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 2: [US/FDA Only] Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12","definition_or_measurement_approach":"Proportion of participants achieving clinical remission assessed by Crohn’s Disease Activity Index (CDAI) score at Week 12."}
• {"endpoint_text":"- Study 2: [EU/EMA Only] Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12","definition_or_measurement_approach":"Proportion of participants achieving clinical remission as defined by stool frequency and abdominal pain score at Week 12 (EU/EMA-specified clinical remission measure)."}
• {"endpoint_text":"- Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12","definition_or_measurement_approach":"Proportion of participants with endoscopic response at Week 12 (endoscopy-based assessment per protocol)."}

Secondary endpoints

• {"endpoint_text":"- Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12","definition_or_measurement_approach":"Proportion of Dx+ subpopulation participants achieving clinical remission per CDAI at Week 12."}
• {"endpoint_text":"- Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12","definition_or_measurement_approach":"Proportion of Dx+ subpopulation participants achieving endoscopic response at Week 12."}
• {"endpoint_text":"- Study 2: Number of Participants Who Experienced an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any adverse event (AE) during the study period."}
• {"endpoint_text":"- Study 2: Number of Participants who Discontinue Study Intervention due to an AE","definition_or_measurement_approach":"Count of participants who discontinued the study intervention because of an adverse event."}
• {"endpoint_text":"- Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12","definition_or_measurement_approach":"Proportion of participants (US/FDA analysis) achieving clinical remission by stool frequency and abdominal pain score at Week 12."}
• {"endpoint_text":"- Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12","definition_or_measurement_approach":"Proportion of participants (EU/EMA analysis) achieving clinical remission per CDAI at Week 12."}
• {"endpoint_text":"- Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12","definition_or_measurement_approach":"Proportion of participants with a decrease of at least 100 points in CDAI from baseline to Week 12."}
• {"endpoint_text":"- Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12","definition_or_measurement_approach":"Mean change from baseline in the Functional Assessment of Chronic Illness Therapy — Fatigue (FACIT-Fatigue) score at Week 12."}
• {"endpoint_text":"- Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12","definition_or_measurement_approach":"Proportion of participants achieving endoscopic remission at Week 12 (endoscopy-based)."}
• {"endpoint_text":"- Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12","definition_or_measurement_approach":"Mean change from baseline in IBDQ score at Week 12."}
• {"endpoint_text":"- Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6","definition_or_measurement_approach":"Proportion of participants with ≥100-point decrease in CDAI from baseline to Week 6."}
• {"endpoint_text":"- Study 2: Percentage of Participants with Ulcer-Free Endoscopy at Week 12","definition_or_measurement_approach":"Proportion of participants with ulcer-free endoscopy at Week 12."}

Methods

• Printed site-level materials: patient brochures, flyers, posters and patient letters to recruit patients at clinic sites (multiple countries: e.g., Romania, Hungary, Italy, Germany, Spain, Poland, Portugal, France, Belgium, Netherlands).
• Website and online recruitment pages: country-specific recruitment websites / landing pages (e.g., Germany website, Portugal website, Netherlands website).
• Social media and online advertising (advertisements, banner ads) — e.g., Germany social media, France website/banner; used to raise awareness and direct to study information pages.
• Community pharmacy materials: community pharmacy landing pages, posters and patient flyers used in Italy (Community Pharmacy materials listed for Italy).
• Patient letters and GP letters: direct mail/letters to patients and GPs to inform about the study (documents listed for Ireland, Italy, France, etc.).
• Call centre and medical services support: EUB services (call center and medical services) provided by Parexel as part of recruitment/support.
• Site referrals and investigator networks: recruitment via participating hospitals/IBD clinics and investigator referral (numerous hospital sites listed per country).
• Patient advocacy engagement: liaison with patient organisations/advocacy groups to support awareness (see specific patient organisation sites).

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

Syneos Health Clinique Inc.

Responsibilities

Central or operational support listed (central imaging duties noted for Alimentiv; Syneos listed as third party with role code 4).

Name

PPD International Holdings LLC

Responsibilities

Operational support (sponsor duties code present in CTIS entry).

Name

Medidata Solutions Inc.

Responsibilities

Electronic data and participant platform support (listed sponsor duties code in CTIS).

Third parties

• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sponsor duties code: 4 (role code listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Sponsor duties code: 3 (role code listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Sponsor duties code: 4 (role code listed in CTIS)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code: 7 (role code listed in CTIS)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Sponsor duties code: 4 (role code listed in CTIS)","organisation_type":"Pharmaceutical company"}