Clinical trial • Phase III • Gastroenterology

TULISOKIBART for Crohn's disease | Ulcerative colitis

Phase III trial of TULISOKIBART for Crohn's disease | Ulcerative colitis.

Overview

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

Key dates

Initial CTIS Submission Date
23-09-2024
First CTIS Authorization Date
24-01-2025

Trial design

open-label, placebo to mk-7240 (tulisokibart) — comparator product listed but dosing and schedule not specified in the record-controlled Phase III trial across 22 sites in France, Hungary, Poland and others.

Open Label
Yes
Comparator
Placebo to MK-7240 (Tulisokibart) — comparator product listed but dosing and schedule not specified in the record
Target Sample Size
913
Trial Duration For Participant
364

Eligibility

Recruits 913 No vulnerable populations selected (isVulnerablePopulationSelected: false). The documentation lists standard subject information and informed consent forms; no specific assent or special vulnerable-consent procedures are indicated in the record..

Pregnancy Exclusion
A participant of childbearing potential is eligible if not pregnant and uses an acceptable form of contraception or abstinence
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). The documentation lists standard subject information and informed consent forms; no specific assent or special vulnerable-consent procedures are indicated in the record.

Inclusion criteria

  • {"criterion_text":"- Has participated in a qualifying MSD-sponsored tulisokibart Phase 2 or Phase 3 parent study for Crohn’s Disease or Ulcerative Colitis"}
  • {"criterion_text":"- The participant is judged to derive clinical benefit from continued study intervention as determined by the investigator based upon clinical evaluations performed during their parent study."}
  • {"criterion_text":"- Assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention"}
  • {"criterion_text":"- A participant of childbearing potential is eligible if not pregnant and uses an acceptable form of contraception or abstinence"}

Exclusion criteria

  • {"criterion_text":"- Has prematurely discontinued from study intervention in the parent study"}
  • {"criterion_text":"- Has met any of the protocol-specified mandatory study intervention discontinuation criteria during the LTE Screening Period; or has an ongoing SAE from the parent study; or if in the opinion of the investigator, continued study participation poses unacceptable risk to the participant"}
  • {"criterion_text":"- Has received any protocol-defined prohibited concomitant medications"}
  • {"criterion_text":"- Is currently participating in an interventional clinical study other than a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC"}
  • {"criterion_text":"- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants with ≥1 adverse event (AE)","definition_or_measurement_approach":"Proportion (%) of participants experiencing at least one adverse event (AE) as recorded during the study (measurement approach not further specified in the record)."}
  • {"endpoint_text":"- Percentage of participants discontinuing from study therapy due to AE","definition_or_measurement_approach":"Proportion (%) of participants who discontinue study therapy because of an adverse event (AE) (measurement approach not further specified in the record)."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364","definition_or_measurement_approach":"Proportion (%) of participants achieving clinical remission by CDAI at Week 364."}
  • {"endpoint_text":"- Percentage of participants achieving 2-patient-reported outcomes (PRO-2) remission per Crohn’s Disease Activity Index score at Week 364","definition_or_measurement_approach":"Proportion (%) of participants achieving PRO-2 remission at Week 364."}
  • {"endpoint_text":"- Percentage of participants achieving endoscopic remission per Simplified Endoscopic Score for Crohn’s Disease at Week 364","definition_or_measurement_approach":"Proportion (%) of participants achieving endoscopic remission by Simplified Endoscopic Score for Crohn's Disease at Week 364."}
  • {"endpoint_text":"- Percentage of participants with UC achieving clinical remission per Modified Mayo Score at Week 364","definition_or_measurement_approach":"Proportion (%) of participants with ulcerative colitis achieving clinical remission by Modified Mayo Score at Week 364."}

Recruitment

Planned Sample Size
913
Recruitment Window Months
128
Consent Approach
Informed consent obtained from participants. Subject information and informed consent forms are provided and available per country (documents listed for France, Hungary, Poland, Czechia). Separate/optional forms include genetic consent and an optional associated person form; no assent procedures for minors are indicated (adult participants).

Geography

Total Number Of Sites
22
Total Number Of Participants
137

France

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
480
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
CHRU De Nancy
Department Name
Hépato-Gastro-Entérologie
Contact Person Name
Marine Ferry
Contact Person Email
m.ferry@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hépato-Gastro-Entérologie
Contact Person Name
Adrien Nicolau
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Hépato-Gastro-Entérologie
Contact Person Name
Xavier Treton
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hépato-Gastro-Entérologie
Contact Person Name
Maria Nachury
Contact Person Email
maria.nachury@chru-lille.fr

Hungary

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
502
Number Of Sites
2
Number Of Participants
27

Sites

Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
4. Belgyógyászat - 2. Gasztroenterológia
Contact Person Name
Marta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
Semmelweis University
Department Name
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Contact Person Name
Pal Miheller

Poland

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
483
Number Of Sites
14
Number Of Participants
55

Sites

Site Name
Vita Longa Sp. z o.o.
Contact Person Name
Przemysław Ramos
Contact Person Email
biuro@researchsolutions.pl
Site Name
Futuremeds Sp. z o.o. (Cracow)
Department Name
Oncology
Contact Person Name
Piotr Rozpondek
Contact Person Email
piotr.rozpondek@futuremeds.com
Site Name
Medical Network Sp. z o.o.
Contact Person Name
Jarosław Kierkuś
Contact Person Email
wip@wip.waw.pl
Site Name
Centrum Medyczne Oporow
Contact Person Name
Radoslaw Kempinski
Contact Person Email
piotr.klepacki@cmoporow.com
Site Name
Eb Group Sp. z o.o.
Contact Person Name
Marek Woynarowski
Contact Person Email
bk@czmdm.pl
Site Name
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Contact Person Name
Robert Petryka
Contact Person Email
badania@vivamed.com.pl
Site Name
Rivermed Sp. z o.o.
Contact Person Name
Łukasz Hordecki
Contact Person Email
monika.jakubowska@rivermed.pl
Site Name
Sonomed Sp. z o.o.
Contact Person Name
Anna Wiechowska-Kozłowska
Contact Person Email
biuro@sonomedszczecin.pl
Site Name
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
Contact Person Name
Maciej Kowalski
Contact Person Email
j.kolecka@szpitalbarska.pl
Site Name
Bonifraterskie Centrum Medyczne Sp. z o.o.
Department Name
Pracownia Endoskopii
Contact Person Name
Wojciech Piotrowski
Contact Person Email
badania.jb@gmail.com
Site Name
1 Wojskowy Szpital Kliniczny Z Poliklinika ... W Lublinie
Department Name
Oddział Gastroenterologii
Contact Person Name
Przemysław Zając
Contact Person Email
marlena.krzyszczak@komed-ck.pl
Site Name
Medrise Sp. z o.o.
Contact Person Name
Wit Danilkiewicz
Contact Person Email
biuro@medrise.pl
Site Name
Futuremeds Sp. z o.o. (Wroclaw)
Contact Person Name
Szymon Wieczorek
Site Name
Melita Medical Sp. z o.o.
Contact Person Name
Jaroslaw Leszczyszyn

Czechia

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
478
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Hepato-Gastroenterologie HK s.r.o.
Department Name
Hepato-Gastroenterologie HK s.r.o.
Contact Person Name
Tomáš Vaňásek
Site Name
Vojenska Nemocnice Brno
Department Name
Vojenska Nemocnice Brno
Contact Person Name
David Štěpek
Contact Person Email
dstepek@vnbrno.cz

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Clinique Inc.
Responsibilities
sponsorDuties code: 4
Name
PPD Global Central Labs
Responsibilities
sponsorDuties code: 4
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting); Report EUB Call center
Name
Almac Diagnostic Services Limited
Responsibilities
sponsorDuties code: 4
Name
Signant Health LLC
Responsibilities
sponsorDuties code: 3

Third parties

  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting); Report EUB Call center","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
tulisokibart
Active Substance
TULISOKIBART
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Investigational Product Name
Placebo to MK-7240 (Tulisokibart)
Modality
Other

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