Icotrokinra (ICOTROKINRA) for Moderately to severely active Crohn's disease

Inclusion criteria

• {"criterion_text":"- Aged ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place).\n- Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD. The participant must have endoscopic evidence of colitis, ileitis, or ileocolitis. Histopathology results supporting the diagnosis of CD, if unavailable, may be obtained during screening and should be interpreted locally.\n- Moderately to severely active CD based on CDAI criteria, defined as: Baseline (Week I-0) CDAI score ≥220 but ≤450 AND EITHER: Mean daily SF count ≥4, based on the unweighted CDAI component of the number of liquid or very soft stools OR Mean daily AP score ≥2, based on the unweighted CDAI component of abdominal pain.\n- Moderately to severely active CD based on SES-CD criteria, defined as: Baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD ≥6 for participants with colonic or ileocolonic disease, and SES-CD ≥4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: A minimum score of 1 for the component of “size of ulcers” AND A minimum score of 1 for the component of “ulcerated surface”.\n- Demonstrated an inadequate response, loss of response, or intolerance to previous conventional therapy (ADT-naïve) or ADT (defined as biologics and/or advanced oral agents for the treatment of CD; ADT-IR): Conventional therapies: Oral corticosteroids (including budesonide and beclomethasone dipropionate); Thiopurines (ie, AZA, 6-MP, thioguanine) or MTX. Advanced therapies (biologics or oral advanced therapies): Anti-TNFα antibodies (ie, infliximab, adalimumab, certolizumab or biosimilars); Anti-integrin antibodies (ie, vedolizumab, or biosimilars); Anti-IL-12/23 (p40) antibodies (ie, ustekinumab or biosimilars); JAK inhibitors (ie, upadacitinib)."}

Exclusion criteria

• {"criterion_text":"- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention.\n- Colonic resection within 24 weeks before baseline or any other intra-abdominal or major surgery performed within 12 weeks before baseline\n- History or screening colonoscopy finding of high or low grade colonic mucosal dysplasia in an area of known colitis (active or historic). Participants will not be excluded for a pathology finding of indefinite dysplasia with reactive atypia.\n- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC.\n- Presence of a draining or functioning stoma or ostomy."}

Primary endpoints

• {"endpoint_text":"- Phase 2b Induction: clinical response at Week I-12\n- Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12\n- Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40","definition_or_measurement_approach":"Clinical response/remission endpoints assessed at specified weeks using CDAI-based clinical scoring; endoscopic response assessed by ileocolonoscopy with central review using SES-CD criteria (SES-CD thresholds defined in eligibility and central endoscopic assessment)."}

Methods

• Country-specific recruitment arrangements documents provided (recruitment arrangements, recruitment flyers, study information brochures).
• Digital recruitment: digital advertisement templates and digital ad materials (digital recruitment templates present in document list).
• Traditional printed materials: recruitment flyers and study information brochures for participants.
• Site-based recruitment through participating hospitals/clinics and IBD centres (local site contact details provided in Part II submissions).

Primary sponsor

Full Name

Janssen Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Bioclinica Inc.

Responsibilities

Imaging

Name

Eresearchtechnology Inc.

Responsibilities

eCOA; Central ECG

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central laboratory services

Name

4g Clinical LLC

Responsibilities

Study operations / other sponsor duties

Third parties

• {"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":"eCOA; Central ECG (two entries for eResearchTechnology with differing duty codes: eCOA and Central ECG)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Study operations / other sponsor duties","organisation_type":"Non-Pharmaceutical company"}