Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
- Conditions
- Crohn DiseaseColitis, Ulcerative
- Interventions
- Drug: Placebo to tulisokibart
- Registration Number
- NCT06651281
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1380
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Low Dose Unblinded Tulisokibart Participants receive a low dose subcutaneous (SC) tulisokibart regimen. Group 2: High Dose Unblinded Tulisokibart Participants receive a high dose SC tulisokibart regimen. Group 3: High Dose Blinded Tulisokibart Participants receive a blinded high dose SC tulisokibart regimen. Group 4: Low Dose Blinded Tulisokibart Participants receive a blinded low dose SC tulisokibart regimen. Group 4: Low Dose Blinded Placebo to tulisokibart Participants receive a blinded low dose SC tulisokibart regimen.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 378 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 364 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score Week 364 The percentage of participants who enrolled in their parent study with Crohn's disease who achieve clinical remission, as defined by CDAI score \<150, at Week 364 will be presented.
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score Week 364 The percentage of participants who enrolled in their parent study with Crohn's disease achieving clinical remission at Week 364 per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline will be presented.
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD) Week 364 The Simplified Endoscopic Score for Crohn's Disease (SES-CD) measures ileocolonoscopic findings in Crohn's Disease. Each segment of the ileo-colon (terminal ileum; ascending, transverse, and descending colon; rectum) is scored from 0 (normal or inactive disease) to 12 (severe disease; no more than one segment can have a score of 12, in which case the other 4 segments must each be ≤11), and the scores summed to produce an SES-CD ranging from 0 (overall least severe disease) to 56 (overall most severe disease). Endoscopic remission is defined as an SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable, as scored by central reader.
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS) Week 364 The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Trial Locations
- Locations (21)
Przychodnia Futuremeds Wroclaw ( Site 2211)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
🇵🇱Wloclawek, Kujawsko-pomorskie, Poland
Bonifraterskie Centrum Medyczne ( Site 2207)
🇵🇱Lodz, Lodzkie, Poland
Krakowskie Centrum Medyczne ( Site 2210)
🇵🇱Krakow, Malopolskie, Poland
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
🇵🇱Warszawa, Mazowieckie, Poland
Rivermed Sp. z.o.o. ( Site 2206)
🇵🇱Poznan, Wielkopolskie, Poland
Connecticut Clinical Research Institute ( Site 0297)
🇺🇸Bristol, Connecticut, United States
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
🇺🇸Ypsilanti, Michigan, United States
BVL Research - Kansas ( Site 0292)
🇺🇸Liberty, Missouri, United States
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
🇺🇸Garland, Texas, United States
GI Alliance - Lubbock ( Site 0288)
🇺🇸Lubbock, Texas, United States
Caprock Gastro Research ( Site 0293)
🇺🇸Lubbock, Texas, United States
Southern Star Research Institute ( Site 0299)
🇺🇸San Antonio, Texas, United States
GI Alliance - Southlake ( Site 0298)
🇺🇸Southlake, Texas, United States
Tyler Research Institute ( Site 0294)
🇺🇸Tyler, Texas, United States
Washington Gastroenterology - Tacoma ( Site 0295)
🇺🇸Tacoma, Washington, United States
Medrise Sp. z o.o. ( Site 2200)
🇵🇱Lublin, Lubelskie, Poland
Vivamed Sp. z o.o. ( Site 2201)
🇵🇱Warsawa, Mazowieckie, Poland
Centrum Zdrowia MDM ( Site 2202)
🇵🇱Warszawa, Mazowieckie, Poland
Vita Longa Sp. Zoo ( Site 2213)
🇵🇱Katowice, Slaskie, Poland
Sonomed Sp. z o. o. ( Site 2203)
🇵🇱Szczecin, Zachodniopomorskie, Poland