Moderate to Severe Ulcerative Colitis
Conditions
Brief summary
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
Interventions
DRUGVixarelimab
Vixarelimab will be administered as per the schedule specified.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Fibroblast Products From Colonic Tissue | Baseline up to approximately 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentration of Vixarelimab | Up to approximately 3 months |
| Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab | Up to approximately 3 months |
| Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale | Up to approximately 3 months |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed