TULISOKIBART for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Has had a diagnosis of Crohn’s Disease (CD) at least 3 months before study.\n- Has moderately to severely active CD.\n- 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.\n- Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Study 1 [US/FDA]: Percentage of Participants Achieving Clinical Remission per Crohn’s Disease Activity Index (CDAI) Score at Week 52","definition_or_measurement_approach":"Assessed as the proportion of participants achieving clinical remission according to the Crohn’s Disease Activity Index (CDAI) score at Week 52."}
• {"endpoint_text":"- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52","definition_or_measurement_approach":"Assessed as the proportion of participants achieving clinical remission defined by stool frequency and abdominal pain score at Week 52."}
• {"endpoint_text":"- Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52","definition_or_measurement_approach":"Assessed as the proportion of participants achieving endoscopic response at Week 52 (endoscopic scoring per protocol)."}
• {"endpoint_text":"- Study 1 [US/FDA only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12","definition_or_measurement_approach":"Assessed as the proportion of participants achieving clinical remission per CDAI score at Week 12."}
• {"endpoint_text":"- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12","definition_or_measurement_approach":"Assessed as the proportion of participants achieving clinical remission defined by stool frequency and abdominal pain score at Week 12."}
• {"endpoint_text":"- Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12","definition_or_measurement_approach":"Assessed as the proportion of participants achieving endoscopic response at Week 12."}

Secondary endpoints

• {"endpoint_text":"- Study 1: Number of Participants Who Experienced an Adverse Event (AE)\n- Study 1: Number of Participants who Discontinue Study Intervention due to an AE\n- Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12\n- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12\n- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12\n- Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) Score at Week 12\n- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12\n- Study 1: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12\n- Study 1: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12\n- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52\n- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52\n- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52\n- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52\n- Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Week 12 and Week 52\n- Study 1 [US/FDA]:: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52\n- Study 1 [EU/EMA]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52\n- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52\n- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52\n- Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52\n- Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52\n- Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52","definition_or_measurement_approach":"Definitions are study-specified; secondary endpoints include safety (number with AEs, discontinuations for AEs) and efficacy measures assessed by CDAI, stool frequency and abdominal pain scores, endoscopic response/remission, change from baseline in PROs (FACIT-Fatigue, IBDQ), and corticosteroid-free remission at specified timepoints (Week 12, Week 52). Dx+ subpopulation analyses are by Diagnostic Assay Positive status."}

Methods

• Patient brochures, patient flyers and patient brochures (country-specific materials available: e.g. GRC, IRL, HUN, ITA, NLD, PRT, FRA, DEU, SWE, CZE, POL, ESP, AUT).
• Posters and leave-behind materials for clinics and community pharmacies (country-specific).
• Banner ads and patient banner advertisements (digital).
• Website landing pages (study-specific recruitment landing pages).
• Social media recruitment materials (country-specific social media content).
• Patient letters and study fact sheets provided to potential participants.
• Advocacy / outreach cards and materials for patient advocacy groups.

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

PPD International Holdings LLC

Responsibilities

Local CRO services (sponsor duties code: 4)

Name

Syneos Health Clinique Inc.

Responsibilities

CRO services (sponsor duties code: 4)

Third parties

• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Laboratory services (sponsor duties code: 4)","organisation_type":"Pharmaceutical company (laboratory service provider)"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Hospital/Clinic/Other health care facility (CRO)"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Pharmaceutical company (vendor; eCOA)"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company (CRO)"}
• {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company (vendor — central imaging)"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA, calculation of CDAI score and integration with PPD for hematocrit","organisation_type":"Non-Pharmaceutical company (vendor — eCOA/electronic data)"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company (CRO)"}