Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vixarelimab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Vixarelimab | EXPERIMENTAL | Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period. |
| Name | Type | Description |
|---|---|---|
| Vixarelimab | DRUG | Vixarelimab will be administered as per the schedule specified. |
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 i...
Vixarelimab is being developed for the treatment of moderate to severe active ulcerative colitis, a form of inflammatory bowel disease. It is an investigational monoclonal antibody and has been studied in a Phase 1 clinical trial in adults with this condition. It is not approved for any indication.
Vixarelimab targets OSMR, the oncostatin M receptor. It is an inhibitor of this receptor, which is a signaling pathway implicated in inflammation. By binding to OSMR, vixarelimab is designed to block oncostatin M mediated inflammatory signaling in ulcerative colitis.
Vixarelimab is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in moderate to severe active ulcerative colitis.
Vixarelimab is in Phase 1 clinical development. The single completed trial was a Phase 1 study in participants with moderate to severe active ulcerative colitis. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
Vixarelimab has been evaluated in one clinical trial, NCT06693908, titled A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis. The Phase 1 trial enrolled 24 adults in Germany and is now completed.
The Phase 1 trial NCT06693908 was an uncontrolled, open-label study, meaning it was not randomized and not double blinded. It enrolled 24 participants aged 18 years and older of all sexes in Germany. Participants had moderate to severe active ulcerative colitis, and the study is completed.