ICOTROKINRA for Ulcerative colitis | Moderately to severely active ulcerative colitis

Inclusion criteria

• {"criterion_text":"- 1. Adult participants: ≥18 years of age (and at least the legal age of consent in the jurisdiction in which the study is taking place). Adolescent participants: ≥12 to <18 years of age, at the time of signing the informed assent/consent\n- 2. Diagnosis of UC established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.\n- 3. Moderately to severely active UC, defined as baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.\n- 4. An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy.\n- 5.A participant who has had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥ 10 years before the first dose of study intervention must undergo a complete colonoscopy to assess for the presence of dysplasia within 1 year before the first dose of study intervention. Completion of the colonoscopy with dysplasia assessment is allowed during the screening period prior to the first dose of study intervention."}

Exclusion criteria

• {"criterion_text":"- 1. Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study.\n- 2. Presence of a stoma.\n- 3. Presence or history of fistula.\n- 4. Colonic resection within 24 weeks before baseline or any other intra abdominal or other major surgery performed within 12 weeks before baseline.\n- 5. History or screening colonoscopy finding of high- or low-grade colonic mucosal dysplasia in an area of known colitis (active or historic)."}

Primary endpoints

• {"endpoint_text":"- Induction study (adult): Clinical remission at Week I-12\n- Maintenance study (adult): Clinical remission at Week M-40\n- Adolescent study: Clinical remission at Week M-40","definition_or_measurement_approach":"Not specified in the CTIS record. (Endpoint text lists clinical remission at the specified weeks; measurement definition not provided in the extracted fields.)"}

Methods

• Digital Ad Templates / Display Ads — digital recruitment materials are listed (templates) for multiple countries (examples in document list for BE, CZ, DE, FR, NL, SE, etc.); target audience: potential participants and parents of adolescent participants.
• Recruitment flyers — country-specific recruitment flyers including adolescent-targeted flyers (documents present for BE, CZ, DE, FR, IT, NL, PT, PL, ES, SE etc.).
• Study Information Brochures — participant information brochures for adults and adolescents provided in multiple languages and countries.
• Dear Parent Email — email template for parents/guardians (country-specific versions e.g., CZ, PT, DE listed).
• Subject Wallet Card — wallet card provided to subjects (country-specific).
• IUS Sub-study Fact Sheets and optional sub-study recruitment material — separate materials for optional imaging/substudy recruitment and adolescent optional sub-study.

Primary sponsor

Full Name

Janssen Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Eresearchtechnology Inc.

Responsibilities

eCOA

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central laboratory services (sponsor duty code present)

Name

4g Clinical LLC

Responsibilities

Vendor/CRO duties (sponsor duty code present)

Name

Bioclinica Inc.

Responsibilities

Imaging

Name

Eresearchtechnology Inc.

Responsibilities

Central ECG

Third parties

• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"(code 4) - specified duty code present in record","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"(code 3) - specified duty code present in record","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}