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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02100696




Registration number
NCT02100696
Ethics application status
Date submitted
27/03/2014
Date registered
1/04/2014
Date last updated
13/08/2021

Titles & IDs
Public title
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Scientific 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
Secondary ID [1] 0 0
2013-004278-88
Secondary ID [2] 0 0
GA28950
Universal Trial Number (UTN)
Trial acronym
HICKORY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrozulimab
Treatment: Drugs - Placebo

Experimental: Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase) - Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.

Placebo comparator: Cohort 2: Placebo (Double-Blind Induction Phase) - Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.

Experimental: Cohort 2: Etrolizumab (Double-Blind Induction Phase) - Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.

Placebo comparator: Placebo Responders: Placebo (Maintenance Phase) - Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.

Placebo comparator: Etrolizumab Responders: Placebo (Maintenance Phase) - Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.

Experimental: Etrolizumab Responders: Etrolizumab (Maintenance Phase) - Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.


Treatment: Drugs: Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

Treatment: Drugs: Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)
Timepoint [1] 0 0
Week 14
Primary outcome [2] 0 0
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS
Timepoint [2] 0 0
Week 66
Secondary outcome [1] 0 0
Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
Induction Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore
Timepoint [3] 0 0
Baseline and Week 14
Secondary outcome [4] 0 0
Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore
Timepoint [6] 0 0
Baseline and Week 6
Secondary outcome [7] 0 0
Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore
Timepoint [7] 0 0
Baseline and Week 6
Secondary outcome [8] 0 0
Induction Phase: Change From Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire
Timepoint [8] 0 0
Baseline and Week 14
Secondary outcome [9] 0 0
Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [9] 0 0
Baseline and Week 14
Secondary outcome [10] 0 0
Induction Phase: Change From Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [10] 0 0
Baseline and Week 14
Secondary outcome [11] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS
Timepoint [11] 0 0
Week 66
Secondary outcome [12] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS
Timepoint [12] 0 0
Week 66
Secondary outcome [13] 0 0
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS
Timepoint [13] 0 0
Week 66
Secondary outcome [14] 0 0
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore
Timepoint [14] 0 0
Baseline and Week 66
Secondary outcome [15] 0 0
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index
Timepoint [15] 0 0
Week 66
Secondary outcome [16] 0 0
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore
Timepoint [16] 0 0
Week 66
Secondary outcome [17] 0 0
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
Timepoint [17] 0 0
Week 66
Secondary outcome [18] 0 0
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
Timepoint [18] 0 0
Week 66
Secondary outcome [19] 0 0
Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [19] 0 0
Baseline and Week 66
Secondary outcome [20] 0 0
Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [20] 0 0
Baseline and Week 66
Secondary outcome [21] 0 0
Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ
Timepoint [21] 0 0
Baseline and Week 66
Secondary outcome [22] 0 0
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Timepoint [22] 0 0
From Baseline up to Week 78
Secondary outcome [23] 0 0
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Timepoint [23] 0 0
From Baseline up to Week 78
Secondary outcome [24] 0 0
Number of Participants With Serious Infection-Related Adverse Events
Timepoint [24] 0 0
From Baseline up to Week 78
Secondary outcome [25] 0 0
Number of Participants With Infection-Related Adverse Events
Timepoint [25] 0 0
From Baseline up to Week 78
Secondary outcome [26] 0 0
Number of Participants With Injection-Site Reaction-Related Adverse Events
Timepoint [26] 0 0
From Baseline up to Week 78
Secondary outcome [27] 0 0
Number of Participants With Hypersensitivity Reaction-Related Adverse Events
Timepoint [27] 0 0
From Baseline up to Week 78
Secondary outcome [28] 0 0
Number of Participants With Malignancies
Timepoint [28] 0 0
From Baseline up to Week 78
Secondary outcome [29] 0 0
Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study
Timepoint [29] 0 0
Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78)
Secondary outcome [30] 0 0
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
Timepoint [30] 0 0
Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66
Secondary outcome [31] 0 0
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
Timepoint [31] 0 0
Weeks 44 and 66

Eligibility
Key inclusion criteria
* Diagnosis of UC established at least 3 months prior to Day 1
* Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
* Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
* Any prior treatment with rituximab
* 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 or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
* Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
* History of recurrent opportunistic infections and/or severe disseminated viral infections
* History of 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/04/2020
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Launceston General Hospital; Gastroenterology Research - Launceston
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Footscray Hospital; Gastroenterology - Footscray
Recruitment hospital [7] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
7250 - Launceston
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
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Illinois
Country [7] 0 0
United States of America
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Kansas
Country [8] 0 0
United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Rosario
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Austria
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Klagenfurt
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Bonheiden
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Brussels
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Belgium
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Brussel
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Belgium
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Gent
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Belgium
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Herentals
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Belgium
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Leuven
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Belgium
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Liège
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Roeselare
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GO
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Brno
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Hradec Kralove
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Czechia
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Pardubice
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Czechia
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Prague
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Praha 7
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Czechia
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Usti Nad Labem
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København Ø
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Ålborg
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Clichy cedex
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Lille
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Marseille cedex 20
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Toulouse Cedex 09
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Vandoeuvre-les-nancy
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Erlangen
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Frankfurt
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Freiburg
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Halle
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Hamburg
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Hannover
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Kiel
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Mannheim
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Muenster
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Ulm
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Thessaloniki
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Eger
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Gyor
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Gyeonggi-do
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Seoul
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Suwon-si,
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Mexico
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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NL -nijmegen
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Poland
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Bydgoszcz
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Katowice
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Rzeszów
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Szczecin
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Warszawa
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Wroclaw
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Romania
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Bucuresti
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Madrid
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Spain
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Girona
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Valencia
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Spain
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Zaragoza
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Switzerland
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Bern
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Cambridge
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United Kingdom
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Exeter
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London
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Manchester
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Newcastle upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02100696