A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2013-004282-14-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-15
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

- 18-80 years of age, inclusive.
- Diagnosis of UC established at least 3 months prior to Day 1 by clinical and endoscopic evidence
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- Evidence of UC extending a minimum of 20 cm from the anal verge as determined by baseline endoscopy
- Naive to treatment with any anti-TNF inhibitor therapy
- An inadequate response to, loss of response to, or intolerance to prior corticosteroid and/or immunosuppressant treatment
- Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budenoside, probiotics, azathioprine (AZA), 6-mercaptopurine(6-MP), or methotrexate (MTX) if doses are stable, as defined by the protocol
- Use of highly effective contraception as defined by the protocol
- Received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- A history of or current conditions and diseases affecting the digestive tract, such as ileostomy or colostomy indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous
colonic polyps
- Have received non-permitted inflammatory bowel disease (IBD) therapies (including etrolizumab or other anti-integrin agents such as natalizumab, vedolizumab, and efalizumab), as stated in the protocol
- Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
- Any prior treatment with rituximab
- Any treatment with tofacitinib during screening
- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies, fusion proteins, or murine proteins or hypersensitivity to etrolizumab or any of the excipients
- Neurologic conditions or diseases that may interfere with monitoring for PML
- History of demyelinating disease
- Clinically significant abnormalities on screening neurologic examination (PML Objective/Subjective Checklists)
- History of cancer, including hematologic malignancy, solid tumors, and carcinoma in situ, within 5 years before screening, as defined by the protocol
- Congenital or acquired immune deficiency, chronic hepatitis B or C infection, HIV positive or history of tuberculosis (active or latent)
- Evidence of or treatment for Clostridium difficile (as assessed by C. difficile toxin testing) within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1.
- Evidence of or treatment for clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1.
- History of recurrent opportunistic infections and/or history of severe disseminated viral infections, or organ transplant
- Any serious opportunistic infection within the last 6 months
- Any major episode of infection requiring treatment with IV antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
- Received a live attenuated vaccine within 4 weeks prior to Day 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified