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

PHASE3RECRUITING

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).

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  2. Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
  3. 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.
  4. Has current stoma or need for colostomy or ileostomy.
  5. Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
  6. Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
  7. Has surgical bowel resection within 3 months of study.
  8. Has prior or current gastrointestinal dysplasia.
  9. Has chronic infection requiring ongoing antimicrobial treatment.
  10. 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.
  11. Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  12. Has active tuberculosis.
  13. Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
  14. Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT06430801

Intervention or treatment

DRUG: IV Tulisokibart

DRUG: SC Tulisokibart

OTHER: IV Placebo

OTHER: SC Placebo

Conditions

  • Crohn's Disease

  • Condition: Crohn's Disease

  • DRUG: IV Tulisokibart and other drugs

  • Concord, New South Wales, Australia and more

  • Sponsor: Merck Sharp & Dohme LLC

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Research sites nearby

Closest Location:

Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)

Select from list below to view details:

  • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)

    Concord, New South Wales, Australia

  • Royal Brisbane and Women's Hospital ( Site 3200)

    Brisbane, Queensland, Australia

  • Mater Misericordiae Limited ( Site 3209)

    Brisbane, Queensland, Australia

  • Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)

    Adelaide, South Australia, Australia

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Who is running the clinical trial?

MS&DL

Merck Sharp & Dohme LLC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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

                        What is the study measuring?

                        Primary Outcome

                        MeasureDescriptionTime Frame
                        Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.Week 52
                        Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.Week 12
                        Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12The 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.Week 12
                        Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 1 will be presented.Week 12
                        Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.Week 12
                        Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12The 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.Week 12
                        Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 2 will be presented.Week 12

                        Secondary Outcome

                        MeasureDescriptionTime Frame
                        Study 1: Percentage 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 percentage of participants who experience an AE for study 1 will be presented.Up to approximately 52 weeks
                        Study 1: Percentage of Participants who Discontinue Study Intervention due to an AEAn 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 percentage of participants who discontinue study intervention due to an AE for study 1 will be presented.Up to approximately 52 weeks
                        Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12The 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.Week 12
                        Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.Week 12
                        Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12The percentage of participants achieving a reduction in CDAI ≥100 points from baseline for study 1 will be presented.Week 12
                        Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12The 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.Baseline and Week 12
                        Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12The 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.Week 12
                        Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12Dx+ 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.Week 12
                        Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12Dx+ 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.Week 12
                        Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.Week 52
                        Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 1 will be presented.Week 52
                        Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for study 1 will be presented.Week 12 and Week 52
                        Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52The 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.Week 52
                        Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52The 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.Week 52
                        Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52The 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.Baseline and Week 52
                        Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52The 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.Baseline and Week 52
                        Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52The 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.Week 52
                        Study 2: Percentage of Participants Who Experienced an AEAn 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 percentage of participants who experience an AE for study 2 will be presented.Up to approximately 12 weeks
                        Study 2: Percentage of Participants who Discontinue Study Intervention due to an AEAn 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 percentage of participants who discontinue study intervention due to an AE for study 2 will be presented.Up to approximately 12 weeks
                        Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12The 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.Week 12
                        Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.Week 12
                        Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.Week 12
                        Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12The 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.Baseline and Week 12
                        Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12The 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.Week 12
                        Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12The 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.Baseline and Week 12
                        Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.Week 6
                        Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12The 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.Week 12
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                        References

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

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