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Monoclonal Antibodies

Etrolizumab for Crohn's Disease (JUNIPER 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 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)

Awards & highlights

JUNIPER Trial Summary

This trial is studying the long-term safety and efficacy of etrolizumab in treating Crohn's disease. Two parts will evaluate different aspects of the treatment: Part 1 will look at continued treatment in patients who were previously enrolled in a Phase III study, and Part 2 will monitor patients who have stopped treatment for any safety events.

JUNIPER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Infection-Related Adverse Events per Patient-Year

Part 1: Number of Malignancies per Patient-Year

Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

+11 more

JUNIPER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Part 1: Etrolizumab Open-Label ExtensionExperimental Treatment1 Intervention

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).

Group II: Part 2: Safety MonitoringActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Etrolizumab

2015

Completed Phase 3

~2840

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,154 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,602 Total Patients Enrolled

Media Library

Etrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02403323 — Phase 3

Crohn's Disease Research Study Groups: Part 2: Safety Monitoring, Part 1: Etrolizumab Open-Label Extension

Crohn's Disease Clinical Trial 2023: Etrolizumab Highlights & Side Effects. Trial Name: NCT02403323 — Phase 3

Etrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02403323 — Phase 3

Frequently Asked Questions

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

What other drugs has Etrolizumab been tested with in the past?

"3 clinical trials investigating Etrolizumab are ongoing, 2 of which are in Phase 3. A majority of the research sites for these studies are located in Kozyataği, New jersey; however, there are 1045 total locations where these studies are taking place."

Answered by AI

Have other researchers looked into this topic before?

"There have been a total of 3 clinical trials for Etrolizumab over the course of 7 years. The first study began in 2014 and completed its final stage of drug approval in Phase 3. This initial trial, sponsored by Hoffmann-La Roche, included 1822 participants. In the years since 2014, 8 more studies have been conducted across 44 countries and 253 cities."

Answered by AI

How many people will be given the opportunity to try this new treatment?

"As of now, this study is not looking for any more patients. However, it's important to note that the trial was posted on 6/8/2015 and was most recently edited on 11/11/2022. Additionally, if you are interested in other studies, there are currently 258 clinical trials actively looking for participants with ileocolitis and 3 studies for Etrolizumab actively looking for participants."

Answered by AI

Are patients still being sought for this clinical trial?

"This study has wrapped up recruiting patients. It was first posted on 6/8/2015, and the most recent update was 11/11/2022. However, there are other ongoing clinical trials that may be of interest. There are 258 studies actively recruiting patients with ileocolitis and 3 studies for Etrolizumab that still need participants."

Answered by AI