Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02100696
First received: March 27, 2014
Last updated: March 8, 2017
Last verified: March 2017

March 27, 2014
March 8, 2017
May 31, 2014
January 31, 2019   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 14 ]
  • Percentage of Participants With Remission at Week 66 Among Randomized Participants in Clinical Remission at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
  • Remission as determined by the Mayo Clinic Score (MCS) [ Time Frame: At Week 14 ]
  • Remission maintenance among patients with remission at Week 14. Measured by MCS [ Time Frame: At Week 66 ]
Complete list of historical versions of study NCT02100696 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Clinical Remission at Week 14 (Induction Phase) and Week 66 (Maintenance Phase), as Determined by MCS [ Time Frame: Week 14, 66 ]
  • Percentage of Participants With Clinical Response at Week 14 (Induction Phase) and Week 66 (Maintenance Phase) [ Time Frame: Week 14, 66 ]
  • Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14 (Induction Phase) and Week 66 (Maintenance Phase) [ Time Frame: Week 14, 66 ]
  • Percentage of Participants With Endoscopic Remission at Week 14 (Induction Phase) and Week 66 (Maintenance Phase) [ Time Frame: Week 14, 66 ]
  • Change From Baseline to Week 14 and Week 66 in UC Bowel Movement Signs and Symptoms, as assessed by Ulcerative Colitis Patient-Reported Bowel Movement Signs and Symptoms (UC-PRO/SS) [ Time Frame: Baseline, Week 14, 66 ]
  • Change From Baseline to Week 14 and Week 66 in UC Abdominal Symptoms, as assessed by UC-PRO/SS [ Time Frame: Baseline, Week 14, 66 ]
  • Change From Baseline to Week 14 and Week 66 in Health Related Quality of Life (QoL), as assessed by the Overall Score of Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 14, 66 ]
  • Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants who Were Receiving Corticosteroids at Baseline [ Time Frame: Week 66 ]
  • Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants who Were Receiving Corticosteroids at Baseline [ Time Frame: Week 66 ]
  • Area Under the Serum Concentration-Time Curve (AUC) [ Time Frame: pre-dose (0 hours), post-dose on Week 14, 24, 44, 66 ]
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: pre-dose (0 hours), post-dose on Week 14, 24, 44, 66 ]
  • Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) [ Time Frame: pre-dose on Week 14, 24, 44, 66 ]
  • Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab [ Time Frame: Baseline up to Week 66 ]
Clinical remission as determined by MCS [ Time Frame: At Weeks 14 and 66 ]
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors
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 Are Refractory to or Intolerant of TNF Inhibitors
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: Etrozulimab
    Participants will receive 105 mg administered by subcutaneous injection every 4 weeks.
    Other Name: PRO145223, RO549026
  • Drug: Placebo
    Participants will receive placebo matched with etrolizumab.
  • Experimental: Cohort 1: Etrolizumab (Open-label Induction Phase)
    All participants will receive treatment with open-label etrolizumab 105 milligram (mg) subcutaneous injection every 4 weeks for 14 weeks.
    Intervention: Drug: Etrozulimab
  • Experimental: Cohort 2: Etrolizumab (Double-blind Induction Phase)
    All participants will receive treatment with etrolizumab 105 mg subcutaneous injection every 4 weeks for 14 weeks.
    Intervention: Drug: Etrozulimab
  • Placebo Comparator: Cohort 2: Placebo (Double-blind Induction Phase)
    All participants will receive treatment with placebo matched with etrolizumab.
    Intervention: Drug: Placebo
  • Experimental: Etrolizumab (Maintenance Phase)
    Participants who achieved a clinical response at Week 14 during induction phase (etrolizumab open-label and double blind arm) and randomized to this arm will receive etrolizumab 105 mg subcutaneous injection every 4 weeks up to week 66.
    Intervention: Drug: Etrozulimab
  • Placebo Comparator: Placebo (Maintenance Phase)
    Participants who achieved a clinical response at Week 14 during induction phase (etrolizumab open-label and double blind arm, placebo double blind arm) and are randomized to this arm will receive placebo matched to etrolizumab.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
January 31, 2019
January 31, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • Intolerance, loss response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years
  • 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 multi-matrix system (MMX), 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, 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) and rituximab
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis
  • Evidence of or treatment for Clostridium difficile clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Reference Study ID Number: GA28950 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Spain,   Switzerland,   United Kingdom
 
 
NCT02100696
GA28950
2013-004278-88 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP