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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

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ClinicalTrials.gov Identifier: NCT02100696
Recruitment Status : Active, not recruiting
First Posted : April 1, 2014
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 27, 2014
First Posted Date  ICMJE April 1, 2014
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE May 21, 2014
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • 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 ]
Change History Complete list of historical versions of study NCT02100696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Clinical remission as determined by MCS [ Time Frame: At Weeks 14 and 66 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Official Title  ICMJE 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
Brief Summary 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 have been previously exposed to TNF inhibitors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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.
Study Arms
  • 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
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: March 27, 2014)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 26, 2020
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • 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
  • Treatment within 5 years prior to screening with one or two induction regimines that contain TNF inhibitors (including TNF inhibitor biosimilars)

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
  • Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   Poland,   Romania,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Czech Republic,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT02100696
Other Study ID Numbers  ICMJE GA28950
2013-004278-88 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement 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