Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (JUNIPER)

• ClinicalTrials.gov Identifier: NCT02403323
• Recruitment Status: Active, not recruiting
• First Posted: March 31, 2015
• Last Update Posted: May 6, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: March 26, 2015
• First Posted Date: March 31, 2015
• Last Update Posted Date: May 6, 2023
• Actual Study Start Date: June 8, 2015
• Estimated Primary Completion Date: May 21, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 25, 2019)

• Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time [ Time Frame: 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) ]
• Part 1: Number of Participants with Clinical Remission Over Time [ Time Frame: 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) ]
  Clinical remission is defined by a loose/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain mean daily score ≤1 with no worsening in either subscore compared to baseline, averaged over 7 days prior to visit.
• Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 [ Time Frame: Week 108 (or at early withdrawal, if prior to Week 108) ]
• 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) [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Number of Infection-Related Adverse Events per Patient-Year [ Time Frame: From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants who Develop Malignancies [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Number of Malignancies per Patient-Year [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
• Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years) ]
• Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML) [ Time Frame: From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks) ]

• Original Primary Outcome Measures (submitted: March 26, 2015): Open-label Extension Safety: Incidence of adverse events [ Time Frame: For up to 6.5 years after the first patient is enrolled into the study ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn Disease

Intervention

Drug: Etrolizumab

105 mg etrolizumab subcutaneous administration once every 4 weeks

Other Name: RG7413

Study Arms

• 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).
  Intervention: Drug: Etrolizumab
• 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.

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 1, 2015): 900
• Original Estimated Enrollment (submitted: March 26, 2015): 1250
• Estimated Study Completion Date: May 21, 2026
• Estimated Primary Completion Date: May 21, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Exclusion Criteria:

Part 1 Open-Label Extension:

• Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

• No exclusion criteria

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic, Luxembourg, Sweden

Administrative Information

• NCT Number: NCT02403323
• Other Study ID Numbers: GA29145; 2014-003855-76 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Same as current
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: May 2023