RecruitingNCT06651281ClinicalTrials.gov record

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Crohn Disease · Colitis, Ulcerative

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: Not specified - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 1380 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Has participated in a qualifying tulisokibart 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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not randomized
Masking: Quadruple masked

Group 1: Low Dose Unblinded

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

Drug: Tulisokibart

Group 2: High Dose Unblinded

Participants receive a high dose SC tulisokibart regimen.

Drug: Tulisokibart

Group 3: High Dose Blinded

Participants receive a blinded high dose SC tulisokibart regimen.

Drug: Tulisokibart

Group 4: Low Dose Blinded

Participants receive a blinded low dose SC tulisokibart regimen.

Drug: Tulisokibart · Drug: Placebo to tulisokibart

Tulisokibart DRUG

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

Placebo to tulisokibart DRUG

Placebo matching SC tulisokibart

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 364 weeks

Other measures

Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score

Time frame: Up to 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

Time frame: Up to 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)

Time frame: Up to 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)

Time frame: Up to 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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (37)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

37 locations

Connecticut Clinical Research Institute ( Site 0297)Bristol, Connecticut, United StatesRecruiting

Study CoordinatorCONTACT860-585-3000

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Other measures

Research locations (37)

Study team and timeline

Official study contacts

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