Evaluating Vixarelimab for Moderate to Severe Ulcerative Colitis
A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis
This study is testing a new treatment called vixarelimab to see if it can help people with moderate to severe ulcerative colitis who haven't had success with other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Drugs / interventions | radiation, vixarelimab |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06693908 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of vixarelimab, a new treatment, on patients with moderate to severe active ulcerative colitis. It focuses on understanding the drug's pharmacodynamic effects in the gut. Participants must have a diagnosis of ulcerative colitis for at least three months and have failed previous therapies. The study is designed to assess both the safety and activity of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate to severe active ulcerative colitis who have not responded to previous therapies.
Not a fit: Patients with Crohn's disease, indeterminate colitis, or those who have undergone prior colectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate to severe ulcerative colitis.
How similar studies have performed: While this approach is novel, similar studies targeting ulcerative colitis have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of UC established at least 3 months * Moderately to severely active UC * Participants must meet criteria for either advanced therapy failure or conventional therapy failure Exclusion Criteria: * Diagnosis of Crohn's disease or indeterminate colitis * Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis * Prior colectomy * Prior treatment with systemic janus kinase (JAK) inhibitors
Where this trial is running
Berlin
- Charité Research Organisation GmbH — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: GA45735 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.