Clinical trial NCT06651281: Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Official title: A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn Disease
Colitis, Ulcerative
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 1380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This extension study will enroll participants who choose to enter from certain studies in which they are already receiving treatment (their "parent studies"). They will enter the appropriate arm in this study that will provide the same treatment they had been receiving on their parent study.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Has prematurely discontinued study intervention in their parent study
* Has received any protocol-specified prohibited medications during their parent study
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 378 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 364 weeks
Secondary outcomes:
measure: Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
timeFrame: Week 364
measure: Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
timeFrame: Week 364
measure: Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: Week 364
measure: Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)
timeFrame: Week 364
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute ( Site 0297)
state: Connecticut
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
state: Michigan
city: Liberty
country: United States
facility: BVL Research - Kansas ( Site 0292)
state: Missouri
city: Garland
country: United States
facility: GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
state: Texas
city: Lubbock
country: United States
facility: GI Alliance - Lubbock ( Site 0288)
state: Texas
city: Lubbock
country: United States
facility: Caprock Gastro Research ( Site 0293)
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute ( Site 0299)
state: Texas
city: Southlake
country: United States
facility: GI Alliance - Southlake ( Site 0298)
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute ( Site 0294)
state: Texas
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma ( Site 0295)
state: Washington
city: Wroclaw
country: Poland
facility: Przychodnia Futuremeds Wroclaw ( Site 2211)
state: Dolnoslaskie
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Bonifraterskie Centrum Medyczne ( Site 2207)
state: Lodzkie
city: Lublin
country: Poland
facility: Medrise Sp. z o.o. ( Site 2200)
state: Lubelskie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne ( Site 2210)
state: Malopolskie
city: Warsawa
country: Poland
facility: Vivamed Sp. z o.o. ( Site 2201)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM ( Site 2202)
state: Mazowieckie
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
state: Mazowieckie
city: Katowice
country: Poland
facility: Vita Longa Sp. Zoo ( Site 2213)
state: Slaskie
city: Poznan
country: Poland
facility: Rivermed Sp. z.o.o. ( Site 2206)
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Sonomed Sp. z o. o. ( Site 2203)
state: Zachodniopomorskie
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: