A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03123120
• Date of registration: 13/04/2017
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
• Scientific title: Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy
• Date of first enrolment: June 7, 2017
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03123120
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Denmark, Germany, Ireland, Netherlands, Norway, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria

- 18 - 75 years at screening and randomisation

- Diagnosis of ulcerative colitis >= 5 months prior to screening

- Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4
months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation

- Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)

- Further inclusion criteria apply

Exclusion Criteria:

- Prior use of more than two different TNF inhibitors or vedolizumab

- Extensive colonic resection

- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to
screening

- Active or latent tuberculosis

- Further exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: Spesolimab

Primary Outcome(s)

Mucosal healing (MCS (Mayo Score) mESS (Modified endoscopic subscore) <=1) at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Histological remission (Robarts (RHI (Robarts Histopathology Index)) score <=6) at Week 12 [Time Frame: Week 12]

Treatment emerging adverse events [Time Frame: Up to Week 36]

Clinical remission based on Mayo score (total MCS (Mayo Score) <=2 points, and all subscores <=1 point) at Week 12 [Time Frame: Week 12]

Modified clinical remission based on Mayo score (total modified MCS (Mayo Score)<=2 and: RBS (Rectal Bleeding Subscore) =0, Stool Frequency Score (SFS) =0 or 1 and drop >=1 from baseline, AND mESS (Modified endoscopic subscore) <=1) at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

1368-0010

2016-004572-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors