Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: spesolimab
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Spesolimab
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 - 75 years, at date of signing informed consent, males or females 2. Diagnosis of ulcerative colitis = 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report 3. Moderate to severe activity (total MCS 6 to 12 with a RBS = 1 AND an SFS = 1 AND mESS = 2 within 7-28 days prior to first dose) 4. Endoscopic activity extending proximal to the rectum (= 15 cm from anal verge) 5.Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNF? agonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past as per definition in the CTP Appendix 10.6 6. May be receiving a therapeutic dose of the following: - Oral 5-ASA compounds, provided that dose has been stable for at least the 4 weeks immediately prior to randomisation, and/or - Oral corticosteroids (= 20 mg per day of prednisone or equivalent), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or - Oral budesonide (= 9 mg per day ) or beclomethasone dipropionate (= 5 mg per day), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or - Azathioprine, 6-MP or methotrexate, provided that dose has been stable for the 8 weeks immediately prior to randomisation. - Probiotics (e.g. S. boulardii) provided that dose has been stable for the 4 weeks immediately prior to randomisation. 7. Patients with extensive colitis or pancolitis of >10 years duration or family history of colorectal cancer or personal history of increased colorectal cancer risk must have had a negative colorectal cancer screening within =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Evidence of abdominal abscess at screening 2. Evidence of fulminant colitis or toxic megacolon at screening 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine 4. Treatment with: •any non-biologic medication (e.g. cyclosporine, tacrolimus or mycophenolate mofetil, intavenous corticosteroids, tofacitinib), •any biologic treatment with a TNFa antagonist (adalimumab, infliximab, golimumab) or vedolizumab within 8 weeks prior to randomisation. (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomization, patient can be enrolled despite not having completed 8 weeks from last treatment.) •rectal 5-ASA, parenteral or rectal corticosteroids (incl. budesonide) within 2 weeks prior to screening •any investigational non-biologic drug for UC (including but not limited to JAK inhibitors, S1P modulators) within 30 days prior to randomisation •any investigational biologic for UC (including IL-12 and IL-23 inhibitors; etrolizumab) ithin 8 weeks (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomization, patient can be enrolled despite not having completed 8 weeks from last treatment.) •any prior exposure to BI 655130, natalizumab or rituximab 5. Positive stool examinations for C. difficile or other intestinal pathogens 3years); patients with remote history of malignancy (=5 years prior) may be considered and have to be discussed with sponsor case-by-case 15. Major surgery (major according to the investigator’s assessment) performed within 12 weeks prior to randomization or planned during study conduct, e.g. hip replacement. 16. P
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II);Secondary Objective: - To confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368- 0020, the target population to be evaluated in the randomised withdrawal study 1368- 0020.;Primary end point(s): 1. Part 1 and Part 2: Proportion of patients with Clinical Remission at week 12 (defined as mMCS SFS=0 or 1, if drop =1 from BL; and RBS=0; and mESS=1);Timepoint(s) of evaluation of this end point: 1. Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Part 2/Phase III only: Proportion of patients with Mucosal Healing at week 12 (defined as mESS = 1) 2. Part 2/Phase III only: Change in IBDQ score from baseline at week 12 3. Part 1 and Part 2: Proportion of patients with combined Mucosal healing and histologic remission at week 12 (defined as mESS = 1 and Robarts Histology Index = 6) 4. Part 2/Phase II only: Proportion of patients with Mucosal Healing at week 12 5. Part 2/Phase II only: Proportion of patients with Clinical response at week 12;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 0 and Week 12 3. Week 12 4. Week 12 5. Week 12 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Boehringer Ingelheim International GmbH
Outcome results
None listed