A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

Key facts

Study ID

NCT02163759

Run by

Hoffmann-La Roche

People needed

358

Starts

2014-11-04

Expected to finish

2020-03-19

Last updated by the study team

2021-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of ulcerative colitis (UC) established at least 3 months prior to randomization (Day 1)
• Moderately to severely active UC as determined by the MCS
• Naive to treatment with TNF inhibitor therapy
• An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
• Background UC therapy may include oral 5-aminosalisylate (5-ASA), budesonide, oral corticosteroids, probiotics, azathioprine (AZA), 6-mercaptopurine (6MP), or methotrexate (MTX) if doses have been stable for:
• AZA, 6-MP, MTX: 8 weeks immediately prior to randomization
• 5-ASA: 4 weeks immediately prior to randomization
• Corticosteroids: 4 weeks immediately prior to randomization; if corticosteroids are being tapered, dose has to be stable for at least 2 weeks prior to randomization
• Use of highly effective contraception method as defined by the protocol
• Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

You may not qualify if…

• Exclusion Criteria Related to Inflammatory Bowel Disease:
• Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
• Past or present ileostomy or colostomy
• Diagnosis of indeterminate colitis
• Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
• Diagnosis of toxic megacolon within 12 months of initial screening visit
• Any diagnosis of Crohn's disease
• Past or present fistula or abdominal abscess
• A history or current evidence of colonic mucosal dysplasia
• Patients with any stricture (stenosis) of the colon
• Patients with history or evidence of adenomatous colonic polyps that have not been removed
• Exclusion Criteria Related to Prior or Concomitant Therapy:
• Prior treatment with TNF-alpha antagonists
• Any prior treatment with etrolizumab or other anti-integrin agents
• Any prior treatment with rituximab
• Any treatment with tofacitinib during screening
• Any prior treatment with anti-adhesion molecules
• Use of intravenous (IV) steroids within 30 days prior to screening with the exception of a single administration of IV steroid
• Use of agents that deplete B or T cells
• Use of anakinra, abatacept, cyclosporine, sirolimus, or mycophenolate mofetil (MMF) within 4 weeks prior to randomization
• Chronic nonsteroidal anti-inflammatory drug (NSAID) use
• Patients who are currently using anticoagulants including, but not limited to, warfarin, heparin, enoxaparin, dabigatran, apixaban, rivaroxaban
• Patients who have received treatment with corticosteroid enemas/suppositories and/or topical (rectal) 5-ASA preparations within 2 weeks prior to randomization
• Apheresis (i.e., Adacolumn apheresis) within 2 weeks prior to randomization
• Received any investigational treatment including investigational vaccines within 5 half lives of the investigational product or 28 days after the last dose, whichever is greater, prior to randomization

Where it is running

• Center for Advanced Gastroenterology — Maitland, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Center for Digestive Health — Troy, Michigan, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Wellness Clinical Research Center — San Antonio, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• Instituto Medico DAMIC — Córdoba, Argentina
• Bankstown-Lidcombe Hospital — Bankstown, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Mater Hospital Brisbane — South Brisbane, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• CCBR - Brasilia — Brasília, Federal District, Brazil
• Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda — Goiânia, Goiás, Brazil
• Hospital Felicio Rocho — Belo Horizonte, Minas Gerais, Brazil
• Hospital Universitario Clementino Fraga Filho - UFRJ — Rio de Janeiro, Rio de Janeiro, Brazil
• Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
• UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu — Botucatu, São Paulo, Brazil
• UMHAT "Sv. Ivan Rilski", EAD — Sofia, Bulgaria
• UMHAT Tsaritsa Yoanna - ISUL, EAD — Sofia, Bulgaria
• MC Medica Plus — Veliko Tarnovo, Bulgaria
• Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

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