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Monoclonal Antibodies

RO7790121 for Ulcerative Colitis (Ametrine-2 Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of UC
Bodyweight >= 40 kilogram (kg)
Must not have
Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 2 and week 12
Awards & highlights
Pivotal Trial

Summary

This trial will test a new drug, RO7790121, to see if it is effective and safe in treating people with moderate to severe ulcerative colitis.

Who is the study for?
This trial is for people with moderately to severely active ulcerative colitis, a type of inflammatory bowel disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.
What is being tested?
The study is testing the effectiveness and safety of RO7790121 as an induction therapy for ulcerative colitis. It's a Phase III trial where some patients will receive RO7790121 while others will get a placebo, without knowing which one they're getting.
What are the potential side effects?
While specific side effects aren't listed here, common ones in trials like this might include gastrointestinal symptoms, potential allergic reactions to the medication, headaches, fatigue, and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ulcerative colitis.
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I weigh at least 40 kg.
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I have tried at least one bladder cancer treatment without success or could not tolerate it.
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My ulcerative colitis is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a specific type of colitis.
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I have severe complications from ulcerative colitis.
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I have an ostomy or ileoanal pouch.
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I am currently diagnosed with or suspected to have primary sclerosing cholangitis.
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I have had abnormal growths in my colon that were not fully removed.
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I have active TB or untreated/under-treated latent TB.
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I have not taken any medications that are not allowed in this study, including anti-TL1A therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Clinical Remission
Secondary study objectives
Change in Abdominal Pain
Change in Bowel Urgency
Change in Fatigue
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RO7790121Experimental Treatment1 Intervention
Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo IV followed by placebo SC.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,452 Previous Clinical Trials
1,095,953 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,766 Patients Enrolled for Ulcerative Colitis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,221 Previous Clinical Trials
895,643 Total Patients Enrolled
12 Trials studying Ulcerative Colitis
4,190 Patients Enrolled for Ulcerative Colitis
~233 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
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