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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02403323




Registration number
NCT02403323
Ethics application status
Date submitted
26/03/2015
Date registered
31/03/2015
Date last updated
1/11/2023

Titles & IDs
Public title
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Scientific title
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Secondary ID [1] 0 0
2014-003855-76
Secondary ID [2] 0 0
GA29145
Universal Trial Number (UTN)
Trial acronym
JUNIPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

Experimental: Part 1: Etrolizumab Open-Label Extension - Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled).

No intervention: Part 2: Safety Monitoring - Participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.


Treatment: Drugs: Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time
Timepoint [1] 0 0
Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [2] 0 0
Part 1: Number of Participants with Clinical Remission Over Time
Timepoint [2] 0 0
Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earlier (up to approximately 10 years)
Primary outcome [3] 0 0
Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
Timepoint [3] 0 0
Week 108 (or at early withdrawal, if prior to Week 108)
Primary outcome [4] 0 0
Part 1: 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)
Timepoint [4] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [5] 0 0
Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation
Timepoint [5] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [6] 0 0
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Timepoint [6] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [7] 0 0
Part 1: Number of Infection-Related Adverse Events per Patient-Year
Timepoint [7] 0 0
From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [8] 0 0
Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event
Timepoint [8] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [9] 0 0
Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Timepoint [9] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [10] 0 0
Part 1: Overall Number of Participants who Develop Malignancies
Timepoint [10] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [11] 0 0
Part 1: Number of Malignancies per Patient-Year
Timepoint [11] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [12] 0 0
Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Timepoint [12] 0 0
From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary outcome [13] 0 0
Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Timepoint [13] 0 0
Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years)
Primary outcome [14] 0 0
Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML)
Timepoint [14] 0 0
From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks)

Eligibility
Key inclusion criteria
Part 1 Open-Label Extension:

* Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

* Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
* Patients who transfer from Part 1
* Completion of the 12-week safety follow-up period prior to entering
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1 Open-Label Extension:

* Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

* No exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/10/2023
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [5] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Footscray Hospital - Footscray
Recruitment hospital [10] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
Recruitment hospital [12] 0 0
The Alfred Hospital - Prahan
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3011 - Footscray
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
3181 - Prahan
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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Kharkiv
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Liverpool
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Manchester
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Nottingham
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Reading
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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
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Trial website
https://clinicaltrials.gov/study/NCT02403323
Trial related presentations / publications
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
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Hoffmann-La Roche
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02403323