A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

StatusRecruiting

PhasePhase 3

SponsorMerck Sharp & Dohme LLC

Started2024-06-05

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoint reworded 4 of 9 changed

See other at-risk trials from Merck (MSD)

Amendment history

The 50 most recent of 94 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-11

Study Status, Contacts/Locations v93

Study sites499 entries, revised

~~KLINICKE CENTRUM~~ Pratia ~~Brno, Pratia Brno~~Czech s.r.o. ( Site 0657)

2026-09-05

Study Status, Contacts/Locations v92

Study sitesdetails revised at 2 of 499 sites

2026-08-20

Study Status, Contacts/Locations v91

Study sites499 entries, revised

Morales Vargas Centro de Investigacion S. C. ( Site 3101)

2026-08-04

Study Status, Outcome Measures, Eligibility, Contacts/Locations v90

Primary endpoint(s) modified9 entries, revised

WasStudy 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52, Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52, Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12, Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52, Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

NowStudy 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52, Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52, Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12, Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52, Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

Eligibility criteria+51 characters

[...] o the following: Inclusion Criteria: Has had a diagnosis of Crohn's disease (CD) at least 3 months before study. Has moderately to severely [...] yndrome, or any other uncontrolled chronic diarrhea besides ~~Crohn's disease~~CD. Has surgical bowel resection within 3 months of study. Has [...] exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Secondary endpoints31 to 32 entries

Study 1: ~~Percentage~~Number of Participants Who Experienced an Adverse Event (AE) Study 1: ~~Percentage~~Number of Participants ~~who~~Who Discontinue Study Intervention due to an AE Study 1: Percentage of Participants ~~with~~With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) ~~in CDAI Score from Baseline to~~at Week 12 Study 1: Mean Change ~~from~~From Baseline in Functional Assessment of Chronic Illness Therap [...] e (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12 Study 1 and 2: Percentage of Participants in ~~Diagnostic Assay Positive (~~Dx+) Subpopulation Achieving E [...] [...]

Study sitesdetails revised at 1 of 499 sites

2026-07-10

Study Status, Contacts/Locations v89

Study sitesdetails revised at 2 of 499 sites

Show 45 earlier versions

2026-06-25

Study Status, Contacts/Locations v88

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2026-06-17

Study Status, Contacts/Locations v87

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2026-06-11

Study Status, Contacts/Locations v86

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2026-06-05

Study Status, Contacts/Locations v85

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2026-05-28

Study Status, Contacts/Locations v84

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2026-05-15

Study Status, Contacts/Locations v83

Study sites499 entries, revised

Melita Medical Sp. z o.o. ( Site 1607) EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1618)

2026-05-08

Study Status, Contacts/Locations v82

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2026-04-30

Study Status, Contacts/Locations v81

Study sitesdetails revised at 1 of 499 sites

2026-04-22

Study Status, Contacts/Locations v80

Study sites499 entries, revised

~~Toronto~~TDDA ~~Digestive Disease Associates~~Inc. ( Site 0006)

2026-04-16

Study Status, Contacts/Locations v79

Study sites499 entries, revised

Wits Clinical Research-~~Wits~~Chris ~~Clinical~~Hani ~~Research~~Baragwanath ~~Bara~~Hospital ( Site 4005)

2026-04-08

Study Status, Contacts/Locations v78

Study sites499 entries, revised

Iwate Medical University ~~Uchimaru Medical Center~~Hospital ( Site 3457)

2026-04-02

Study Status, Contacts/Locations v77

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2026-03-27

Study Status, Contacts/Locations v76

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2026-03-18

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2026-03-11

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2026-03-04

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2026-02-26

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2026-02-20

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2026-02-10

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2026-02-03

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2026-01-29

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2026-01-23

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2026-01-16

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2026-01-08

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2026-01-02

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2025-12-23

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2025-12-18

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2025-12-12

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2025-12-04

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Amicis Research Center ~~- Valencia~~ ( Site 5055) ~~SIX08~~Prairie ~~Gastroenterology~~Institute of Liver and Luminal Advanced Research ( Site 0015) Pratia ~~Poznań~~S.A. Pratia Poznan ( Site 1603)

2025-11-27

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2025-11-12

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2025-10-28

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2025-09-24

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2025-09-17

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2025-08-27

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2025-08-13

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2025-07-30

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2025-07-24

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2025-07-16

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Merck (MSD)

401 trials monitored

See 24 trials at risk

Crohn's Disease

608 trials monitored

See 27 trials at risk

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Trial Details

NCT Number	NCT06430801
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Crohn's Disease
Enrollment	1,200 participants
Start Date	2024-06-05
Primary Completion	2028-10-30 (estimated)
Study Completion	2029-11-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-29