ANZCTR - Registration

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02394028

Registration number

NCT02394028

Ethics application status

Date submitted

27/02/2015

Date registered

20/03/2015

Date last updated

16/11/2022

Titles & IDs

Public title

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

Scientific title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

Secondary ID [1]

2014-003824-36

Secondary ID [2]

GA29144

Universal Trial Number (UTN)

Trial acronym

BERGAMOT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Crohn Disease

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Inflammatory and Immune System

Other inflammatory or immune system disorders

Oral and Gastrointestinal

Crohn's disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Etrolizumab
Treatment: Drugs - Placebo

Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Placebo comparator: Induction Phase - Cohort 1 (Exploratory): Placebo - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.

Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg - Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg - Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Placebo comparator: Induction Phase - Cohort 3 (Pivotal): Placebo - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.

Placebo comparator: Maintenance Phase - Placebo Responders: Placebo - Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.

Placebo comparator: Maintenance Phase - Etrolizumab Responders: Placebo - Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.

Experimental: Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg - Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.

Treatment: Drugs: Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.

Treatment: Drugs: Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14

Assessment method [1]

Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (=)3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

Timepoint [1]

Week 14

Primary outcome [2]

Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14

Assessment method [2]

Timepoint [2]

Week 14

Primary outcome [3]

Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14

Assessment method [3]

Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.

Timepoint [3]

Week 14

Primary outcome [4]

Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14

Assessment method [4]

Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.

Timepoint [4]

Week 14

Primary outcome [5]

Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66

Assessment method [5]

Timepoint [5]

Baseline and Week 66

Primary outcome [6]

Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66

Assessment method [6]

Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.

Timepoint [6]

Week 66

Secondary outcome [1]

Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6

Assessment method [1]

Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

Timepoint [1]

Week 6

Secondary outcome [2]

Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6

Assessment method [2]

Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

Timepoint [2]

Week 6

Secondary outcome [3]

Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14

Assessment method [3]

Endoscopic Remission is defined as SES-CD total score \<=4 (\<=2 for ileal only patients), with no segment having a subcategory score \>1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.

Timepoint [3]

Week 14

Secondary outcome [4]

Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14

Assessment method [4]

Timepoint [4]

Week 14

Secondary outcome [5]

Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14

Assessment method [5]

CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.

Timepoint [5]

Baseline and Week 14

Secondary outcome [6]

Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14

Assessment method [6]

Timepoint [6]

Baseline and Week 14

Secondary outcome [7]

Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14

Assessment method [7]

Timepoint [7]

Baseline, Weeks 14 and 66

Secondary outcome [8]

Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline

Assessment method [8]

Timepoint [8]

Baseline and Week 66

Secondary outcome [9]

Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14

Assessment method [9]

Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included

Timepoint [9]

Baseline, Weeks 14 and 66

Secondary outcome [10]

Maintenance Phase: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66

Assessment method [10]

Timepoint [10]

Week 66

Secondary outcome [11]

Maintenance Phase: Percentage of Participants With Durable Clinical Remission

Assessment method [11]

Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at =4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included

Timepoint [11]

Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)

Secondary outcome [12]

Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline

Assessment method [12]

Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported. Induction Phase Cohorts are not included

Timepoint [12]

Baseline and from Week 14 up to Week 66

Secondary outcome [13]

Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66

Assessment method [13]

Timepoint [13]

Baseline and Week 66

Secondary outcome [14]

Overall Number of Participants Who Experienced 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)

Assessment method [14]

Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.

Timepoint [14]

From Baseline up to Week 78

Secondary outcome [15]

Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation

Assessment method [15]

Number of participants who discontinued the study due to the adverse events is reported.

Timepoint [15]

From Baseline up to Week 78

Secondary outcome [16]

Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0

Assessment method [16]

Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'

Timepoint [16]

From Baseline up to Week 78

Secondary outcome [17]

Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event

Assessment method [17]

Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once

Timepoint [17]

From Baseline up to Week 78

Secondary outcome [18]

Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0

Assessment method [18]

Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.

Timepoint [18]

From Baseline up to Week 78

Secondary outcome [19]

Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0

Assessment method [19]

Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.

Timepoint [19]

From Baseline up to Week 78

Secondary outcome [20]

Overall Number of Participants Who Develop Malignancies

Assessment method [20]

Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)

Timepoint [20]

From Baseline up to Week 78

Secondary outcome [21]

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

Assessment method [21]

Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose

Timepoint [21]

Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)

Secondary outcome [22]

Observed Trough Serum Concentration (Ctrough) of Etrolizumab

Assessment method [22]

Serum Etrolizumab Trough Concentration

Timepoint [22]

Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66

Eligibility

Key inclusion criteria

* Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
* Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
* Use of effective contraception as defined by the protocol

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
* Planned surgery for CD
* Ileostomy or colostomy
* Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
* Any prior treatment with ustekinumab within 14 weeks prior to randomization
* Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)
* Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
* Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])
* Any major episode of infection requiring treatment with intravenous antibiotics =8 weeks prior to screening or oral antibiotics =4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
* Hospitalization (other than for elective reasons) within 4 weeks prior to randomization

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

20/03/2015

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

7/09/2021

Sample size

Target

Accrual to date

Final

1035

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,VIC,WA

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment hospital [2]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [3]

Concord Repatriation General Hospital - Concord

Recruitment hospital [4]

Royal Brisbane and Women's Hospital - Herston

Recruitment hospital [5]

University of the Sunshine Coast - Sippy Downs

Recruitment hospital [6]

Mater Adult Hospital - South Brisbane

Recruitment hospital [7]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [8]

Flinders Medical Centre - Bedford Park

Recruitment hospital [9]

Monash Medical Centre Clayton - Clayton

Recruitment hospital [10]

St Vincent's Hospital Melbourne - Fitzroy

Recruitment hospital [11]

Footscray Hospital; Gastroenterology - Footscray

Recruitment hospital [12]

St Frances Xavier Cabrini Hospital - Malvern

Recruitment hospital [13]

Alfred Hospital - Melbourne

Recruitment hospital [14]

Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville

Recruitment hospital [15]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

2065 - Garran

Recruitment postcode(s) [2]

2200 - Bankstown

Recruitment postcode(s) [3]

2139 - Concord

Recruitment postcode(s) [4]

4029 - Herston

Recruitment postcode(s) [5]

4556 - Sippy Downs

Recruitment postcode(s) [6]

4101 - South Brisbane

Recruitment postcode(s) [7]

4102 - Woolloongabba

Recruitment postcode(s) [8]

5042 - Bedford Park

Recruitment postcode(s) [9]

3168 - Clayton

Recruitment postcode(s) [10]

3065 - Fitzroy

Recruitment postcode(s) [11]

3011 - Footscray

Recruitment postcode(s) [12]

3144 - Malvern

Recruitment postcode(s) [13]

3004 - Melbourne

Recruitment postcode(s) [14]

3050 - Parkville

Recruitment postcode(s) [15]

6150 - Murdoch

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Colorado

Country [3]

United States of America

State/province [3]

Florida

Country [4]

United States of America

State/province [4]

Georgia

Country [5]

United States of America

State/province [5]

Idaho

Country [6]

United States of America

State/province [6]

Illinois

Country [7]

United States of America

State/province [7]

Kansas

Country [8]

United States of America

State/province [8]

Louisiana

Country [9]

United States of America

State/province [9]

Massachusetts

Country [10]

United States of America

State/province [10]

Michigan

Country [11]

United States of America

State/province [11]

Minnesota

Country [12]

United States of America

State/province [12]

Mississippi

Country [13]

United States of America

State/province [13]

Missouri

Country [14]

United States of America

State/province [14]

New York

Country [15]

United States of America

State/province [15]

North Carolina

Country [16]

United States of America

State/province [16]

Ohio

Country [17]

United States of America

State/province [17]

Oklahoma

Country [18]

United States of America

State/province [18]

Pennsylvania

Country [19]

United States of America

State/province [19]

South Carolina

Country [20]

United States of America

State/province [20]

Tennessee

Country [21]

United States of America

State/province [21]

Texas

Country [22]

United States of America

State/province [22]

Utah

Country [23]

United States of America

State/province [23]

Virginia

Country [24]

United States of America

State/province [24]

Washington

Country [25]

United States of America

State/province [25]

Wisconsin

Country [26]

Argentina

State/province [26]

Buenos Aires

Country [27]

Austria

State/province [27]

Salzburg

Country [28]

Austria

State/province [28]

Wien

Country [29]

Belgium

State/province [29]

Brussels

Country [30]

Belgium

State/province [30]

Brussel

Country [31]

Belgium

State/province [31]

Bruxelles

Country [32]

Belgium

State/province [32]

Edegem

Country [33]

Belgium

State/province [33]

Gent

Country [34]

Brazil

State/province [34]

Country [35]

Brazil

State/province [35]

Country [36]

Brazil

State/province [36]

Country [37]

Brazil

State/province [37]

Country [38]

Brazil

State/province [38]

Country [39]

Brazil

State/province [39]

Country [40]

Brazil

State/province [40]

Country [41]

Bulgaria

State/province [41]

Sofia

Country [42]

Canada

State/province [42]

Alberta

Country [43]

Canada

State/province [43]

British Columbia

Country [44]

Canada

State/province [44]

Manitoba

Country [45]

Canada

State/province [45]

Nova Scotia

Country [46]

Canada

State/province [46]

Ontario

Country [47]

Canada

State/province [47]

Quebec

Country [48]

Canada

State/province [48]

Saskatchewan

Country [49]

Croatia

State/province [49]

Osijek

Country [50]

Croatia

State/province [50]

Pula

Country [51]

Croatia

State/province [51]

Zagreb

Country [52]

Czechia

State/province [52]

Brno

Country [53]

Czechia

State/province [53]

Ceske Budejovice

Country [54]

Czechia

State/province [54]

Hradec Kralove

Country [55]

Czechia

State/province [55]

Olomouc

Country [56]

Czechia

State/province [56]

Ostrava - Poruba

Country [57]

Czechia

State/province [57]

Praha 7

Country [58]

Czechia

State/province [58]

Praha

Country [59]

Estonia

State/province [59]

Tallinn

Country [60]

Estonia

State/province [60]

Tartu

Country [61]

France

State/province [61]

Amiens

Country [62]

France

State/province [62]

Caen

Country [63]

France

State/province [63]

Clichy cedex

Country [64]

France

State/province [64]

Lille

Country [65]

France

State/province [65]

Nantes

Country [66]

France

State/province [66]

Nice

Country [67]

France

State/province [67]

Paris

Country [68]

France

State/province [68]

Pessac

Country [69]

France

State/province [69]

Pierre-Benite

Country [70]

France

State/province [70]

Reims

Country [71]

France

State/province [71]

Rennes cedex 09

Country [72]

France

State/province [72]

Saint Etienne

Country [73]

France

State/province [73]

Strasbourg

Country [74]

France

State/province [74]

Vandoeuvre-les-nancy

Country [75]

Germany

State/province [75]

Berlin

Country [76]

Germany

State/province [76]

Bochum

Country [77]

Germany

State/province [77]

Frankfurt

Country [78]

Germany

State/province [78]

Halle

Country [79]

Germany

State/province [79]

Hannover

Country [80]

Germany

State/province [80]

Koeln

Country [81]

Germany

State/province [81]

Mannheim

Country [82]

Germany

State/province [82]

Offenburg

Country [83]

Germany

State/province [83]

Tuebingen

Country [84]

Germany

State/province [84]

Ulm

Country [85]

Hungary

State/province [85]

Bekescsaba

Country [86]

Hungary

State/province [86]

Budapest

Country [87]

Hungary

State/province [87]

Debrecen

Country [88]

Hungary

State/province [88]

Gyor

Country [89]

Hungary

State/province [89]

Kistarcsa

Country [90]

Hungary

State/province [90]

Pecs

Country [91]

Hungary

State/province [91]

Székesfehérvár

Country [92]

Israel

State/province [92]

Afula

Country [93]

Israel

State/province [93]

Beer Sheva

Country [94]

Israel

State/province [94]

Holon

Country [95]

Israel

State/province [95]

Jerusalem

Country [96]

Israel

State/province [96]

Nazareth

Country [97]

Israel

State/province [97]

Petach Tikva

Country [98]

Israel

State/province [98]

Tel Aviv

Country [99]

Italy

State/province [99]

Emilia-Romagna

Country [100]

Italy

State/province [100]

Lazio

Country [101]

Italy

State/province [101]

Lombardia

Country [102]

Italy

State/province [102]

Piemonte

Country [103]

Italy

State/province [103]

Toscana

Country [104]

Korea, Republic of

State/province [104]

Busan

Country [105]

Korea, Republic of

State/province [105]

Daegu

Country [106]

Korea, Republic of

State/province [106]

Gyeonggi-do

Country [107]

Korea, Republic of

State/province [107]

Seongnam-si

Country [108]

Korea, Republic of

State/province [108]

Seongnam

Country [109]

Korea, Republic of

State/province [109]

Seoul

Country [110]

Korea, Republic of

State/province [110]

Wonju-Si

Country [111]

Latvia

State/province [111]

Riga

Country [112]

Lithuania

State/province [112]

Kaunas

Country [113]

Lithuania

State/province [113]

Vilnius

Country [114]

Mexico

State/province [114]

Mexico CITY (federal District)

Country [115]

Mexico

State/province [115]

Yucatan

Country [116]

Netherlands

State/province [116]

Amsterdam

Country [117]

Netherlands

State/province [117]

Leiden

Country [118]

Netherlands

State/province [118]

Maastricht

Country [119]

Netherlands

State/province [119]

Rotterdam

Country [120]

Netherlands

State/province [120]

Sittard-Geleen

Country [121]

Netherlands

State/province [121]

Tilburg

Country [122]

New Zealand

State/province [122]

Auckland

Country [123]

New Zealand

State/province [123]

Christchurch

Country [124]

New Zealand

State/province [124]

Dunedin

Country [125]

New Zealand

State/province [125]

Hamilton

Country [126]

New Zealand

State/province [126]

Takapuna

Country [127]

New Zealand

State/province [127]

Tauranga

Country [128]

Poland

State/province [128]

Bialystok

Country [129]

Poland

State/province [129]

Bydgoszcz

Country [130]

Poland

State/province [130]

Elblag

Country [131]

Poland

State/province [131]

Kielce

Country [132]

Poland

State/province [132]

Ksawerow

Country [133]

Poland

State/province [133]

Lublin

Country [134]

Poland

State/province [134]

Nowy Targ

Country [135]

Poland

State/province [135]

Rzeszow

Country [136]

Poland

State/province [136]

Rzeszów

Country [137]

Poland

State/province [137]

Sopot

Country [138]

Poland

State/province [138]

Szczecin

Country [139]

Poland

State/province [139]

Torun

Country [140]

Poland

State/province [140]

Warszawa

Country [141]

Poland

State/province [141]

Wroclaw

Country [142]

Romania

State/province [142]

Bucharest

Country [143]

Romania

State/province [143]

Bucuresti

Country [144]

Romania

State/province [144]

Timisoara

Country [145]

Russian Federation

State/province [145]

Adygeja

Country [146]

Russian Federation

State/province [146]

Altaj

Country [147]

Russian Federation

State/province [147]

Leningrad

Country [148]

Russian Federation

State/province [148]

Sankt Petersburg

Country [149]

Russian Federation

State/province [149]

Barnaul

Country [150]

Russian Federation

State/province [150]

Irkutsk

Country [151]

Russian Federation

State/province [151]

Novosibirsk

Country [152]

Russian Federation

State/province [152]

Omsk

Country [153]

Russian Federation

State/province [153]

Pushkin

Country [154]

Russian Federation

State/province [154]

Rostov-on-Don

Country [155]

Russian Federation

State/province [155]

St. Petersburg

Country [156]

Serbia

State/province [156]

Belgrade

Country [157]

Serbia

State/province [157]

Novi Sad

Country [158]

Serbia

State/province [158]

Zrenjanin

Country [159]

Slovakia

State/province [159]

Bratislava

Country [160]

Slovakia

State/province [160]

Nitra

Country [161]

Slovakia

State/province [161]

Vranov nad Toplou

Country [162]

Slovakia

State/province [162]

Šahy

Country [163]

South Africa

State/province [163]

Cape Town

Country [164]

South Africa

State/province [164]

Pretoria

Country [165]

Spain

State/province [165]

Barcelona

Country [166]

Spain

State/province [166]

Madrid

Country [167]

Spain

State/province [167]

Cordoba

Country [168]

Spain

State/province [168]

Huelva

Country [169]

Spain

State/province [169]

Pontevedra

Country [170]

Spain

State/province [170]

Sevilla

Country [171]

Spain

State/province [171]

Valencia

Country [172]

Spain

State/province [172]

Zaragoza

Country [173]

Switzerland

State/province [173]

Bern

Country [174]

Switzerland

State/province [174]

Zürich

Country [175]

Turkey

State/province [175]

Ankara

Country [176]

Turkey

State/province [176]

Istanbul

Country [177]

Turkey

State/province [177]

Izmir

Country [178]

Turkey

State/province [178]

Kocaeli

Country [179]

Turkey

State/province [179]

Kozyatagi

Country [180]

Ukraine

State/province [180]

Kharkiv Governorate

Country [181]

Ukraine

State/province [181]

KIEV Governorate

Country [182]

Ukraine

State/province [182]

Kuban People's Republica

Country [183]

Ukraine

State/province [183]

Podolia Governorate

Country [184]

Ukraine

State/province [184]

Poltava Governorate

Country [185]

Ukraine

State/province [185]

Tavria Okruha

Country [186]

Ukraine

State/province [186]

Kharkiv

Country [187]

Ukraine

State/province [187]

Kyiv

Country [188]

Ukraine

State/province [188]

Mykolaiv

Country [189]

Ukraine

State/province [189]

Odesa

Country [190]

Ukraine

State/province [190]

Vinnytsia

Country [191]

Ukraine

State/province [191]

Zaporizhzhia

Country [192]

United Kingdom

State/province [192]

Belfast

Country [193]

United Kingdom

State/province [193]

Cambridge

Country [194]

United Kingdom

State/province [194]

Coventry

Country [195]

United Kingdom

State/province [195]

Exeter

Country [196]

United Kingdom

State/province [196]

Kings Lynn

Country [197]

United Kingdom

State/province [197]

Leeds

Country [198]

United Kingdom

State/province [198]

Liverpool

Country [199]

United Kingdom

State/province [199]

London

Country [200]

United Kingdom

State/province [200]

Manchester

Country [201]

United Kingdom

State/province [201]

Newcastle Upon Tyne

Country [202]

United Kingdom

State/province [202]

Nottingham

Country [203]

United Kingdom

State/province [203]

Reading

Country [204]

United Kingdom

State/province [204]

Southampton

Country [205]

United Kingdom

State/province [205]

Wolverhampton

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Hoffmann-La Roche

Country

Ethics approval

Ethics application status

Summary

Brief summary

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Trial website

https://clinicaltrials.gov/study/NCT02394028

Trial related presentations / publications

Sandborn WJ, Panes J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baia C, Atreya R, Panaccione R, Rydzewska G, Aguilar H, Vermeire S; BERGAMOT Study Group. Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):43-55. doi: 10.1016/S2468-1253(22)00303-X. Epub 2022 Oct 12.
Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through alpha4beta7 and alphaEbeta7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17.
Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

Public notes

Contacts

Principal investigator

Name

Clinical Trials

Address

Hoffmann-La Roche

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol
Statistical analysis plan

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02394028

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02394028