Lighthouse Point

Researchers are evaluating SAR442970, a drug given by injection under the skin, for adults with moderate to severe Crohns disease. This phase 2b, randomized, double-blind study compares two different doses of SAR442970 with placebo to understand its effects on the condition. The study aims to measure how many participants achieve an endoscopic response by Week 16, among other clinical improvements. Participants are randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or placebo. Treatments are given subcutaneously, and the study includes a treatment period lasting up to 158 weeks. There is also an open-label long-term extension phase lasting up to 104 weeks for those who qualify, allowing continued evaluation of SAR442970s effects over time. During the study, participants will undergo assessments including endoscopic exams, clinical remission evaluations using the Crohns Disease Activity Index CDAI, patient-reported outcomes, and quality-of-life questionnaires. Safety is monitored by tracking adverse events and measuring drug levels in the blood. The total participation time can be up to 168 weeks, with ongoing evaluations to assess both short- and long-term outcomes.

Researchers are investigating the effectiveness and safety of SAR442970 in adults with moderate to severe Ulcerative Colitis in a phase 2b randomized, double-blind study. The trial compares two different doses of SAR442970 against a placebo to see how well they work in treating this condition. The total study duration can last up to 168 weeks, including a long-term extension period for eligible participants. Participants will be randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or a matching placebo, all given by subcutaneous injection. The study includes a treatment period lasting up to 158 weeks, followed by an open-label long-term extension phase of up to 104 weeks for those who qualify. Throughout the study, participants will undergo regular assessments to measure clinical remission using the modified Mayo Score at Week 16, as well as other outcomes such as endoscopic improvement, histological remission, and patient-reported outcomes. Safety will be monitored by tracking adverse events. Blood samples for drug concentration and antibodies will also be collected. The overall participation may last up to approximately 164 weeks.

Researchers are evaluating the safety and effectiveness of LY4268989 combined with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis. This phase 2 study aims to understand if the combination can better manage the condition. The study is sponsored by Eli Lilly and Company and involves a randomized, double-blind design with parallel groups. Participants receive either LY4268989 orally along with mirikizumab given intravenously and then subcutaneously, or mirikizumab with a placebo pill matching LY4268989. Responders to treatment will be re-randomized for a second study period. Treatment lasts approximately 104 weeks with up to 21 visits planned throughout the study. During the study, participants undergo assessments including clinical remission evaluation using the modified Mayo Score at weeks 12, 24, and 48, endoscopic improvement, and symptomatic remission measurements. Safety and response are closely monitored through scheduled visits. Overall participation lasts about 118 weeks, allowing researchers to gather long-term data on the treatments being studied.