An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004435-72-DE

Enrollment

2100

Registered

2014-07-18

Start date

2015-02-06

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Part 1 (Open-label Extension) - Patients previously enrolled in Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol Part 2 (Safety Monitoring) - Patients who participated in one of the etrolizumab Phase II OLE study or Phase III studies and are not eligible or chose not to enter Part 1 (OLE) - Patients who transfer from Part 1 (OLE) - Completion of the 12-week safety follow-up 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 1907 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 193

Exclusion criteria

Exclusion criteria: Part 1 (Open-label Extension) - Any new, significant, uncontrolled condition - Receipt of the following since commencement of the Phase II OLE or Phase III controlled studies: Use of anti-adhesion molecules Part 2 (Safety Monitoring) - No exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: • Part 1 (OLE): to assess the long-term safety and efficacy of etrolizumab in eligible patients. • Part 2 (SM): Progressive multifocal leukoencephalopathy (PML) safety monitoring. ;Secondary Objective: n.a.;Primary end point(s): 1) Long-term efficacy as determined by partial Mayo Clinic Score (pMCS) 2) To evaluate remission by MCS at Week 108 in Part 1 (OLE) 3) To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE) 4) Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1 and 4: Up to 7 years 2 and 3: at Week 108 in Part 1 (OLE)	—

Measure

Time frame

Main Objective: • Part 1 (OLE): to assess the long-term safety and efficacy of etrolizumab in eligible patients. • Part 2 (SM): Progressive multifocal leukoencephalopathy (PML) safety monitoring. ;Secondary Objective: n.a.;Primary end point(s): 1) Long-term efficacy as determined by partial Mayo Clinic Score (pMCS) 2) To evaluate remission by MCS at Week 108 in Part 1 (OLE) 3) To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE) 4) Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1 and 4: Up to 7 years 2 and 3: at Week 108 in Part 1 (OLE)

—

Secondary

Measure	Time frame
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States, Viet Nam

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