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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 : Recruiting
First Posted : April 1, 2014
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrozulimab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2014
Estimated Primary Completion Date : December 26, 2020
Estimated Study Completion Date : December 26, 2020

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Etrozulimab
Participants will receive 105 mg administered by subcutaneous injection every 4 weeks.
Other Name: PRO145223, RO549026
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.
 Drug: Etrozulimab
Participants will receive 105 mg administered by subcutaneous injection every 4 weeks.
Other Name: PRO145223, RO549026
Placebo Comparator: Cohort 2: Placebo (Double-blind Induction Phase)
All participants will receive treatment with placebo matched with etrolizumab.
 Drug: Placebo
Participants will receive placebo matched with etrolizumab.
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.
 Drug: Etrozulimab
Participants will receive 105 mg administered by subcutaneous injection every 4 weeks.
Other Name: PRO145223, RO549026
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.
 Drug: Placebo
Participants will receive placebo matched with etrolizumab.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 14 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of Participants With Clinical Response at Week 14 (Induction Phase) and Week 66 (Maintenance Phase) [ Time Frame: Week 14, 66 ]
  3. 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 ]
  4. Percentage of Participants With Endoscopic Remission at Week 14 (Induction Phase) and Week 66 (Maintenance Phase) [ Time Frame: Week 14, 66 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants who Were Receiving Corticosteroids at Baseline [ Time Frame: Week 66 ]
  9. Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants who Were Receiving Corticosteroids at Baseline [ Time Frame: Week 66 ]
  10. Area Under the Serum Concentration-Time Curve (AUC) [ Time Frame: pre-dose (0 hours), post-dose on Week 14, 24, 44, 66 ]
  11. Maximum Observed Serum Concentration (Cmax) [ Time Frame: pre-dose (0 hours), post-dose on Week 14, 24, 44, 66 ]
  12. Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) [ Time Frame: pre-dose on Week 14, 24, 44, 66 ]
  13. Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab [ Time Frame: Baseline up to Week 66 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100696


Contacts
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

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02100696     History of Changes
Other Study ID Numbers: GA28950
2013-004278-88 ( EudraCT Number )
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases