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RecruitingNCT06430801Updated Nov 10, 2026

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

A Phase 3 interventional study of IV Tulisokibart and SC Tulisokibart in Crohn's Disease, sponsored by Merck Sharp & Dohme LLC. Recruiting at 499 sites in 47 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Updated Nov 10, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
All
01

Study summary

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).

Read the detailed description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

02

Conditions studied

  • Crohn's Disease

Browse trials for

03

In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion criteria

Inclusion Criteria:

  • Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
  • Has moderately to severely active CD.
  • Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting , systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
  • Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion criteria

Exclusion Criteria:

  • Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  • Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
  • Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Has current stoma or need for colostomy or ileostomy.
  • Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
  • Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
  • Has surgical bowel resection within 3 months of study.
  • Has prior or current gastrointestinal dysplasia.
  • Has chronic infection requiring ongoing antimicrobial treatment.
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
  • Is infected with virus (HBV), virus (HCV), or (HIV).
  • Has active tuberculosis.
  • Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
  • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Study 1: High Dose Induction, High Dose Maintenance

    Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.

    Drug: IV Tulisokibart · Drug: SC Tulisokibart

  • Experimental
    Study 1: High Dose Induction, Low Dose Maintenance

    Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

    Drug: IV Tulisokibart · Drug: SC Tulisokibart · Other: SC Placebo

  • Experimental
    Study 1: Low Dose Induction, Low Dose Maintenance

    Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

    Drug: IV Tulisokibart · Drug: SC Tulisokibart · Other: SC Placebo

  • Placebo comparator
    Study 1: Placebo

    Participants receive IV placebo, followed by an SC placebo regimen.

    Drug: IV Tulisokibart · Other: IV Placebo · Other: SC Placebo

  • Experimental
    Study 1: High Dose Extension

    Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

    Drug: SC Tulisokibart

  • Experimental
    Study 1: Low Dose Extension

    Participants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

    Drug: SC Tulisokibart · Other: SC Placebo

  • Experimental
    Study 2: High Dose Induction

    Participants receive high dose IV tulisokibart.

    Drug: IV Tulisokibart

  • Experimental
    Study 2: Low Dose Induction

    Participants receive low dose IV tulisokibart.

    Drug: IV Tulisokibart · Other: SC Placebo

  • Placebo comparator
    Study 2: Placebo

    Participants receive IV placebo.

    Drug: IV Tulisokibart · Other: IV Placebo · Other: SC Placebo

  • Experimental
    Study 2: High Dose Extension

    Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

    Drug: SC Tulisokibart

  • Experimental
    Study 2: Low Dose Extension

    Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

    Drug: SC Tulisokibart

Interventions

  • DrugIV Tulisokibart

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

    Also known as: PRA023, MK-7240

  • DrugSC Tulisokibart

    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

    Also known as: PRA023, MK-7240

  • OtherIV Placebo

    Placebo matching IV tulisokibart

  • OtherSC Placebo

    Placebo matching SC tulisokibart

06

What researchers measure

Primary outcomes

  1. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

    Time frame: Week 52

  2. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants achieving clinical remission 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 for Study 1 will be presented.

    Time frame: Week 52

  3. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for Study 1 will be presented.

    Time frame: Week 52

  4. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

    Time frame: Week 12

  5. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Time frame: Week 12

  6. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 1 will be presented.

    Time frame: Week 12

  7. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.

    Time frame: Week 12

  8. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

    Time frame: Week 12

  9. Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 2 will be presented.

    Time frame: Week 12

Secondary outcomes

  1. Study 1: Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 1 will be presented.

    Time frame: Up to approximately 52 weeks

  2. Study 1: Number of Participants Who Discontinue Study Intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 1 will be presented.

    Time frame: Up to approximately 52 weeks

  3. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Time frame: Week 12

  4. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

    Time frame: Week 12

  5. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) at Week 12

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

    Time frame: Week 12

  6. Study 1: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

    Time frame: Baseline and Week 12

  7. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Time frame: Week 12

  8. Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 and Study 2 will be presented.

    Time frame: Week 12

  9. Study 1 and 2: Percentage of Participants in Dx+ Subpopulation Achieving Endoscopic Response at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a ≥50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for Study 1 and Study 2 will be presented.

    Time frame: Week 12

  10. Study 1: Percentage of Participants With Clinical Response (Decrease From Baseline at Least 100 Points) or Clinical Remission (<150) per CDAI Score at Week 6

    The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI \<150) for Study 1 will be presented.

    Time frame: Week 6

  11. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Time frame: Week 52

  12. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

    Time frame: Week 52

  13. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 52

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

    Time frame: Week 52

  14. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Time frame: Week 52

  15. Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52

    The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

    Time frame: Week 12 and Week 52

  16. Study 1 [US/FDA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52

    The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

    Time frame: Week 52

  17. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

    Time frame: Week 52

  18. Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.

    Time frame: Week 52

  19. Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score and Endoscopic Remission at Week 52

    The percentage of participants achieving clinical remission as defined by CDAI score \<150, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.

    Time frame: Week 52

  20. Study 1: Mean Change From Baseline in FACIT-Fatigue Score at Week 52

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

    Time frame: Baseline and Week 52

  21. Study 1 [EU/EMA Only]: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52

    The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 1 will be presented.

    Time frame: Baseline and Week 52

  22. Study 1: Percentage of Participants With Ulcer-Free Endoscopy at Week 52

    The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 1 will be presented.

    Time frame: Week 52

  23. Study 2: Number of Participants Who Experienced an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 2 will be presented.

    Time frame: Up to approximately 12 weeks

  24. Study 2: Number of Participants Who Discontinue Study Intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 2 will be presented.

    Time frame: Up to approximately 12 weeks

  25. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

    Time frame: Week 12

  26. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.

    Time frame: Week 12

  27. Study 2: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 12

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 2 will be presented.

    Time frame: Week 12

  28. Study 2: Mean Change From Baseline in FACIT-Fatigue Score at Week 12

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 2 will be presented.

    Time frame: Baseline and Week 12

  29. Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Time frame: Week 12

  30. Study 2 [EU/EMA Only]: Mean Change From Baseline in IBDQ Score at Week 12

    The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 2 will be presented.

    Time frame: Baseline and Week 12

  31. Study 2: Percentage of Participants With Clinical Response (Decreased From Baseline of ≥100 Points) or Clinical Remission (<150) per CDAI Score at Week 6

    The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI \<150) for Study 2 will be presented.

    Time frame: Week 6

  32. Study 2: Percentage of Participants With Ulcer-Free Endoscopy at Week 12

    The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 2 will be presented.

    Time frame: Week 12

07

Study locations

439 of 499 sites recruiting
  • Digestive Health Specialists ( Site 5064)
    Dothan, Alabama 36301, United States
    Completed

    Not enrolling at this site — choose another above.

  • Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
    Phoenix, Arizona 85032, United States
    Completed

    Not enrolling at this site — choose another above.

  • GI Alliance - Sun City ( Site 5118)
    Sun City, Arizona 85351, United States
    Recruiting
    • Study Coordinator · Contact623-972-2116
  • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
    Tucson, Arizona 85724, United States
    Recruiting
    • Study Coordinator · Contact520-626-8000
  • University of Arkansas for Medical Sciences ( Site 5147)
    Little Rock, Arkansas 72205, United States
    Recruiting
    • Study Coordinator · Contact501-398-8622
  • Clinnova Research ( Site 5110)
    Anaheim, California 92805, United States
    Recruiting
    • Study Coordinator · Contact949-889-0249
  • Southern California Research Center ( Site 5044)
    Coronado, California 92118, United States
    Recruiting
    • Study Coordinator · Contact619-522-0330
  • Om Research LLC ( Site 5038)
    Lancaster, California 93534, United States
    Recruiting
    • Study Coordinator · Contact661-388-2239
  • Cedars Sinai Medical Center ( Site 5080)
    Los Angeles, California 90048, United States
    Recruiting
    • Study Coordinator · Contact310-423-0035
  • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
    Los Angeles, California 90095, United States
    Recruiting
    • Study Coordinator · Contact310-206-3778
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
    Orange, California 92868, United States
    Recruiting
    • Study Coordinator · Contact714-456-7890
  • Om Research LLC ( Site 5045)
    Oxnard, California 93030, United States
    Recruiting
    • Study Coordinator · Contact661-388-2239
  • Clinical Applications Laboratories ( Site 5123)
    San Diego, California 92103, United States
    Recruiting
    • Study Coordinator · Contact619-260-1012
  • Amicis Research Center ( Site 5055)
    Valencia, California 91355, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
    Aurora, Colorado 80045, United States
    Recruiting
    • Study Coordinator · Contact720-848-2777
  • Peak Gastroenterology Associates ( Site 5023)
    Colorado Springs, Colorado 80907, United States
    Recruiting
    • Study Coordinator · Contact719-310-6719
  • South Denver Gastroenterology, PC ( Site 5132)
    Englewood, Colorado 80113, United States
    Recruiting
    • Study Coordinator · Contact303-406-4288
  • Rocky Mountain Gastroenterology ( Site 5082)
    Lakewood, Colorado 80228, United States
    Recruiting
    • Study Coordinator · Contact303-463-3900
  • Medical Research Center of Connecticut ( Site 5005)
    Hamden, Connecticut 06518, United States
    Completed

    Not enrolling at this site — choose another above.

  • Yale University School of Medicine-Digestive Disease ( Site 5019)
    New Haven, Connecticut 06510, United States
    Recruiting
    • Study Coordinator · Contact203-785-4138
  • Emerson Clinical Research Institute ( Site 5051)
    Washington D.C., District of Columbia 20009, United States
    Recruiting
    • Study Coordinator · Contact202-239-0777
  • Gastroenterology Consultants of Clearwater ( Site 5052)
    Clearwater, Florida 33756, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Covenant Metabolic Specialists, LLC ( Site 5150)
    Fort Myers, Florida 33912, United States
    Recruiting
    • Study Coordinator · Contact941-500-3200
  • Nature Coast Clinical Research - Inverness ( Site 5042)
    Inverness, Florida 34452, United States
    Recruiting
    • Study Coordinator · Contact352-341-2100
  • Atlantic Medical Research ( Site 5073)
    Margate, Florida 33063, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sanchez Clinical Research ( Site 5144)
    Miami, Florida 33157, United States
    Recruiting
    • Study Coordinator · Contact305-590-8555
  • AdventHealth Orlando ( Site 5131)
    Orlando, Florida 32803, United States
    Recruiting
    • Study Coordinator · Contact407-303-5503
  • Endoscopic Research Inc ( Site 5061)
    Orlando, Florida 32803, United States
    Recruiting
    • Study Coordinator · Contact407-896-1726 ext 314
  • Orlando Health-Digestive Health Institute ( Site 5010)
    Orlando, Florida 32806, United States
    Completed

    Not enrolling at this site — choose another above.

  • USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
    Tampa, Florida 33612, United States
    Recruiting
    • Study Coordinator · Contact813-396-2254
  • Covenant Metabolic Specialists, LLC ( Site 5143)
    University Park, Florida 34201, United States
    Recruiting
    • Study Coordinator · Contact941-500-3200
  • Morehouse School Of Medicine ( Site 5071)
    Atlanta, Georgia 30310, United States
    Recruiting
    • Study Coordinator · Contact404-616-1000
  • Atlanta Center for Gastroenterology ( Site 5035)
    Decatur, Georgia 30033, United States
    Completed

    Not enrolling at this site — choose another above.

  • Gastroenterology Associates of Central Georgia ( Site 5048)
    Macon, Georgia 31201, United States
    Recruiting
    • Study Coordinator · Contact478-464-2600
  • Eagle Clinical Research ( Site 5089)
    Chicago, Illinois 60621, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Chicago Medical Center ( Site 5066)
    Chicago, Illinois 60637, United States
    Recruiting
    • Study Coordinator · Contact773-834-2193
  • Endeavor Health ( Site 5018)
    Evanston, Illinois 60201, United States
    Recruiting
    • Study Coordinator · Contact847-971-9992
  • GI ALLIANCE - GURNEE ( Site 5003)
    Gurnee, Illinois 60031, United States
    Recruiting
    • Study Coordinator · Contact224-441-2217
  • Indiana University Health University Hospital ( Site 5022)
    Indianapolis, Indiana 46202, United States
    Recruiting
    • Study Coordinator · Contact317-944-3332
  • Iowa Digestive Disease Center ( Site 5007)
    Clive, Iowa 50325, United States
    Recruiting
    • Study Coordinator · Contact515-225-6050
  • University of Kansas Medical Center ( Site 5091)
    Kansas City, Kansas 66160, United States
    Recruiting
    • Study Coordinator · Contact913-588-6158
  • Cotton O'Neil Digestive Health Center ( Site 5033)
    Topeka, Kansas 66606, United States
    Recruiting
    • Study Coordinator · Contact785-270-4386
  • University of Louisville Hospital ( Site 5120)
    Louisville, Kentucky 40202, United States
    Recruiting
    • Study Coordinator · Contact502-852-1958
  • Southern Clinical Research ( Site 5095)
    Zachary, Louisiana 70791, United States
    Completed

    Not enrolling at this site — choose another above.

  • Walter Reed National Military Medical Center ( Site 5006)
    Bethesda, Maryland 20889, United States
    Recruiting
    • Study Coordinator · Contact301-295-6814
  • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
    Boston, Massachusetts 02114, United States
    Recruiting
    • Study Coordinator · Contact334-836-3341
  • University of Michigan ( Site 5060)
    Ann Arbor, Michigan 48109, United States
    Recruiting
    • Study Coordinator · Contact734-615-4843
  • Clinical Research Institute of Michigan, LLC ( Site 5002)
    Clinton Township, Michigan 48038, United States
    Recruiting
    • Study Coordinator · Contact586-598-3329
  • Mayo Clinic in Rochester, Minnesota ( Site 5024)
    Rochester, Minnesota 55905, United States
    Recruiting
    • Study Coordinator · Contact507-284-2511
  • Mid-America GI Clinical Research ( Site 5130)
    Kansas City, Missouri 64111, United States
    Recruiting
    • Study Coordinator · Contact816-561-2000
  • BVL Research - Kansas ( Site 5099)
    Liberty, Missouri 64068, United States
    Recruiting
    • Study Coordinator · Contact816-222-4241
  • Washington University School of Medicine ( Site 5058)
    St Louis, Missouri 63110, United States
    Recruiting
    • Study Coordinator · Contact314-273-0301
  • HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
    Hackensack, New Jersey 07601, United States
    Recruiting
    • Study Coordinator · Contact551-996-1115
  • Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
    Great Neck, New York 11021, United States
    Recruiting
    • Study Coordinator · Contact516-504-3955
  • Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
    Middletown, New York 12589, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
    New York, New York 10016, United States
    Recruiting
    • Study Coordinator · Contact646-754-3433
  • Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
    New York, New York 10065, United States
    Recruiting
    • Study Coordinator · Contact646-697-0985
  • New York Gastroenterology Associates ( Site 5013)
    New York, New York 10075, United States
    Recruiting
    • Study Coordinator · Contact212-369-2490
  • Northwell Mather Hospital ( Site 5138)
    Port Jefferson, New York 11777, United States
    Recruiting
    • Study Coordinator · Contact631-686-1409
  • University of North Carolina Medical Center ( Site 5034)
    Chapel Hill, North Carolina 27514, United States
    Recruiting
    • Study Coordinator · Contact984-974-3777
  • Atrium Health Gastroenterology MMP ( Site 5105)
    Charlotte, North Carolina 28204, United States
    Recruiting
    • Study Coordinator · Contact704-355-0282
  • Javara - Tryon Medical Partners ( Site 5046)
    Charlotte, North Carolina 28210, United States
    Completed

    Not enrolling at this site — choose another above.

  • Great Lakes Gastroenterology Research, LLC ( Site 5016)
    Mentor, Ohio 44060, United States
    Recruiting
    • Study Coordinator · Contact440-205-1225
  • Digestive Disease Specialists Inc. ( Site 5117)
    Oklahoma City, Oklahoma 73114, United States
    Recruiting
    • Study Coordinator · Contact405-702-1300
  • Penn State University Milton S. Hershey Medical Center ( Site 5102)
    Hershey, Pennsylvania 17033, United States
    Recruiting
    • Study Coordinator · Contact800-243-1455
  • Thomas Jefferson University Hospital ( Site 5133)
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
    • Study Coordinator · Contact609-472-1549
  • Frontier Clinical Research, LLC ( Site 5098)
    Uniontown, Pennsylvania 15401, United States
    Recruiting
    • Study Coordinator · Contact724-550-4099
  • University Gastroenterology - Providence - West River Street ( Site 5057)
    Providence, Rhode Island 02904, United States
    Recruiting
    • Study Coordinator · Contact401-821-6306
  • Sanford USD Medical Center ( Site 5129)
    Sioux Falls, South Dakota 57105, United States
    Recruiting
    • Study Coordinator · Contact605-333-1000
  • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
    Nashville, Tennessee 37204, United States
    Recruiting
    • Study Coordinator · Contact615-322-2312
  • Quality Medical Research ( Site 5114)
    Nashville, Tennessee 37211, United States
    Recruiting
    • Study Coordinator · Contact615-835-4750
  • Baylor University Medical Center ( Site 5031)
    Dallas, Texas 75246, United States
    Recruiting
    • Study Coordinator · Contact214-820-2687
  • GI Alliance - Dallas - Gaston Avenue ( Site 5054)
    Dallas, Texas 75246, United States
    Completed

    Not enrolling at this site — choose another above.

  • Epic Medical Research - Mesquite ( Site 5153)
    Denton, Texas 76201, United States
    Recruiting
    • Study Coordinator · Contact940-252-0504
  • Baylor College of Medicine Medical Center ( Site 5020)
    Houston, Texas 77030, United States
    Recruiting
    • Study Coordinator · Contact713-798-5765
  • Michael E. DeBakey VA Medical Center ( Site 5086)
    Houston, Texas 77030, United States
    Recruiting
    • Study Coordinator · Contact713-798-5765
  • GI Alliance - Lubbock ( Site 5012)
    Lubbock, Texas 79410, United States
    Completed

    Not enrolling at this site — choose another above.

  • Caprock Gastro Research ( Site 5077)
    Lubbock, Texas 79424, United States
    Recruiting
    • Study Coordinator · Contact808-239-1823
  • GI Alliance: Mansfield ( Site 5015)
    Mansfield, Texas 76063, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Southern Star Research Institute ( Site 5000)
    San Antonio, Texas 78229, United States
    Recruiting
    • Study Coordinator · Contact210-581-2812
  • GI Alliance - Southlake ( Site 5109)
    Southlake, Texas 76092-9167, United States
    Recruiting
    • Study Coordinator · Contact817-424-1525
  • Tyler Research Institute ( Site 5001)
    Tyler, Texas 75701, United States
    Recruiting
    • Study Coordinator · Contact903-630-6211
  • Richmond VA Medical Center ( Site 5021)
    Richmond, Virginia 23249, United States
    Recruiting
    • Study Coordinator · Contact804-675-5000
  • Washington Gastroenterology - Bellevue ( Site 5040)
    Bellevue, Washington 98004, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Swedish Medical Center ( Site 5112)
    Seattle, Washington 98104, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Washington ( Site 5115)
    Seattle, Washington 98195, United States
    Recruiting
    • Study Coordinator · Contact414-805-3000
  • Washington Gastroenterology - Tacoma ( Site 5004)
    Tacoma, Washington 98405, United States
    Recruiting
    • Study Coordinator · Contact253-272-5127
  • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)
    Concord, New South Wales 2139, Australia
    Recruiting
    • Study Coordinator · Contact+61 2 9767 5000
  • Royal Brisbane and Women's Hospital ( Site 3200)
    Brisbane, Queensland 4029, Australia
    Recruiting
    • Study Coordinator · Contact+61736468401
  • Mater Misericordiae Limited ( Site 3209)
    Brisbane, Queensland 4101, Australia
    Recruiting
    • Study Coordinator · Contact+61731638195
  • Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)
    Adelaide, South Australia 5000, Australia
    Recruiting
    • Study Coordinator · Contact+61 8 7074 2200
  • Monash Health-Gastroenterology ( Site 3206)
    Clayton, Victoria 3168, Australia
    Recruiting
    • Study Coordinator · Contact+61(0)395943577
  • The Alfred Hospital-Gastroenterology ( Site 3201)
    Melbourne, Victoria 3004, Australia
    Recruiting
    • Study Coordinator · Contact+61(0)390760182
  • Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
    Vienna, State of Vienna 1090, Austria
    Recruiting
    • Study Coordinator · Contact+4314040062450
  • Medizinische Universitaet Innsbruck-Innere Medizin 1 ( Site 0200)
    Innsbruck, Tyrol 6020, Austria
    Recruiting
    • Study Coordinator · Contact0043504813111
  • Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
    Salzburg, 5020, Austria
    Recruiting
    • Study Coordinator · Contact0043(0)572550
  • UZ Gent ( Site 0300)
    Ghent, Oost-Vlaanderen 9000, Belgium
    Recruiting
    • Study Coordinator · Contact+32 9 332 51 66
  • UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
    Leuven, Vlaams-Brabant 3000, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • AZ Delta vzw-Gastroenterology ( Site 0304)
    Roeselare, West-Vlaanderen 8800, Belgium
    Recruiting
    • Study Coordinator · Contact00 32 51 23 72 15
  • Hospital de Clinicas de Porto Alegre ( Site 6310)
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
    • Study Coordinator · Contact55 11 99127 6767

Showing the first 100 of 499 sites across 47 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Timeline

7 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Oct 2028, 52 months after the start.

Of 70 industry-sponsored phase 3 interventional studies under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 69. This study's planned 52 months is above that.

Counting every sponsor, half of 88 studies reached it within 49 months; a quarter within 36 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2024
First posted
May 28, 2024
StartActual
Jun 5, 2024
Primary completionEst.
Oct 30, 2028
CompletionEst.
Nov 12, 2029
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed. 14 sites changed recruiting status (9 now completed, 5 now active, not recruiting)
Show 14 sites
  • Sapporo Medical University Hospital ( Site 3460) · Sapporo, JapanRecruiting→Completed
  • Japanese Red Cross Fukuoka Hospital ( Site 3462) · Fukuoka, JapanRecruiting→Completed
  • Ege Universitesi Hastanesi ( Site 2302) · Bornova, Turkey (Türkiye)Recruiting→Active, not recruiting
  • Nagoya City University Hospital ( Site 3446) · Nagoya, JapanRecruiting→Completed
  • Cliniq s.r.o. ( Site 2001) · Bratislava, SlovakiaRecruiting→Completed
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702) · Le Kremlin-Bicêtre, FranceRecruiting→Completed
  • Amicis Research Center ( Site 5055) · Valencia, United StatesActive, not recruiting→Completed
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100) · Budapest, HungaryRecruiting→Completed
  • GI Alliance: Mansfield ( Site 5015) · Mansfield, United StatesRecruiting→Active, not recruiting
  • Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050) · Middletown, United StatesCompleted→Active, not recruiting
  • Klinička bolnica Merkur ( Site 0503) · Zagreb, CroatiaRecruiting→Completed
  • Klinički bolnički centar Zagreb ( Site 0501) · Zagreb, CroatiaRecruiting→Completed
  • Sapporo Tokushukai Hospital ( Site 3427) · Sapporo, JapanRecruiting→Active, not recruiting
  • Medical Corporation Sapporo IBD Clinic ( Site 3420) · Sapporo, JapanRecruiting→Active, not recruiting
Show site
  • Centro de Investigación y Gastroenterología - S.C. ( Site 3102) · Benito Juarez Ciudad de Mexico, Mexico
Show 1 removed
  • Centro de Investigación y Gastroenterología - S.C. ( Site 3102) · Mexico City, Mexico
across 7 updates, Sep 29, 2026 – Nov 10, 2026
Site contacts
Changed at 12 sites. See the sites
Show 12 sites
  • Sapporo Medical University Hospital ( Site 3460) · Sapporo, JapanContact removed •••2111
  • Japanese Red Cross Fukuoka Hospital ( Site 3462) · Fukuoka, JapanContact removed •••1211
  • Ege Universitesi Hastanesi ( Site 2302) · Bornova, Turkey (Türkiye)Contact removed •••3808
  • Nagoya City University Hospital ( Site 3446) · Nagoya, JapanContact removed •••5511
  • Cliniq s.r.o. ( Site 2001) · Bratislava, SlovakiaContact removed •••2297
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702) · Le Kremlin-Bicêtre, FranceContact removed •••3726
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100) · Budapest, HungaryContact removed •••7237
  • GI Alliance: Mansfield ( Site 5015) · Mansfield, United StatesContact removed •••9664
  • Klinička bolnica Merkur ( Site 0503) · Zagreb, CroatiaContact removed •••1390
  • Klinički bolnički centar Zagreb ( Site 0501) · Zagreb, CroatiaContact removed •••8888
  • Sapporo Tokushukai Hospital ( Site 3427) · Sapporo, JapanContact removed •••1110
  • Medical Corporation Sapporo IBD Clinic ( Site 3420) · Sapporo, JapanContact removed •••0397
across 7 updates, Sep 29, 2026 – Nov 10, 2026
Show all 7 updates
  1. Nov 10, 2026
    5 sites changed recruiting status (3 now active, not recruiting, 2 now completed)
    Show 5 sites
    • Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050) · Middletown, United StatesCompleted→Active, not recruiting
    • Klinička bolnica Merkur ( Site 0503) · Zagreb, CroatiaRecruiting→Completed
    • Klinički bolnički centar Zagreb ( Site 0501) · Zagreb, CroatiaRecruiting→Completed
    • Sapporo Tokushukai Hospital ( Site 3427) · Sapporo, JapanRecruiting→Active, not recruiting
    • Medical Corporation Sapporo IBD Clinic ( Site 3420) · Sapporo, JapanRecruiting→Active, not recruiting
    Site contacts Changed at 4 sites. See the sites
    Show 4 sites
    • Klinička bolnica Merkur ( Site 0503) · Zagreb, CroatiaContact removed •••1390
    • Klinički bolnički centar Zagreb ( Site 0501) · Zagreb, CroatiaContact removed •••8888
    • Sapporo Tokushukai Hospital ( Site 3427) · Sapporo, JapanContact removed •••1110
    • Medical Corporation Sapporo IBD Clinic ( Site 3420) · Sapporo, JapanContact removed •••0397
    + 1 other change: verification date
  2. Nov 2, 2026
    GI Alliance: Mansfield ( Site 5015) is now Active, not recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • GI Alliance: Mansfield ( Site 5015) · Mansfield, United StatesContact removed •••9664
  3. Oct 23, 2026
    2 sites changed recruiting status (2 now completed)
    Show 2 sites
    • Amicis Research Center ( Site 5055) · Valencia, United StatesActive, not recruiting→Completed
    • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100) · Budapest, HungaryRecruiting→Completed
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100) · Budapest, HungaryContact removed •••7237
  4. Oct 20, 2026
    1 site added, 1 site removed. Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702) is now Completed
    Show site
    • Centro de Investigación y Gastroenterología - S.C. ( Site 3102) · Benito Juarez Ciudad de Mexico, Mexico
    Show 1 removed
    • Centro de Investigación y Gastroenterología - S.C. ( Site 3102) · Mexico City, Mexico
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702) · Le Kremlin-Bicêtre, FranceContact removed •••3726
  5. Oct 13, 2026
    2 sites changed recruiting status (2 now completed)
    Show 2 sites
    • Nagoya City University Hospital ( Site 3446) · Nagoya, JapanRecruiting→Completed
    • Cliniq s.r.o. ( Site 2001) · Bratislava, SlovakiaRecruiting→Completed
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Nagoya City University Hospital ( Site 3446) · Nagoya, JapanContact removed •••5511
    • Cliniq s.r.o. ( Site 2001) · Bratislava, SlovakiaContact removed •••2297
  6. Oct 2, 2026
    2 sites changed recruiting status (1 now completed, 1 now active, not recruiting)
    Show 2 sites
    • Japanese Red Cross Fukuoka Hospital ( Site 3462) · Fukuoka, JapanRecruiting→Completed
    • Ege Universitesi Hastanesi ( Site 2302) · Bornova, Turkey (Türkiye)Recruiting→Active, not recruiting
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Japanese Red Cross Fukuoka Hospital ( Site 3462) · Fukuoka, JapanContact removed •••1211
    • Ege Universitesi Hastanesi ( Site 2302) · Bornova, Turkey (Türkiye)Contact removed •••3808
    + 1 other change: verification date
  7. Sep 29, 2026
    Sapporo Medical University Hospital ( Site 3460) is now Completed
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Sapporo Medical University Hospital ( Site 3460) · Sapporo, JapanContact removed •••2111

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06430801
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 28, 2024
Start date
Jun 5, 2024
Primary completion
Oct 30, 2028 (estimated)
Completion
Nov 12, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tulisokibart

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