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A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Autoimmune Disorder Inflammatory Bowel Disease (IBD) Ulcerative Colitis
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT02100696, GA28950, 2013-004278-88
Condition
Ulcerative Colitis
Official Title
Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Study Summary
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.
Eligibility Criteria
All
≥ 18 Years & ≤ 80 Years
No
Inclusion Criteria
- Diagnosis of UC established at least 3 months prior to Day 1
- Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
- Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
- Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
- Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
- Use of highly effective contraception as defined by the protocol
- Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
Exclusion Criteria
- A history of or current conditions and diseases affecting the digestive tract, such as 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
- Prior or planned surgery for UC
- Past or present ileostomy or colostomy
- Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
- Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
- Any prior treatment with rituximab
- Any treatment with tofacitinib during screening
- Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
- Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
- Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
- History of recurrent opportunistic infections and/or severe disseminated viral infections
- History of organ transplant
- Any major episode of infection requiring treatment with intravenous (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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS_GA28950_HICKORY_interim results_October2021_English
(PDF, 0.7 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_cze
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_dan
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_dut-BE
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_dut-NL
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_fre-CA
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_ger-AT
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_ger-DE
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_gre
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LPS_GA28950_HICKORY_final results_20Oct2021_English_heb
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LPS_GA28950_HICKORY_final results_20Oct2021_English_hun
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LPS_GA28950_HICKORY_final results_20Oct2021_English_ita-IT
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LPS_GA28950_HICKORY_final results_20Oct2021_English_kor
(PDF, 0.6 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_pol
(PDF, 0.5 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_por-BR
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LPS_GA28950_HICKORY_final results_20Oct2021_English_rum
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LPS_GA28950_HICKORY_final results_20Oct2021_English_spa-ES
(PDF, 0.4 MB)
LPS_GA28950_HICKORY_final results_20Oct2021_English_spa-LA
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LPS_GA28950_HICKORY_final results_20Oct2021_English_fre-FR
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For the latest version of this information please go to www.forpatients.roche.com