- Title: Efficacy and safety of Etrolizumab, an AlphaE beta7 inhibitor, in moderate to severe CD
- Study drug: Etrolizumab
- Sponsor: Roche
- Participating centers and contact: Insel Bern, PD Dr. med. Pascal Juillerat (Pascal.Juillerat@insel.ch)
- Target population: Moderate to severe CD
- Primary outcome:
- 1. Induction Phase: Percentage of Participants with Clinical Remission at Week 14 [ Time Frame: Baseline and Week 14 ]
- Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
- 2. Induction Phase: Percentage of Participants with Endoscopic Improvement at Week 14 [ Time Frame: Baseline and Week 14 ]
- Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
- 3. Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66 [ Time Frame: Baseline and Week 66 ]
- Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
- 4. Maintenance Phase: Percentage of Participants with Endoscopic Improvement at Week 66 [ Time Frame: Baseline and Week 66 ]
- Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score.
- Inclusion criteria:
- Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
- Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
- Use of effective contraception as defined by the protocol
- Exclusion criteria:
- A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
- Planned surgery for CD
- Ileostomy or colostomy
- Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
- Any prior treatment with ustekinumab within 14 weeks prior to randomization
- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)
- Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
- Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])
- Any major episode of infection requiring treatment with intravenous antibiotics ≤8 weeks prior to screening or oral antibiotics ≤4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
- Hospitalization (other than for elective reasons) within 4 weeks prior to randomization
- More information: https://www.clinicaltrials.gov/ct2/show/NCT02394028?term=Etrolizumab&cntry=CH&draw=2&rank=2