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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
2/12/2024

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 at 12-week Intervals
Timepoint [1] 0 0
Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
Primary outcome [2] 0 0
Part 1: Number of Participants With Clinical Remission at 12-week Intervals
Timepoint [2] 0 0
Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
Primary outcome [3] 0 0
Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
Timepoint [3] 0 0
At OLE Week 108
Primary outcome [4] 0 0
Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Timepoint [4] 0 0
From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years)
Primary outcome [5] 0 0
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [6] 0 0
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
Timepoint [6] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [7] 0 0
Part 1: Incidence Rate of Infection-related Adverse Event
Timepoint [7] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [8] 0 0
Part 1: Number of Participants With Serious Infection Related AES
Timepoint [8] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [9] 0 0
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
Timepoint [9] 0 0
From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years)
Primary outcome [10] 0 0
Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation
Timepoint [10] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [11] 0 0
Part 1: Number of Participants With Malignancies
Timepoint [11] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [12] 0 0
Part 1: Incidence Rate of Malignancies
Timepoint [12] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [13] 0 0
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
Timepoint [13] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
Primary outcome [14] 0 0
Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML)
Timepoint [14] 0 0
From end of safety follow-up in Part 1 or study GA29144 up to maximum of 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
Accrual to date
Final
790
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
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United States of America
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Colorado
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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
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/NCT02403323