RISANKIZUMAB for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Subject has confirmed diagnosis of Ulcerative Colitis for at least 3 months prior to Baseline."}
• {"criterion_text":"- Subject has active Ulcerative Colitis with an modified Mayo Score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader)"}
• {"criterion_text":"- Subject has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators."}

Exclusion criteria

• {"criterion_text":"- Subject with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis."}
• {"criterion_text":"- Subject has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab."}
• {"criterion_text":"- Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator."}

Primary endpoints

• {"endpoint_text":"- Achievement of endoscopic improvement at Week 48, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): superiority of risankizumab vs. vedolizumab.","definition_or_measurement_approach":"Endoscopic improvement measured at Week 48 by centrally read endoscopy subscore of 0 or 1. Score of 1 is modified to exclude friability. Superiority comparison risankizumab vs vedolizumab."}

Secondary endpoints

• {"endpoint_text":"- The achievement of clinical remission per mMS at Week 48, defined as SFS ≤ 1 and not greater than Baseline, RBS = 0, and a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): non-inferiority of risankizumab vs. vedolizumab test first followed by superiority test.","definition_or_measurement_approach":"Clinical remission by modified Mayo Score (mMS) at Week 48 defined as Stool Frequency Subscore (SFS) ≤1 and not greater than baseline, Rectal Bleeding Subscore (RBS) = 0, and centrally read endoscopy subscore of 0 or 1 (1 modified to exclude friability). Testing hierarchy: non-inferiority first, then superiority."}

Methods

• Participant brochures (country-specific) — printed or electronic informational brochures targeted at patients with moderate to severe ulcerative colitis (examples: 'Participant Brochure' documents for multiple countries).
• Participant flyers and posters — short-format recruitment materials targeted at potential participants (documents named 'Participant Flyer' and 'Participant Poster' for DE, ES, AT, IE, SE, etc.).
• Dr-to-Patient / Physician referral letters — letters for clinicians to inform or refer eligible patients (documents include 'Dr-to-Patient Letter' and 'Physician Referral Letter').
• Recruitment and ICF Procedures documents (K1) — country-specific recruitment procedures and ICF workflow described per country (documents exist for DE, SK, ES, AT, FR, NL, IE, LV, CZ, IT, SE, BG, HU, PL, EE, HR, LT, RO, FI, SI and others).
• Video script (DarmPlus Video Script) — a video recruitment/scripted material referenced for Austria (suggests use of video channel for outreach).
• Country-specific recruitment materials and lay summaries: the CTIS documents include country-specific recruitment packs indicating targeted local-language recruitment approaches in participating countries.

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Iqvia Biotech LLC

Responsibilities

Recruitment; clinical operations (as listed in sponsor third parties)

Name

Medidata Solutions Inc.

Responsibilities

eCOA

Name

Labcorp Central Laboratory Services LP

Responsibilities

Laboratory services

Name

Veeva Systems Inc.

Responsibilities

Data systems / CDMS support

Third parties

• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Endoscopies. Biopsies & IUS","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Clinical duties (Recruitment; other listed duties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Cardiac Adjudication Committee","organisation_type":"Industry"}