BI 3032950 for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"-Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent"}
• {"criterion_text":"-Diagnosis of UC ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report"}
• {"criterion_text":"-Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason"}
• {"criterion_text":"-Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms"}
• {"criterion_text":"-Further inclusion criteria apply."}

Exclusion criteria

• {"criterion_text":"-Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn’s disease (CD)"}
• {"criterion_text":"-Findings suggestive of CD (e.g. fistulae, granulomas on biopsy)"}
• {"criterion_text":"-Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed"}
• {"criterion_text":"-Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture"}
• {"criterion_text":"-Evidence of fulminant colitis or toxic megacolon at screening"}
• {"criterion_text":"-Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine"}
• {"criterion_text":"-Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator’s judgement after discussion with the sponsor)"}
• {"criterion_text":"-Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery"}
• {"criterion_text":"-Further exclusion criteria apply."}

Primary endpoints

• {"endpoint_text":"-Clinical remission as measured by the modified Mayo score (mMS; defined as mMS of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1) at Week 12","definition_or_measurement_approach":"Measured using the modified Mayo score (mMS) at Week 12; mMS defined as 0–2 with component requirements: SFS 0 or 1, RBS 0, and centrally-read endoscopy subscore (ESS) 0 or 1."}

Secondary endpoints

• {"endpoint_text":"-Endoscopic remission (defined as centrally-read ESS of 0) at Week 12","definition_or_measurement_approach":"Endoscopy centrally read; ESS = 0 at Week 12 indicates endoscopic remission."}
• {"endpoint_text":"-Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1) at Week 12","definition_or_measurement_approach":"Clinical response measured by change in mMS from baseline at Week 12 with specified magnitude criteria and RBS change."}
• {"endpoint_text":"-Endoscopic improvement (defined as centrally-read ESS of 0 or 1) at Week 12","definition_or_measurement_approach":"Centrally-read endoscopy ESS of 0 or 1 at Week 12."}
• {"endpoint_text":"-mMS change from baseline at Week 12","definition_or_measurement_approach":"Change in modified Mayo score from baseline to Week 12."}
• {"endpoint_text":"-SFS of 0 or 1 at Week 12","definition_or_measurement_approach":"Stool frequency subscore (SFS) assessed at Week 12; SFS = 0 or 1."}
• {"endpoint_text":"-RBS of 0 at Week 12","definition_or_measurement_approach":"Rectal bleeding subscore (RBS) assessed at Week 12; RBS = 0."}
• {"endpoint_text":"-Occurrence of treatment-emergent adverse events (AEs) up to Week 12 and up to Week 104","definition_or_measurement_approach":"Recording and reporting of treatment-emergent adverse events up to Week 12 and up to Week 104; safety monitoring over specified timeframes."}

Methods

• Site-based recruitment via participating hospitals/clinics (investigative sites listed for Belgium, Czechia, Poland, Slovakia).
• Study websites (country-specific recruitment websites listed for Belgium, Czechia, Poland, Slovakia).
• Social media (country-specific social media recruitment materials referenced, e.g. K1_CZE Recruitment Social Media Czech, K1_POL Recruitment Social Media Polish, K1_SVK Recruitment Social Media Slovak).
• Printed materials: posters and brochures (country-specific posters and brochures for Belgium, Czechia, Poland, Slovakia).
• Participant information videos (country-specific participant videos listed in recruitment documents).
• Pre-screener/online pre-screening questionnaires (country-specific pre-screener documents listed).
• Advertisements (country-specific adverts in English/Dutch/French/Polish/Czech/Slovak as provided in recruitment documents).
• Recruitment procedure descriptions and site-level recruitment procedures (K1_* Recruitment Procedure Description documents for each country).

Belgium

Earliest CTIS Part Ii Submission Date

12-11-2024

Latest Decision Or Authorization Date

12-12-2024

Processing Time Days

30

Number Of Sites

4

Number Of Participants

9

Czechia

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

92

Number Of Sites

2

Number Of Participants

4

Poland

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

38

Number Of Sites

15

Number Of Participants

29

Slovakia

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

475

Number Of Sites

5

Number Of Participants

14

Primary sponsor

Full Name

Boehringer Ingelheim International GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: 1,11,12,13,2,5,8,9; contact: clinicaltrial.enquiries@parexel.com; phone 0035314739500

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,11,12,13,2,5,8,9; contact: clinicaltrial.enquiries@parexel.com, phone 0035314739500","organisation_type":"Pharmaceutical company"}