Actively Recruiting
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Led by Merck Sharp & Dohme LLC · Updated on 2025-12-26
1380
Participants Needed
37
Research Sites
681 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
CONDITIONS
Official Title
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for Crohn's disease or ulcerative colitis
- Investigator determines participant benefits clinically from continued study intervention based on parent study evaluations
- Female participants assigned at birth are not breastfeeding during the study and for at least 14 weeks after last dose
- Participants of childbearing potential are not pregnant and have a negative sensitive pregnancy test within 24 hours (urine) or 72 hours (serum) before first dose
- Participants of childbearing potential use acceptable contraception or practice penile-vaginal abstinence as their usual lifestyle
You will not qualify if you...
- Premature discontinuation of study intervention in parent study
- Use of any protocol-specified prohibited medications during parent study
- Known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Connecticut Clinical Research Institute ( Site 0297)
Bristol, Connecticut, United States, 06010
Actively Recruiting
2
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
3
BVL Research - Kansas ( Site 0292)
Liberty, Missouri, United States, 64068
Actively Recruiting
4
New York Gastroenterology Associates ( Site 0253)
New York, New York, United States, 10075
Actively Recruiting
5
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
Garland, Texas, United States, 75044
Actively Recruiting
6
GI Alliance - Lubbock ( Site 0288)
Lubbock, Texas, United States, 79410
Actively Recruiting
7
Caprock Gastro Research ( Site 0293)
Lubbock, Texas, United States, 79424
Actively Recruiting
8
Southern Star Research Institute ( Site 0299)
San Antonio, Texas, United States, 78229
Actively Recruiting
9
GI Alliance - Southlake ( Site 0298)
Southlake, Texas, United States, 76092-9167
Actively Recruiting
10
Tyler Research Institute ( Site 0294)
Tyler, Texas, United States, 75701
Actively Recruiting
11
University of Virginia Health System ( Site 0291)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
12
Washington Gastroenterology - Tacoma ( Site 0295)
Tacoma, Washington, United States, 98405
Actively Recruiting
13
Vojenská Nemocnice Brno-Internal department ( Site 0701)
Brno, Brno-mesto, Czechia, 615 00
Actively Recruiting
14
Hepato-Gastroenterologie HK ( Site 0700)
Hradec Králové, Czechia, 50012
Actively Recruiting
15
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)
Nice, Alpes-Maritimes, France, 06202
Actively Recruiting
16
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)
Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
Actively Recruiting
17
CHRU De Nancy - Hopital de Brabois ( Site 1001)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
Actively Recruiting
18
Hopital Claude Huriez CHRU LILLE ( Site 1004)
Lille, Nord, France, 59037
Actively Recruiting
19
ARENSIA Exploratory Medicine Georgia ( Site 1104)
Tbilisi, Georgia, 0112
Actively Recruiting
20
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)
Békéscsaba, Bekes County, Hungary, 5600
Actively Recruiting
21
Semmelweis Egyetem ( Site 1400)
Budapest, Hungary, 1082
Actively Recruiting
22
Rivermed Sp. z.o.o. ( Site 2206)
Poznan, Greater Poland Voivodeship, Poland, 61-441
Actively Recruiting
23
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800
Actively Recruiting
24
Krakowskie Centrum Medyczne ( Site 2210)
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
25
Centrum Medyczne Oporow ( Site 2212)
Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
Actively Recruiting
26
Melita Medical ( Site 2204)
Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
Actively Recruiting
27
Przychodnia Futuremeds Wroclaw ( Site 2211)
Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
Actively Recruiting
28
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)
Lublin, Lublin Voivodeship, Poland, 20-059
Actively Recruiting
29
Medrise Sp. z o.o. ( Site 2200)
Lublin, Lublin Voivodeship, Poland, 20-582
Actively Recruiting
30
Centrum Zdrowia MDM ( Site 2202)
Warsaw, Masovian Voivodeship, Poland, 00-189
Actively Recruiting
31
Vivamed Sp. z o.o. ( Site 2201)
Warsaw, Masovian Voivodeship, Poland, 03-580
Actively Recruiting
32
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
Warsaw, Masovian Voivodeship, Poland, 04-501
Actively Recruiting
33
Vita Longa Sp. Zoo ( Site 2213)
Katowice, Silesian Voivodeship, Poland, 40-748
Actively Recruiting
34
Sonomed Sp. z o. o. ( Site 2203)
Szczecin, West Pomeranian Voivodeship, Poland, 71-685
Actively Recruiting
35
Bonifraterskie Centrum Medyczne ( Site 2207)
Lodz, Łódź Voivodeship, Poland, 93-357
Actively Recruiting
36
Whipps Cross University Hospital ( Site 3400)
London, England, United Kingdom, E11 1NR
Active, Not Recruiting
37
MAC Research - Merseyside ( Site 3401)
Prescot, Knowsley, United Kingdom, L34 1BH
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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