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Monoclonal Antibodies

RO7790121 for Ulcerative Colitis (Ametrine-1 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
Moderately to severely active UC assessed by mMS
Must not have
Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Current diagnosis or suspicion of primary sclerosing cholangitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 2, week 12, and week 52
Awards & highlights
Pivotal Trial

Summary

This trial will test a new drug called RO7790121 to see if it is effective and safe for treating ulcerative colitis. Participants with moderately to severely active ulcerative colitis will be involved

Who is the study for?
This trial is for people with moderately to severely active ulcerative colitis, which is a type of inflammatory bowel disease causing ulcers and long-lasting inflammation in the digestive tract.
What is being tested?
The study tests RO7790121 against a placebo to see if it's more effective and safe as an induction and maintenance therapy for ulcerative colitis. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo.
What are the potential side effects?
While specific side effects of RO7790121 aren't listed here, common ones for UC treatments include headache, nausea, increased risk of infection, injection site reactions, and potential liver issues.

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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My ulcerative colitis is moderate to severe.
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My weight is at least 40 kg.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2, week 12, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2, week 12, and week 52 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 at Week 12
Percentage of Participants with Clinical Remission at Week 52
Secondary study objectives
Change in Abdominal Pain
Change in Bowel Urgency
Change in Fatigue
+14 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
2,457 Previous Clinical Trials
1,097,312 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,766 Patients Enrolled for Ulcerative Colitis
Chugai PharmaceuticalIndustry Sponsor
97 Previous Clinical Trials
22,044 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,227 Previous Clinical Trials
896,002 Total Patients Enrolled
12 Trials studying Ulcerative Colitis
4,190 Patients Enrolled for Ulcerative Colitis
~267 spots leftby Jun 2027
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