Clinical trial • Phase II • Gastroenterology

DUVAKITUG for Crohn's disease | Ulcerative colitis

Phase II trial of DUVAKITUG for Crohn's disease | Ulcerative colitis.

Overview

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

Key dates

Initial CTIS Submission Date
27-08-2024
First CTIS Authorization Date
24-09-2024

Trial design

Randomised, open-label, tev-48574 dose a (subcutaneous, dose regimen a, administered q4w) versus tev-48574 dose b (subcutaneous, dose regimen b, administered q4w).-controlled Phase II trial in Bulgaria, Spain, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
TEV-48574 Dose A (subcutaneous, Dose regimen A, administered Q4W) versus TEV-48574 Dose B (subcutaneous, Dose regimen B, administered Q4W).
Target Sample Size
70
Trial Duration For Participant
309

Eligibility

Recruits 70 adults.

Pregnancy Exclusion
4. The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.

Inclusion criteria

  • {"criterion_text":"- 1.Maintenance Period: Adults of male and female sex (without restrictions based on gender) who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. OLE Period: Adults of male and female sex (without restrictions based on gender) who have clinical response and/or clinical remission at week 44 of the maintenance period of this study."}
  • {"criterion_text":"- 2. Re-induction Period: Adults of male and female sex (without restrictions based on gender) who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study"}

Exclusion criteria

  • {"criterion_text":"- 1.Patients who discontinued the DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)."}
  • {"criterion_text":"- 2. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician."}
  • {"criterion_text":"- 3. Patient anticipates requiring major surgery during this study."}
  • {"criterion_text":"- 4. The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 44 in patients with UC","definition_or_measurement_approach":"Clinical remission assessed at week 44 using modified 9-point Mayo score: stool frequency subscore 0 or 1, rectal bleeding subscore 0, and endoscopic subscore 0 or 1 (score of 1 excludes friability)."}
  • {"endpoint_text":"- 2. Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) of at least 50% from dose-range finding (DRF) study baseline at week 44 in patients with CD","definition_or_measurement_approach":"Endoscopic response at week 44 in CD defined as ≥50% decrease in SES-CD versus DRF study baseline."}

Secondary endpoints

  • {"endpoint_text":"- 1. Clinical response, based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF study baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1 at week 44 in patients with UC","definition_or_measurement_approach":"Clinical response at week 44 for UC: ≥2 point improvement on modified Mayo score AND ≥30% reduction from DRF baseline with either ≥1 decrease in rectal bleeding subscore or absolute rectal bleeding subscore ≤1."}
  • {"endpoint_text":"- 2. Endoscopic improvement from DRF study baseline based on Mayo endoscopic subscore of 0 or 1 at week 44 in patients with UC","definition_or_measurement_approach":"Endoscopic improvement at week 44 for UC defined as Mayo endoscopic subscore 0 or 1 versus DRF baseline."}
  • {"endpoint_text":"- 3. Endoscopic remission based on Mayo endoscopic subscore of 0 at week 44 in patients with UC","definition_or_measurement_approach":"Endoscopic remission at week 44 for UC defined as Mayo endoscopic subscore = 0."}
  • {"endpoint_text":"- 4. Corticosteroid-free clinical remission based on the modified Mayo score at week 44, defined by clinical remission (see primary endpoint) and corticosteroid free for ≥12 weeks preceding week 44, in patients with UC.","definition_or_measurement_approach":"Clinical remission (as primary endpoint) at week 44 plus corticosteroid-free for ≥12 weeks prior to week 44 for UC patients."}
  • {"endpoint_text":"- 5. Clinical response based on Crohn’s Disease Activity Index (CDAI): ≥100-point decrease in CDAI score from DRF study baseline in patients with CD at week 44","definition_or_measurement_approach":"Clinical response for CD at week 44 defined as ≥100-point decrease in CDAI versus DRF baseline."}
  • {"endpoint_text":"- 6. Clinical remission based on CDAI score <150 at week 44 in patients with CD","definition_or_measurement_approach":"Clinical remission for CD at week 44 defined as CDAI <150."}
  • {"endpoint_text":"- 7. Corticosteroid-free endoscopic response based on SES-CD at week 44, defined by endoscopic response (see primary endpoint) and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD","definition_or_measurement_approach":"Endoscopic response (≥50% SES-CD decrease) at week 44 plus corticosteroid-free for ≥12 weeks prior to week 44 for CD patients."}
  • {"endpoint_text":"- 8. Corticosteroid-free clinical remission based on CDAI at week 44, defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD","definition_or_measurement_approach":"CDAI <150 at week 44 plus corticosteroid-free for ≥12 weeks prior to week 44 for CD patients."}
  • {"endpoint_text":"- 9. Adverse events Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions","definition_or_measurement_approach":"Safety assessed by recording adverse events including clinically significant lab changes (serum chemistry, hematology, urinalysis), vital signs, 12-lead ECG changes, and injection site reactions."}
  • {"endpoint_text":"- 10. Patients who stopped the investigational medicinal product due to adverse events","definition_or_measurement_approach":"Count of patients discontinuing IMP because of adverse events during the study."}
  • {"endpoint_text":"- 11. Treatment-emergent anti-drug antibody (ADA)","definition_or_measurement_approach":"Assessment of treatment-emergent anti-drug antibodies (ADA) during the study."}
  • {"endpoint_text":"- 12. Neutralizing ADA in ADA positive patients throughout the study","definition_or_measurement_approach":"Assessment of neutralizing ADA in patients who are ADA-positive during the study."}

Recruitment

Planned Sample Size
70
Recruitment Window Months
90
Consent Approach
Informed consent obtained from adult participants. Subject information sheets and informed consent forms (L1_SIS and ICF) are provided in multiple languages (examples in the dossier: English, Bulgarian, Hungarian, Spanish, Polish, Czech, Slovak, German, Italian, Norwegian and others) including specific pregnancy information and optional pharmacogenetics/FSR consent forms. No paediatric assent described.

Geography

Total Number Of Sites
57
Total Number Of Participants
184

Bulgaria

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Contact Person Name
Dimitar Dimitrov
Contact Person Email
dimitar.dimitrov.ge@gmail.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
Department of Internal Medicine
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com
Site Name
Acibadem City Clinic University Hospital EOOD
Department Name
Clinic of Gastroenterology
Contact Person Name
Asen Petrov
Contact Person Email
dr_assenp@abv.bg

Spain

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
25-09-2024
Processing Time Days
9
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Clinica Gaias Santiago
Department Name
Department of Gastroenterology
Contact Person Name
Ana Alvarez Castro
Contact Person Email
ip.digestivo@gaiasresearch.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Department of Gastroenterology
Contact Person Name
Marisa Iborra Colomino
Contact Person Email
marisaiborra@hotmail.com
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Department of Gastroenterology
Contact Person Name
Elena Gomez Delgado
Contact Person Email
eleno80@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
25-09-2024
Processing Time Days
9
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
GASTRO JeKa s.r.o.
Department Name
Gastroenterology clinic
Contact Person Name
Ondrej Jelinek
Contact Person Email
ondra.jelinek@gmail.com
Site Name
Vojenska Nemocnice Brno
Department Name
Department of Internal Medicine-gastroenterology
Contact Person Name
David Stepek
Contact Person Email
dstepek@vnbrno.cz
Site Name
Nemocnice Slany
Department Name
Department of Internal Medicine
Contact Person Name
Martin Peterka
Contact Person Email
peterka.studie@seznam.cz

Germany

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
26-09-2024
Processing Time Days
10
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Studiengesellschaft Jakobeit UG (haftungsbeschraenkt)
Department Name
Group Practice Jakobeit
Contact Person Name
Christian Jakobeit
Contact Person Email
cj@gp-jakobeit.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Medizinische  Klinik, Innere Medizin I, Gastroenterologie, Hepatologie, Infektiologie
Contact Person Name
Jochen Klaus
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik, Innere Medizin I, Gastroenterologie, Hepatologie, Infektiologie
Contact Person Name
Karsten Bueringer
Site Name
Dr. Thomas Brunk Gastroenterology
Department Name
Gastroenterology in Berlin Karlshorst
Contact Person Name
Michael Mross
Contact Person Email
dr.mross@t-online.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Stefan Schreiber
Contact Person Email
study@ikmb.uni-kiel.de

Italy

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
15
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and endoscopy unit/ ibd unit
Contact Person Name
Silvio Danese
Contact Person Email
ibd.trials@hsr.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Gastroenterology Unit
Contact Person Name
Giovanni Maconi
Contact Person Email
giovanni.maconi@unimi.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
IBD center - Centro per Malattie Infiammatorie Croniche Intestinali
Contact Person Name
Alessandro Armuzzi
Contact Person Email
clinicaltrialsibd@humanitas.it

Hungary

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
25-09-2024
Processing Time Days
9
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Clinexpert Kft.
Department Name
NA (SMO Clinexpert Ltd)
Contact Person Name
Zsanett Zsuzsanna Heringh
Contact Person Email
info@clinexpert.hu
Site Name
Javorszky Oedoen Korhaz
Department Name
Department of Gastroenterology
Contact Person Name
Tibor Szaloki
Contact Person Email
vacikorhaz@javorszky.hu
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Haematology
Contact Person Name
Zsolt Tulassay

Norway

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Akershus University Hospital
Department Name
Department of Gastroenterology
Contact Person Name
Stephan Brackmann

Austria

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
29-09-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III Div. Gastroenterology & Hepatology
Contact Person Name
Reinisch Walter

Poland

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
21
Number Of Sites
30
Number Of Participants
111

Sites

Site Name
Ip Clinic Sp. z o.o.
Contact Person Name
Cezary Rudnicki
Contact Person Email
cezary.rudnicki@ipclinic.pl
Site Name
Pro Life Medica Sp. z o.o.
Department Name
ETG Zamosc
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Szymon Wieczorek
Site Name
Synexus Polska Sp. z o.o. (Katowice)
Contact Person Name
Magdalena Olszanecka-Glinianowicz
Site Name
Sonomed Sp. z o.o.
Contact Person Name
Anna Wiechowska-Kozłowska
Site Name
Gastromed Sp. z o.o.
Contact Person Name
Marcin Zmudziński
Contact Person Email
m.zmudek2@gmail.com
Site Name
Synexus Polska Sp. z o.o. (Czestochowa)
Contact Person Name
Jaroslaw Ziemba
Contact Person Email
jaroslaw.ziemba@globalaes.com
Site Name
Synexus Polska Sp. z o.o. (Poznan)
Contact Person Name
Magdalena Andrzejewska
Site Name
Allmedica Badania Kliniczne Sp. z o.o.
Contact Person Name
Mikołaj Krzyżanowski
Contact Person Email
Mikolaj.krzyzanowski@gmail.com
Site Name
Centrum Medyczne Oporow
Contact Person Name
Radosław Kempiński
Site Name
Endoskopia Sp. z o.o.
Contact Person Name
Marek Horyński
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Contact Person Name
Jacek Kiełtucki
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Wsd Medi Clinical Sp. z o.o.
Contact Person Name
Michał Krogulecki
Contact Person Email
clinicaltrials@mediclinical.pl
Site Name
Globe Badania Kliniczne Sp. z o.o.
Contact Person Name
Mirosław Wójcik
Contact Person Email
biuro@globebadania.pl
Site Name
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
Contact Person Name
Zbigniew Wylegała
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Department Name
Gastroenterology department
Contact Person Name
Łukasz Wolański
Contact Person Email
spzoz@spzoz.powiatleczynski.pl
Site Name
Szpital Miejski Sw. Jana Pawla II W Elblagu
Department Name
Department of Internal Diseases
Contact Person Name
Krzysztof Niezgoda
Contact Person Email
krzysztof-niezgoda@wp.pl
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Monika Augustyn
Contact Person Email
office.cmplejady@gmail.com
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkus
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@wip.waw.pl
Site Name
Nzoz For Med Sp. z o.o.
Contact Person Name
Przemysław Ramos
Contact Person Email
przemyslaw.ramos@nzozformed.pl
Site Name
Synexus Polska Sp. z o.o. (Gdansk)
Contact Person Name
Marek Cesarz
Contact Person Email
marek.cesarz@globalaes.com
Site Name
Ośrodek Badań Klinicznych Clinsante s.c. Ewa Galczak-Nowak Małgorzata Trzaska
Contact Person Name
Michał Walczak
Contact Person Email
michal.walczak@clinsante.pl
Site Name
Solumed Centrum Medyczne Sp. z o.o.
Contact Person Name
Marek Karczewski
Contact Person Email
drkarczewski@gmail.com
Site Name
Specjalistyczne Gabinety Lekarskie Landa
Contact Person Name
Katarzyna Landa
Contact Person Email
landa@smo.com.pl
Site Name
EMC Instytut Medyczny S.A. (Wroclaw Wejherowska)
Department Name
Penta Hospitals Przychodnie, Wrocław Wejherowska
Contact Person Name
Patryk Smoliński
Contact Person Email
psmolinski@poczta.onet.pl
Site Name
Vistamed & Vertigo Sp. z o.o.
Contact Person Name
Bernadeta Fryśna
Contact Person Email
b.frysna@ginemedica.pl
Site Name
Eb Group Sp. z o.o.
Department Name
Centrum Zdrowia MDM/ MDM Healthcare Center
Contact Person Name
Marek Woynarowski
Contact Person Email
marek.woynarowski@czmdm.pl

Slovakia

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
8
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Endomed s.r.o.
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
Alian s.r.o.
Department Name
General Practice
Contact Person Name
Martin Molnar
Contact Person Email
molnarm@centrum.sk
Site Name
Gastro I. s.r.o.
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Bohus Bunganic
Contact Person Email
gastrobunganic@gmail.com
Site Name
Gastro LM s.r.o.
Department Name
Gastroenterology outpatient clinic
Contact Person Name
Lubomir Mihalkanin
Contact Person Email
mihalkanin@gmail.com
Site Name
Cliniq s.r.o.
Department Name
Gastroenterology outpatient clinic
Contact Person Name
Tibor Hlavaty
Contact Person Email
tibor.hlavaty2@gmail.com

Sponsor

Primary sponsor

Full Name
Teva Branded Pharmaceutical Products R&D LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Psi Cro AG
Responsibilities
Site Selection, Project Management, Study Start Up, Recruitment, Trial Master File

Third parties

  • {"country":"United States","full_name":"Teva Branded Pharmaceutical Products R&D LLC","duties_or_roles":"code 4","organisation_type":"Industry"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Serology/ endocrinology, Fecal Calprotectin Laboratory analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Teva Gyogyszergyar Zrt.","duties_or_roles":"Analysis of TL1A serum biomarker sample","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Histopathology, Primary/ surrogate endpoint test","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Biosamples Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Biosamples Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Transcriptomic analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Site Selection, Project Management, Study Start Up, Recruitment, Trial Master File","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Teva Branded Pharmaceutical Products R&D LLC","duties_or_roles":"Other - PK and ADA analysis; Analysis of TL1A tissue biomarker samples; Serum PD (Aliq B) analysis, CCL3 analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PharmaNest","duties_or_roles":"Digital Pathology of intestinal biopsies","organisation_type":"Industry"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Serum measures of GI tissue Condition","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Calyx","duties_or_roles":"Interactive response technologies (IRT)","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/ review, Patient diaries","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TEV-48574
Active Substance
DUVAKITUG
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised (prodAuthStatus=1)
Frequency
Every 4 weeks (Q4W)
Maximum Dose
900 mg daily; 2250 mg total

Related trials

Other published trials that may interest you.