RISANKIZUMAB for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Male or Female adult individuals, at least 18 years old (subjects must also meet the legal age of majority per local law) at the baseline visit."}
• {"criterion_text":"- Confirmed diagnosis of CD for at least 3 months prior to Baseline."}
• {"criterion_text":"- Moderately to severely active CD meeting the following disease activity criteria: -CDAI 220 to 450 at Baseline - Endoscopic evidence of mucosal inflammation as documented by a SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are confirmed by a blinded central reader."}
• {"criterion_text":"- Demonstrated intolerance or inadequate response to conventional and/or advanced therapies (biologics or targeted small molecules approved for CD)"}
• {"criterion_text":"- If female, subject must meet the contraception recommendations"}

Exclusion criteria

• {"criterion_text":"- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis."}
• {"criterion_text":"- Subjects with unstable doses of concomitant Crohn's disease therapy"}
• {"criterion_text":"- Receipt of Crohn's disease approved biologic agent or advanced therapeutic agent, or any investigational drug within the period prior to Baseline as detailed in the protocol"}
• {"criterion_text":"- Subjects with complications of CD (abscess, ostomy, ileoanal pouch, short bowel syndrome, etc. as detailed in the protocol"}
• {"criterion_text":"- Prior exposure to p19 inhibitors (e.g.,risankizumab"}

Primary endpoints

• {"endpoint_text":"- Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12","definition_or_measurement_approach":"CDAI clinical remission defined as CDAI < 150 measured at Week 12"}
• {"endpoint_text":"- Achievement of endoscopic response (defined as decrease in SES-CD > 50% from baseline or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer) at Week 12","definition_or_measurement_approach":"Endoscopic response defined as decrease in SES-CD >50% from baseline or (if isolated ileal disease with baseline SES-CD=4) ≥2-point reduction; scoring performed by a blinded central reviewer at Week 12"}

Secondary endpoints

• {"endpoint_text":"- Achievement of SF/APS Clinical remission (defined as average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline) at Week 12","definition_or_measurement_approach":"SF/APS clinical remission defined as average daily SF ≤2.8 and not worse than Baseline AND average daily AP score ≤1 and not worse than Baseline, evaluated at Week 12"}
• {"endpoint_text":"- Achievement of endoscopic remission (defined as SES-CD ≤ 4 and at least a 2-point reduction versus Baseline and no subscore greater than 1 in any individual variable, as scored by a blinded central reviewer) at Week 12","definition_or_measurement_approach":"Endoscopic remission defined as SES-CD ≤4 with ≥2-point reduction vs Baseline and no individual subscore >1, scored by blinded central reviewer at Week 12"}
• {"endpoint_text":"- Achievement of ulcer-free endoscopy (defined as SES-CD ulcerated surface subscore of 0 in subjects with SESCD ulcerated surface subscore ≥ 1 at Baseline, as scored by a blinded central reviewer) at Week 12","definition_or_measurement_approach":"Ulcer-free endoscopy defined as SES-CD ulcerated surface subscore = 0 in subjects who had baseline ulcerated surface subscore ≥1; scored by blinded central reviewer at Week 12"}
• {"endpoint_text":"- Change from Baseline in FACIT-Fatigue at Week 12","definition_or_measurement_approach":"Change from Baseline in FACIT-Fatigue score measured at Week 12"}
• {"endpoint_text":"- Achievement of CR-100 CDAI clinical response (defined as at least a 100-point reduction from Baseline in CDAI) at Week 4","definition_or_measurement_approach":"CR-100 defined as ≥100-point reduction from Baseline in CDAI, evaluated at Week 4"}

Methods

• Hungary: 'K1 M23-784 HU Recruitment and ICF Procedures_Public' (country-specific recruitment procedures)
• Hungary: Main PIS and ICF; Optional Genetic PIS and ICF (country-specific informed consent materials)
• Poland: 'K1_M23-784 PL Recruitment and ICF Procedures_Public' and 'K2_M23-784 PL Online Banner Advertisements_Public' (online banner ads)
• Poland: 'K2_M23-784 PL Patient Flyer_Public', 'K2_M23-784 PL Social Media and Clinical Trial Posts_Public', 'K2_M23-784 PL Patient Brochure_Public' (patient-facing print and social media materials)
• Czechia: 'K1 M23-784 CZ Recruitment and ICF Procedures_Public', 'K2 M23-784 CZ Banner Ads_Public', 'K2 M23-784 CZ Participant Brochure_Public', 'K2 M23-784 CZ Participant Flyer_Public' (banner ads, brochures, flyers)
• Lithuania: 'K1 M23-784 LT Recruitment and ICF Procedures_Public', 'K2 M23-784 LT Participant Study Guide_Public', 'K2 M23-784 LT Visit Reminder Card_Public' (participant guides and visit reminders)

Lithuania

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

315

Number Of Sites

2

Number Of Participants

5

Czechia

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

03-09-2025

Processing Time Days

154

Number Of Sites

3

Number Of Participants

7

Hungary

Earliest CTIS Part Ii Submission Date

10-03-2025

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

171

Number Of Sites

3

Number Of Participants

9

Poland

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

02-09-2025

Processing Time Days

159

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

WCG Clinical Inc.

Responsibilities

Anaphylaxis Adjudication and Cardiovascular Adjudication Committee

Name

Alimentiv Inc.

Responsibilities

Endoscopic and ultrasound Imaging Central Reader

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Central laboratory services (sponsorDuties code: 4)

Name

Medable Inc.

Responsibilities

E-data capture of patient reported daily diary entries and PRO questionnaires

Name

IQVIA Limited

Responsibilities

Operational support (sponsorDuties code: 2)

Name

Greenphire LLC

Responsibilities

Automated patient reimbursement and travel arrangements

Name

Veeva Systems Inc.

Responsibilities

Data systems/vendor support (sponsorDuties code: 7)

Name

Endpoint Clinical Inc.

Responsibilities

Operational support (sponsorDuties code: 3)

Third parties

• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Anaphylaxis Adjudication and Cardiovascular Adjudication Committee","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Endoscopic and ultrasound Imaging Central Reader","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"E-data capture of patient reported daily diary entries and PRO questionnaires","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Automated clinical trial patient reimbursement and travel arrangements","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}