A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
• The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
• A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
• A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
• A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)
Locations
United States
Connecticut
Connecticut Clinical Research Institute ( Site 0297)
RECRUITING
Bristol
Michigan
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
RECRUITING
Ypsilanti
Missouri
BVL Research - Kansas ( Site 0292)
RECRUITING
Liberty
New York
New York Gastroenterology Associates ( Site 0253)
RECRUITING
New York
Texas
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
RECRUITING
Garland
Caprock Gastro Research ( Site 0293)
RECRUITING
Lubbock
GI Alliance - Lubbock ( Site 0288)
RECRUITING
Lubbock
Southern Star Research Institute ( Site 0299)
RECRUITING
San Antonio
GI Alliance - Southlake ( Site 0298)
RECRUITING
Southlake
Tyler Research Institute ( Site 0294)
RECRUITING
Tyler
Virginia
University of Virginia Health System ( Site 0291)
RECRUITING
Charlottesville
Washington
Washington Gastroenterology - Tacoma ( Site 0295)
RECRUITING
Tacoma
Other Locations
France
Hopital Claude Huriez CHRU LILLE ( Site 1004)
RECRUITING
Lille
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)
RECRUITING
Neuilly-sur-seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)
RECRUITING
Nice
CHRU De Nancy - Hopital de Brabois ( Site 1001)
RECRUITING
Vandœuvre-lès-nancy
Georgia
ARENSIA Exploratory Medicine Georgia ( Site 1104)
RECRUITING
Tbilisi
Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)
RECRUITING
Békéscsaba
Semmelweis Egyetem ( Site 1400)
RECRUITING
Budapest
Poland
Vita Longa Sp. Zoo ( Site 2213)
RECRUITING
Katowice
Krakowskie Centrum Medyczne ( Site 2210)
RECRUITING
Krakow
Bonifraterskie Centrum Medyczne ( Site 2207)
RECRUITING
Lodz
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)
RECRUITING
Lublin
Medrise Sp. z o.o. ( Site 2200)
RECRUITING
Lublin
Rivermed Sp. z.o.o. ( Site 2206)
RECRUITING
Poznan
Sonomed Sp. z o. o. ( Site 2203)
RECRUITING
Szczecin
Centrum Zdrowia MDM ( Site 2202)
RECRUITING
Warsaw
Vivamed Sp. z o.o. ( Site 2201)
RECRUITING
Warsaw
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
RECRUITING
Warsaw
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
RECRUITING
Włocławek
Centrum Medyczne Oporow ( Site 2212)
RECRUITING
Wroclaw
Melita Medical ( Site 2204)
RECRUITING
Wroclaw
Przychodnia Futuremeds Wroclaw ( Site 2211)
RECRUITING
Wroclaw
United Kingdom
Whipps Cross University Hospital ( Site 3400)
RECRUITING
London
MAC Research - Merseyside ( Site 3401)
RECRUITING
Prescot
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2024-11-25
Estimated Completion Date:2037-12-17
Participants
Target number of participants:1380
Treatments
Experimental: Group 1: Low Dose Unblinded
Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
Experimental: Group 2: High Dose Unblinded
Participants receive a high dose SC tulisokibart regimen.
Experimental: Group 3: High Dose Blinded
Participants receive a blinded high dose SC tulisokibart regimen.
Experimental: Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen.