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 naIve 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 (GA28948; NCT02163759) was independently conducted.

Key facts

Study ID

NCT02171429

Run by

Hoffmann-La Roche

People needed

358

Starts

2014-11-14

Expected to finish

2020-05-25

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

• Internal Medicine Specialists — Orlando, Florida, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• Footscray Hospital; Gastroenterology — Footscray, Victoria, Australia
• Hospital Universitario Walter Cantidio - UFC — Fortaleza, Ceará, Brazil
• Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia — Salvador, Estado de Bahia, Brazil
• Centro Digestivo de Curitiba — Curitiba, Paraná, Brazil
• Hospital Ernesto Dornelles — Porto Alegre, Rio Grande do Sul, Brazil
• Pesquisare Saúde Sociedade Simples — Santo André, São Paulo, Brazil
• Medical Centre "Asklepii", OOD — Dupnitsa, Bulgaria
• DCC Sv. Pantaleymon OOD — Pleven, Bulgaria
• Medical center Medconsult Pleven OOD — Pleven, Bulgaria
• MHAT - Ruse, AD — Rousse, Bulgaria
• MHAT "Hadzhi Dimitar", OOD — Sliven, Bulgaria
• "City Clinic UMHAC" EOOD — Sofia, Bulgaria
• Medical center CONVEX EOOD — Sofia, Bulgaria
• Medical Center "Nov Rehabilitatsionen Tsentar", EOOD — Stara Zagora, Bulgaria
• MHAT 'Sv. Marina', EAD — Varna, Bulgaria
• RTS - Fundación Valle de Lili — Cali, Colombia
• Center For Digestive Health — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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