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Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are conducting a Phase 2 study to assess the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. The study includes participants who have not responded to at least two different small molecule migraine preventive treatments and are either eligible but have not used aCGRP therapies or have previously failed one or more aCGRP preventive treatments. This research aims to improve migraine prevention options for these individuals. Participants will receive subcutaneous injections of MEDI0618 or placebo in a double-blind, randomized design. The study has multiple dosing arms including Dose A and three additional doses for the group not previously treated with aCGRP therapies, with participants assigned in a 11 ratio to either active drug or placebo. A separate group who have failed aCGRP therapies will also be randomized 11 to receive MEDI0618 or placebo. The treatment period includes repeated dosing and evaluation of the drugs impact on migraine occurrence. Throughout the study, participants will be monitored for migraine headache days and the severity and disability caused by migraines from baseline through treatment. Evaluations will occur regularly from Day 1 to Day 141, including assessments focusing on migraine frequency between Weeks 9 and 12. Safety and efficacy will be closely observed in a controlled setting, and the study is expected to conclude in May 2027.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of two drugs, EXV-802 and EXV-801, for treating agitation in people with Alzheimers Disease dementia. This Phase 23 clinical trial is multicenter, double-blind, placebo-controlled, and includes about 300 participants diagnosed with Alzheimers-related agitation based on established criteria and biomarkers. The trial is sponsored by Exciva GmbH and conducted in the US, Canada, and Europe. Participants will be randomly assigned to one of three groups receiving EXV-802 capsules, EXV-801 capsules, or placebo capsules, each taken twice daily for 6 weeks. Before treatment, a screening period of about 4 weeks will ensure participants meet all criteria. The trial compares these treatments to assess potential benefits and safety. During the study, participants will be monitored regularly, including assessments of agitation severity using the Cohen-Mansfield Agitation Inventory and Clinical Global Impression of Severity scores at baseline and after 6 weeks. Caregivers will play a key role by being in contact with participants for at least two hours on four separate days weekly. Safety and treatment effects will be followed throughout the trial until its completion in 2029.