PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS

Phase 3

Completed

• Conditions: inflammatory bowel disease; Ulcerative colitis; 10017969

• Registration Number: NL-OMON47727
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

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 or intolerance of prior corticosteroid and/or immunosuppressant treatment
- Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
- 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;A complete list of inclusion criteria can be found in the protocol

Exclusion Criteria

- Prior extensive colonic resection, subtotal colectomy, or planned surgery for UC
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
- Prior or planned surgery for UC
- Any prior treatment with anti-adhesion molecules
- Past or present ileostomy or colostomy
- 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;- Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent);A complete list of exclusion criteria can be found in the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Outcome Measure<br /><br>* Both clinical response at W 10 and clinical remission at W 54 in patients<br /><br>with ulcerative colitis as determined by Mayo clinic score (MSC)</p><br>