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Monoclonal Antibodies

Etrolizumab for Ulcerative Colitis (COTTONWOOD Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 9 years (assessed at baseline, week 4, 8, 12 thereafter every 12 weeks up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Awards & highlights

COTTONWOOD Trial Summary

This trial will study the efficacy and safety of etrolizumab as a treatment for moderate to severe ulcerative colitis. The trial will last for up to 9 years and will enroll participants who have completed the 12-week safety follow-up period from the Phase II OLE study or the Phase III studies.

Eligible Conditions
  • Ulcerative Colitis

COTTONWOOD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the sponsor's decision to terminate the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the sponsor's decision to terminate the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in pMCS at Year 9
Percentage of Participants With Adverse Events - Part 1
Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1
+4 more

COTTONWOOD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Part 1: Open-label ExtensionExperimental Treatment1 Intervention
Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).
Group II: Part 2: Safety MonitoringActive Control1 Intervention
All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrolizumab
2015
Completed Phase 3
~2840

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,087,310 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,944 Patients Enrolled for Ulcerative Colitis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
886,738 Total Patients Enrolled
11 Trials studying Ulcerative Colitis
2,368 Patients Enrolled for Ulcerative Colitis

Media Library

Etrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02118584 — Phase 3
Ulcerative Colitis Research Study Groups: Part 1: Open-label Extension, Part 2: Safety Monitoring
Ulcerative Colitis Clinical Trial 2023: Etrolizumab Highlights & Side Effects. Trial Name: NCT02118584 — Phase 3
Etrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02118584 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this study at most?

"This trial is no longer active. The study was first made public on September 15th, 2014 and the last update was on September 29th, 2022. For those still searching for trials to participate in, there are presently 424 clinical trials actively looking for patients with colitis, ulcerative and 3 studies for Etrolizumab actively searching for patients."

Answered by AI

Has the United States Food and Drug Administration cleared Etrolizumab for patient use?

"There is some evidence supporting the efficacy of etrolizumab, as this is a phase 3 trial. Furthermore, there have been multiple rounds of data that support its safety; thus, it receives a score of 3."

Answered by AI

Is this study taking place in several hospitals across North America?

"73 patients have already been recruited for this clinical trial, which is being conducted at Great Lakes Gastroenterology Research, LLC in Mentor, SDG Clinical Research in San Diego, University of California, Irvine Medical Center in Orange, and other locations."

Answered by AI

Do we have room for more participants in this trial?

"No, this particular trial is not enrolling patients at the moment according to the information available on clinicaltrials.gov. Although the last update was on September 29th, 2022, this study was first posted almost 8 years ago on September 15th, 2014. There are however 427 other trials that are still looking for participants."

Answered by AI

Does this research stand alone or has there been previous investigation into Etrolizumab?

"Currently, there are three different clinical trials underway that are studying etrolizumab. Out of those three, two are in phase 3. Most of the research regarding etrolizumab is taking place in Kozyataği, New jersey; however, 1045 other sites across the globe are also running similar investigations."

Answered by AI

Is this an original study?

"Eight clinical trials have been completed for Etrolizumab since its initial Phase 3 drug approval in 2014. Presently, there are three ongoing studies being conducted across 253 cities and 44 countries."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
IMIC, Inc
Internal Medicine Specialists
What portion of applicants met pre-screening criteria?
Met criteria
~174 spots leftby Mar 2025