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A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

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ClinicalTrials.gov Identifier: NCT02165215
Recruitment Status : Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 13, 2014
First Posted Date  ICMJE June 17, 2014
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE August 12, 2014
Estimated Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10 as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 62 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Maintenance of remission among randomized patients in remission at Week 10 as determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 62 ]
Change History Complete list of historical versions of study NCT02165215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Percentage of Participants who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission at Week 10 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants in Clinical Remission at Week 62 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants With Clinical Response at Week 62 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants With Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 62 [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants With Endoscopic Remission at Week 62 [ Time Frame: Week 62 ]
  • Percentage of Participants With Corticosteroid-free Clinical Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants With Corticosteroid-free Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants With Histologic Remission at Week 62 [ Time Frame: Week 62 ]
  • Change from Baseline to Week 62 in UC Bowel Movement Signs and Symptoms as Assessed by the UC-Patient Reported Outcome Signs and Safety (UC-PRO/SS) Measure [ Time Frame: Baseline, Week 62 ]
  • Change From Baseline to Week 62 in UC Abdominal Symptoms as Assessed by the UC-PRO/SS Measure [ Time Frame: Baseline, Week 62 ]
  • Change From Baseline to Week 62 in Health-Related Quality of Life (HRQOL) as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 74 ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Baseline up to Week 62 (assessed at Weeks 4, 12, 24, 44, and 62) ]
  • Serum Trough Concentration of Etrolizumab During Dosing Period from Week 12 to Week 62 [ Time Frame: Prior to administration of etrolizumab injection (0 hour) at Weeks 12, 24, 44, and 62 ]
  • Serum Concentration of Etrolizumab at Week 62 [ Time Frame: Prior to administration of etrolizumab injection (0 hour) at Week 62 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
  • Maintenance of clinical remission among randomized patients in clinical remission at Week 10 as determined by the MCS [ Time Frame: Week 62 ]
  • Clinical remission as determined by the MCS [ Time Frame: Week 62 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
Official Title  ICMJE Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Brief Summary This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: Etrolizumab
    Participants will receive 105 mg etrolizumab SC injection Q4W.
  • Drug: Placebo
    Participants will receive etrolizumab matching placebo Q4W.
Study Arms  ICMJE
  • Experimental: Etrolizumab (Maintenance Phase)
    Participants who achieved a clinical response at Week 10 during induction phase and randomized to this arm will receive etrolizumab 105 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) up to Week 62.
    Intervention: Drug: Etrolizumab
  • Experimental: Etrolizumab (Open-Label Induction Phase)
    All participants will receive treatment with open-label etrolizumab 105 mg SC injection Q4W up to Week 10.
    Intervention: Drug: Etrolizumab
  • Placebo Comparator: Placebo (Maintenance Phase)
    Participants who achieved a clinical response at Week 10 during induction phase and are randomized to this arm will receive placebo matched to etrolizumab up to Week 62.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2020
Estimated Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic subscore greater than or equal to (>=) 2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore >=1, and a stool frequency subscore >= 1 during the screening period (prior to Day 1)
  • Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4-16 days prior to Day 1
  • Naive to treatment with any anti-TNF therapy
  • Participants must have had an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-aminosalicylate (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
  • 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
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
  • Prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion molecule [MAdCAM-1])
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), or tuberculosis (active or latent)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Czechia,   Denmark,   Germany,   Hungary,   India,   Israel,   Italy,   Mexico,   Poland,   Slovakia,   South Africa,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02165215
Other Study ID Numbers  ICMJE GA29102
2013-004280-31 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2019

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