Colitis, Ulcerative · Crohn Disease
Long-term tulisokibart extension study for Crohn’s disease or ulcerative colitis
This Phase 3 extension study is examining the long-term safety, tolerability, and efficacy of subcutaneous tulisokibart in people with Crohn’s disease or ulcerative colitis continuing from certain tulisokibart parent studies.
Registry title: Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
12 recruiting U.S. sites ↓Study at a glance
- Age
- Not provided
- Treatment
- Tulisokibart or Placebo to tulisokibart
- Design
- Non Randomized · Quadruple
- Central study contact
- Toll Free Number1-888-577-8839Trialsites@msd.com
- Sponsor
- Merck Sharp & Dohme LLC
Research question
What are the long-term safety, tolerability, and efficacy outcomes of continuing tulisokibart in participants with Crohn’s disease or ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for people with Crohn’s disease or ulcerative colitis.
- Participants must have taken part in a qualifying Phase 2 or Phase 3 tulisokibart parent study.
- The parent-study investigator must determine that continued study treatment provides clinical benefit based on evaluations performed during the parent study.
- The registry accepts all sexes and lists child, adult, and older-adult age categories, but does not report exact age limits.
Participation overview
What participation may involve
Participants continue into the extension group corresponding to their parent-study treatment. The study follows adverse events and treatment discontinuations and evaluates longer-term Crohn’s disease or ulcerative colitis outcomes. What participation may involve: - Receive low- or high-dose tulisokibart, or possibly matching placebo in the blinded low-dose group, by subcutaneous injection. - Be monitored for adverse events and whether an adverse event leads to stopping study treatment. - Have disease outcomes assessed using measures applicable to Crohn’s disease or ulcerative colitis, including symptoms and endoscopic findings.
Study interventions
What participants may receive or do
- Tulisokibart: Tulisokibart, also called MK-7240, is a humanized monoclonal antibody that binds tumor necrosis factor-like cytokine 1A (TL1A). It is given by subcutaneous injection in low- or high-dose regimens.
- Placebo to tulisokibart: This is a placebo designed to match subcutaneous tulisokibart. The registry associates it only with Group 4, the blinded low-dose group.
Study design
How the comparison works
This is a non-randomized, parallel-group Phase 3 extension study. Participants enter from certain parent studies and continue the treatment assigned there in the corresponding extension-study group. Participants are not newly randomized in this extension study; their group follows the treatment they were receiving in the parent study. Groups 1 and 2 remain unblinded. Groups 3 and 4 remain blinded from their parent studies, with the participant, care provider, investigator, and outcomes assessor listed as masked. The registry lists a matching placebo only in Group 4, the blinded low-dose group; the other groups list tulisokibart alone. A matching subcutaneous placebo is listed for Group 4, but the record does not state the chance that a participant in that group receives placebo.
Reported activities
Procedures and tests
- Subcutaneous administration of tulisokibart or matching placebo.
- Monitoring and recording of adverse events, including adverse events that result in stopping study treatment.
- For participants with Crohn’s disease, assessment using the Crohn’s Disease Activity Index (CDAI).
- For participants with Crohn’s disease, tracking average daily stool frequency and abdominal pain scores.
- For participants with Crohn’s disease, evaluation of ileocolonoscopic findings using the Simplified Endoscopic Score for Crohn’s Disease, scored by a central reader.
- For participants with ulcerative colitis, assessment using the Modified Mayo Score, including endoscopic findings, stool frequency, and rectal bleeding.
- For participants of childbearing potential, a highly sensitive urine or serum pregnancy test is required before the first extension-study dose.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have taken part in a qualifying tulisokibart Phase 2 or Phase 3 parent study for Crohn’s disease or ulcerative colitis.
- The investigator must determine from clinical evaluations in the parent study that the participant derives clinical benefit from continuing the study intervention.
- A participant assigned female sex at birth must not breastfeed during treatment or for at least 14 weeks after the final dose.
- A participant of childbearing potential must not be pregnant and must have a negative highly sensitive pregnancy test within 24 hours for urine or 72 hours for serum before the first dose, as required locally.
- A participant of childbearing potential must use an acceptable contraceptive method or maintain long-term, persistent abstinence from penile-vaginal intercourse as their usual lifestyle.
Possible reasons someone may not be able to join
- People who stopped the study intervention early in their parent study are excluded.
- People who received a medication prohibited by the parent-study protocol are excluded.
- People with a known allergy, hypersensitivity, or intolerance to tulisokibart or any of its inactive ingredients are excluded.
Important unknowns
What the record does not make clear
- The registry does not state how often participants attend study visits or which visits may occur remotely.
- Outcome timeframes extend to approximately 364 or 378 weeks, but the registry does not explicitly state each participant’s total participation duration.
- A matching placebo is listed for Group 4, but the record does not report the chance of receiving placebo.
- The record says participants continue their parent-study treatment but does not explain which nonstudy Crohn’s disease or ulcerative colitis treatments may continue.
- The eligibility criteria refer to protocol-specified prohibited medications but do not identify them or describe any washout periods.
- The registry does not describe rescue treatment if Crohn’s disease or ulcerative colitis worsens.
- Endoscopic outcomes are reported for Crohn’s disease and ulcerative colitis, but the record does not clearly state the required endoscopy schedule for participants.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether travel, lodging, parking, or meal support is available.
- The registry does not state whether tulisokibart will remain available after a participant completes or leaves the extension study.
Before contacting the site
Questions for the study team
- Which parent studies and treatment assignments can transition into this extension study?
- What is the full visit schedule, and which visits or assessments must be completed in person?
- How long would I receive study treatment, and how long would follow-up continue?
- If I enter the blinded low-dose group, what is the chance of receiving placebo, and when would my treatment assignment be revealed?
- Which endoscopies, symptom records, blood tests, or other assessments are required, and at what times?
- Which current medicines can continue, which are prohibited, and are any washout periods required?
- What happens if my disease worsens, I have an adverse event, or I need to stop study treatment?
- Which costs are covered, and are compensation or travel support available?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease or ulcerative colitis now, and what signs would suggest that continuing in an extension study needs reconsideration?
- Would any of my current medicines need to change, and what risks could interruption or washout create in my clinical situation?
- What approved treatment alternatives should I understand before considering continued study treatment?
- How should you and the research team coordinate disease monitoring, endoscopy results, adverse events, and treatment decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Merck Sharp & Dohme LLC
- Organization class
- Industry
- Organization study ID
- 7240-011
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Group 1: Low Dose Unblinded
Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
Interventions: Drug: Tulisokibart
Experimental
Group 2: High Dose Unblinded
Participants receive a high dose SC tulisokibart regimen.
Interventions: Drug: Tulisokibart
Experimental
Group 3: High Dose Blinded
Participants receive a blinded high dose SC tulisokibart regimen.
Interventions: Drug: Tulisokibart
Experimental
Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen.
Interventions: Drug: Tulisokibart, Drug: Placebo to tulisokibart
Interventions
Drug
Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Drug
Placebo to tulisokibart
Placebo matching SC tulisokibart
Eligibility
Not provided
All
Not accepted
Inclusion criteria (5)
- Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UCRegistry-derived · unreviewed
- The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent studyRegistry-derived · unreviewed
- 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 interventionRegistry-derived · unreviewed
- 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 interventionRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
Exclusion criteria (3)
- Has prematurely discontinued study intervention in their parent studyRegistry-derived · unreviewed
- Has received any protocol-specified prohibited medications during their parent studyRegistry-derived · unreviewed
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipientsRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: 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.
Primary outcome
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: 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
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Time frame: 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.
Secondary outcome
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
Time frame: 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.
Secondary outcome
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: 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.
Secondary outcome
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)
Time frame: 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.
Recruiting locations in the United States
Connecticut Clinical Research Institute ( Site 0297)
RecruitingBristol, Connecticut, 06010, United States
Study Coordinator860-585-3000
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
RecruitingYpsilanti, Michigan, 48197, United States
Study Coordinator734-418-7736
BVL Research - Kansas ( Site 0292)
RecruitingLiberty, Missouri, 64068, United States
Study Coordinator785-217-6559
New York Gastroenterology Associates ( Site 0253)
RecruitingNew York, New York, 10075, United States
Study Coordinator212-369-2490
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
RecruitingGarland, Texas, 75044, United States
Study Coordinator972-265-8201
Caprock Gastro Research ( Site 0293)
RecruitingLubbock, Texas, 79424, United States
Study Coordinator808-239-1823
GI Alliance - Lubbock ( Site 0288)
RecruitingLubbock, Texas, 79410, United States
Study Coordinator806-793-3141
Southern Star Research Institute ( Site 0299)
RecruitingSan Antonio, Texas, 78229, United States
Study Coordinator210-581-2812
GI Alliance - Southlake ( Site 0298)
RecruitingSouthlake, Texas, 76092-9167, United States
Study Coordinator817-424-1525
Tyler Research Institute ( Site 0294)
RecruitingTyler, Texas, 75701, United States
Study Coordinator903-630-6211
University of Virginia Health System ( Site 0291)
RecruitingCharlottesville, Virginia, 22908, United States
Study Coordinator434-243-3090
Washington Gastroenterology - Tacoma ( Site 0295)
RecruitingTacoma, Washington, 98405, United States
Study Coordinator425-452-8547
This study also lists 25 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 21, 2024
- Primary completion
- Dec 17, 2037
- Overall completion
- Dec 17, 2037
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.