramos
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
EMC Instytut Medyczny S.A. (Wroclaw site)
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
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkuś
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Centrum Medyczne Oporow
Principal Investigator Name
Radosław Kempiński
Principal Investigator Email
radoslaw.kempinski@cmoporow.com
Contact Person Name
Radosław Kempiński
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
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
Eb Group Sp. z o.o.
Department Name
Centrum Zdrowia MDM
Principal Investigator Name
Miłosz Jastrzębski
Principal Investigator Email
milosz.jastrzebski@czmdm.pl
Contact Person Name
Miłosz Jastrzębski
Contact Person Email
milosz.jastrzebski@czmdm.pl
Site Name
Centrum Medyczne Med-Gastr Sp. z o.o.
Principal Investigator Name
Arkadiusz Mamos
Principal Investigator Email
amamos@wp.pl
Contact Person Name
Arkadiusz Mamos
Contact Person Email
amamos@wp.pl
Site Name
Endoskopia Sp. z o.o.
Principal Investigator Name
Marek Horyński
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Marek Horyński
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Principal Investigator Name
Jacek Kiełtucki
Principal Investigator Email
jacek.kieltucki@nowezdrowie-ck.pl
Contact Person Name
Jacek Kiełtucki
Site Name
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Department Name
HT 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

Croatia

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
294
Number Of Sites
4
Number Of Participants
4

Sites

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
Specijalna Bolnica Medico
Department Name
Gastroenterology
Principal Investigator Name
Boris Brozovic
Principal Investigator Email
borisbrozovic@yahoo.com
Contact Person Name
Boris Brozovic
Contact Person Email
borisbrozovic@yahoo.com
Site Name
Poliklinika Solmed d.o.o.
Department Name
Gastroenterology
Principal Investigator Name
Dominik Kralj
Principal Investigator Email
dominik.rex@gmail.com
Contact Person Name
Dominik Kralj
Contact Person Email
dominik.rex@gmail.com
Site Name
Poliklinika Borzan d.o.o.
Department Name
Gastroenterology
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
vborzan@hotmail.com
Contact Person Name
Vladimir Borzan
Contact Person Email
vborzan@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
201
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
SurGal Clinic s.r.o.
Department Name
Oddělení chirurgie
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
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
Site Name
Nemocnice Prachatice a.s.
Department Name
Gastroenterologická ambulance
Principal Investigator Name
Pavel Lipták
Principal Investigator Email
pavel.liptak@nempt.cz
Contact Person Name
Pavel Lipták
Contact Person Email
pavel.liptak@nempt.cz

Sponsor

Primary sponsor

Full Name
Mirador Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Psi Cro AG
Responsibilities
Sponsor duties codes: 1, 12 (as listed in CTIS third party entries)

Third parties

  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"[1,12]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MT-501
Active Substance
MT-501
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Investigational Product Name
MT-201
Active Substance
MT-201
Modality
Peptide/protein/enzyme
Routes Of Administration
PARENTERAL USE
Route
PARENTERAL USE
Investigational Product Name
Placebo for MT-501, film coated tablets
Modality
Other

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