Fuquay-Varina

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.