An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003855-76-SE

Enrollment

1250

Registered

2015-01-27

Start date

2015-08-12

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn`s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Part 1 Open-label Extension: -Patients previously enrolled in etrolizumab Phase III study GA29144 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Part 1 Open-label Extension: -Any new, significant, uncontrolled condition Part 2 Safety Monitoring: -No exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of this open-label extension-safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety Monitoring; SM) • Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment Safety Objectives The other safety objectives for this study are as follows: Part 1 (OLE) • To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events • To evaluate the incidence and rate per subject-year of malignancies • To evaluate the incidence and severity of hypersensitivity reactions • To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs);Secondary Objective: Not applicable;Primary end point(s): The efficacy outcome measures: • CDAI remission assessed at 12-week intervals during Part 1 (OLE) • PRO2 remission assessed at 12-week intervals during Part 1 (OLE) • Simplified Endoscopic Index for Crohn's disease (SES-CD) score assessed at Week 108 or at early withdrawal, if prior to Week 108, during Part 1 (OLE) Safety Outcome Measures Part 1 (OLE) • Incidence and severity of adverse events • Incidence of serious adverse events • Incidence, rate per subject-year, and severity of infection-related adverse events • Incidence of serious infection-related adverse events • Incidence and severity of injection-site reactions • Incidence of adverse events leading to etrolizumab discontinuation • Incidence of laboratory abnormalities • Incidence and rate per subject-year of malignancies • Incidence of ATAs to etrolizumab • Incidence and severity of hypersensitivity reaction events Part 2 (SM) • Incidence of suspected or confirmed PML events;Timepoint(s) of evaluation of this end point: • CDAI remission assessed at 12-week • PRO2 remission assessed at 12-week The CDAI and PRO2 scores will be calculated, and th	—

Measure

Time frame

Main Objective: The objectives of this open-label extension-safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety Monitoring; SM) • Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment Safety Objectives The other safety objectives for this study are as follows: Part 1 (OLE) • To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events • To evaluate the incidence and rate per subject-year of malignancies • To evaluate the incidence and severity of hypersensitivity reactions • To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs);Secondary Objective: Not applicable;Primary end point(s): The efficacy outcome measures: • CDAI remission assessed at 12-week intervals during Part 1 (OLE) • PRO2 remission assessed at 12-week intervals during Part 1 (OLE) • Simplified Endoscopic Index for Crohn's disease (SES-CD) score assessed at Week 108 or at early withdrawal, if prior to Week 108, during Part 1 (OLE) Safety Outcome Measures Part 1 (OLE) • Incidence and severity of adverse events • Incidence of serious adverse events • Incidence, rate per subject-year, and severity of infection-related adverse events • Incidence of serious infection-related adverse events • Incidence and severity of injection-site reactions • Incidence of adverse events leading to etrolizumab discontinuation • Incidence of laboratory abnormalities • Incidence and rate per subject-year of malignancies • Incidence of ATAs to etrolizumab • Incidence and severity of hypersensitivity reaction events Part 2 (SM) • Incidence of suspected or confirmed PML events;Timepoint(s) of evaluation of this end point: • CDAI remission assessed at 12-week • PRO2 remission assessed at 12-week The CDAI and PRO2 scores will be calculated, and th

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026