A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to 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 HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004278-88-CZ

Enrollment

605

Registered

2014-06-09

Start date

2014-07-09

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETROLIZUM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars) - 18-80 years of age, inclusive - Diagnosis of UC established at least 3 months prior to Day 1 - Moderately to severely active UC as determined by the MCS - Washout of TNF inhibitor 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 - Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 575 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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 - Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol - Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1) - 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 within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1 - History of recurrent opportunistic infections, severe disseminated viral infections and 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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1) at week 14 2) at week 66 ; Primary end point(s): 1) Remission at W 14, as determined by the Mayo Clinic Score (MCS) 2) Remission at W 66 among patients with a clinical response at W 14 as determined by MCS ; Main Objective: • To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the Mayo Clinic Score (MCS) at Week (W) 14. • To evaluate the efficacy of etrolizumab (105 mg SC Q4W) compared with placebo for remission at W66 among patients with a clinical response at W14, as determined by the MCS ; Secondary Objective: • Clinical remission at W14 and W66 • Clinical response at W14 • Improvement in endoscopic appearance of the mucosa at W14 and W66 • Endoscopic and histologic remission at W14 and W66 • Change from baseline (BL) in rectal bleed and stool frequency subscore at W6 • Change from BL in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by Ulcerative Colitis Patient Reported Outcome Signs and Symptoms (UC-PRO/SS) • Change from BL in Patient Reported health related Quality of Life at W14 and W66, as assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) • Clinical remission at W66 in patients in clinical remission at W14 • Remission at W66 among patients in remission at W14 • Corticosteroid (CS)-free clinical remission and remission at W66 in patients receiving CSs at BL • Etrolizumab Serum Concentration • Percentage of participants with Adverse Events • Percentage of participants with Anti-Therapeutic Antibodies to Etrolizumab	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1) at week 14 2) at week 66 ; Primary end point(s): 1) Remission at W 14, as determined by the Mayo Clinic Score (MCS) 2) Remission at W 66 among patients with a clinical response at W 14 as determined by MCS ; Main Objective: • To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the Mayo Clinic Score (MCS) at Week (W) 14. • To evaluate the efficacy of etrolizumab (105 mg SC Q4W) compared with placebo for remission at W66 among patients with a clinical response at W14, as determined by the MCS ; Secondary Objective: • Clinical remission at W14 and W66 • Clinical response at W14 • Improvement in endoscopic appearance of the mucosa at W14 and W66 • Endoscopic and histologic remission at W14 and W66 • Change from baseline (BL) in rectal bleed and stool frequency subscore at W6 • Change from BL in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by Ulcerative Colitis Patient Reported Outcome Signs and Symptoms (UC-PRO/SS) • Change from BL in Patient Reported health related Quality of Life at W14 and W66, as assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) • Clinical remission at W66 in patients in clinical remission at W14 • Remission at W66 among patients in remission at W14 • Corticosteroid (CS)-free clinical remission and remission at W66 in patients receiving CSs at BL • Etrolizumab Serum Concentration • Percentage of participants with Adverse Events • Percentage of participants with Anti-Therapeutic Antibodies to Etrolizumab

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Secondary

Measure	Time frame
Secondary end point(s): Percentage of participants in/with 1. Clinical remission at W14 and W66, as determined by MCS 2. Clinical response at W14, as determined by MCS 3. Improvement in endoscopic appearance of the mucosa at W14 and W66, as determined by Mayo Endoscopic Subscore 4. Endoscopic and histologic remission at W14 and W66, as determined by Mayo Endoscopic Subscore and Nancy Histological Index (NHI) respectively 5. Change from baseline in rectal bleed and stool frequency subscore at W6, as determined by Mayo rectal bleeding and stool frequency Subscores respectively 6. Change from baseline in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by UC-PRO/SS 7. Change from baseline in health-related Quality of Life at W14 and W66, as assessed by IBDQ 8. Clinical remission at W66 among patients in clinical remission at W14, as determined by MCS 9. Remission at W66 among patients in remission at W14, as determined by MCS 10. Corticosteroid (CS)- free clinical remission and remission at W66 in patients who were receiving CSs at baseline, as determined by MCS 11. Etrolizumab Serum Concentration 12. Adverse Events 13. Anti-Therapeutic Antibodies to Etrolizumab ; Timepoint(s) of evaluation of this end point: 1. W14, W66 2. W14 3-4. W14, W66 5. Baseline (Day-35- Day-1), W6 6-7. Baseline, W14, W66 8-9. W14 and W66 10. W66 11. Pre-dose (0 hour) on Day 1, Post-dose W14, W24, W44, W66, early termination/end of safety follow-up (up to W78) 12. Baseline up to end of study (up to W78) 13. Pre-dose (0 hour) on Day 1, Post-dose W4, W14, W24, W44, W66, early terminati	—

Measure

Time frame

Secondary end point(s): Percentage of participants in/with 1. Clinical remission at W14 and W66, as determined by MCS 2. Clinical response at W14, as determined by MCS 3. Improvement in endoscopic appearance of the mucosa at W14 and W66, as determined by Mayo Endoscopic Subscore 4. Endoscopic and histologic remission at W14 and W66, as determined by Mayo Endoscopic Subscore and Nancy Histological Index (NHI) respectively 5. Change from baseline in rectal bleed and stool frequency subscore at W6, as determined by Mayo rectal bleeding and stool frequency Subscores respectively 6. Change from baseline in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by UC-PRO/SS 7. Change from baseline in health-related Quality of Life at W14 and W66, as assessed by IBDQ 8. Clinical remission at W66 among patients in clinical remission at W14, as determined by MCS 9. Remission at W66 among patients in remission at W14, as determined by MCS 10. Corticosteroid (CS)- free clinical remission and remission at W66 in patients who were receiving CSs at baseline, as determined by MCS 11. Etrolizumab Serum Concentration 12. Adverse Events 13. Anti-Therapeutic Antibodies to Etrolizumab ; Timepoint(s) of evaluation of this end point: 1. W14, W66 2. W14 3-4. W14, W66 5. Baseline (Day-35- Day-1), W6 6-7. Baseline, W14, W66 8-9. W14 and W66 10. W66 11. Pre-dose (0 hour) on Day 1, Post-dose W14, W24, W44, W66, early termination/end of safety follow-up (up to W78) 12. Baseline up to end of study (up to W78) 13. Pre-dose (0 hour) on Day 1, Post-dose W4, W14, W24, W44, W66, early terminati

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Romania, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026