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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Age: 16Years - 80YearsAll GendersPhase 3
200 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

Age: 16Years - 80YearsAll GendersPhase 3
196 locations
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Actively Recruiting

Researchers are evaluating the efficacy of the drug RO7837195 compared to a placebo in adults with moderately to severely active ulcerative colitis UC who have not responded well to conventional or advanced treatments. This Phase IIb study aims to assess the safety, pharmacokinetics, and clinical effects of RO7837195 in this patient group. The study is sponsored by Genentech, Inc. and focuses on treatment outcomes including clinical remission at Week 12. Participants undergo a screening period lasting up to 5 weeks, followed by a 12-week induction phase where some receive RO7837195 and others receive a placebo. After this, all participants enter a 40-week active treatment extension phase receiving RO7837195 regardless of their initial response. This design allows comparison during induction and continued treatment for all in the extension phase. Safety follow-up occurs after the last dose of study treatment. Throughout the trial, participants will be monitored for clinical remission, response, and endoscopic improvements at Week 12, as well as adverse events and drug concentration levels up to Week 65. The study includes regular evaluations such as clinical assessments and laboratory tests to track treatment effects and safety. Total participation can last up to approximately 57 weeks, covering screening, treatment, and follow-up periods.

Age: 18Years +All GendersPhase 2
103 locations
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Actively Recruiting

Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.

Age: 18Years - 75YearsAll GendersPhase 2
149 locations