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Monoclonal Antibodies

Vixarelimab Dose Regimen 1 for Ulcerative Colitis

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of UC for at least 3 months
Moderately to severely active UC, assessed by mMS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 56
Awards & highlights

Study Summary

This trial aims to study the effectiveness, safety, and how the body processes vixarelimab compared to a placebo in people with moderate to severe ulcerative colitis who have not responded well to

Who is the study for?
This trial is for people who have been living with ulcerative colitis (UC) for at least three months. It's specifically aimed at those whose UC is moderate to severe and haven't had success with, or can't tolerate, standard or advanced treatments.Check my eligibility
What is being tested?
The study tests Vixarelimab against a placebo in participants with moderate to severe UC. The goal is to see if Vixarelimab is effective, safe, and how the body processes it compared to a non-active treatment.See study design
What are the potential side effects?
While specific side effects of Vixarelimab are not listed here, common side effects from drugs treating UC may include headache, nausea, fever, infections and potential injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ulcerative colitis for at least 3 months.
Select...
My ulcerative colitis is moderate to severe.
Select...
My UC treatments have not worked or caused side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants with Clinical Remission
Secondary outcome measures
Number of Participants With Adverse Events (AE) by Severity
Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab
Proportion of Participants with Clinical Response
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vixarelimab Dose Regimen 2Experimental Treatment1 Intervention
Participants will receive vixarelimab SC during the induction period and the optional ATE period.
Group II: Vixarelimab Dose Regimen 1Experimental Treatment1 Intervention
Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,933 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
701 Patients Enrolled for Ulcerative Colitis
Clinical TrialStudy DirectorGenentech, Inc.
9 Previous Clinical Trials
2,060 Total Patients Enrolled

Frequently Asked Questions

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

What is the overall count of participants enrolled in this medical study?

"Indeed, as indicated on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially posted on January 15th, 2024 and most recently updated on January 12th, 2024. There are plans to enroll a total of 210 patients at a single designated site."

Answered by AI

Are there openings for new participants in this ongoing clinical trial?

"Indeed, as listed on clinicaltrials.gov, this trial is currently seeking suitable candidates. The initial posting of the trial occurred on January 15th, 2024 and the most recent update was made on January 12th, 2024."

Answered by AI

Has the FDA granted approval for the prescribed dosage regimen of Vixarelimab, known as Dose Regimen 1?

"Based on our evaluation, the safety of Vixarelimab Dose Regimen 1 is rated as a 2. This assessment reflects the available data supporting its safety in this Phase 2 trial; however, there is currently no evidence supporting its efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Regenerate Primary Medical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Regenerate Primary Medical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
2024. "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137183.
~140 spots leftby Sep 2026
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