Estado De Mexico

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

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.

This research aims to compare changes in body mass index BMI Z-score in children and adolescents with schizophrenia or bipolar I disorder who are treated with either a combination of olanzapine and samidorphan OLZSAM or olanzapine alone. The study focuses on evaluating weight gain differences between these treatments over time. The trial is a Phase 3, randomized, double-blind study sponsored by Alkermes, Inc., involving pediatric patients aged 10 to 17 years. Participants will be randomly assigned to receive either the fixed dose combination OLZSAM or olanzapine alone. The olanzapine starting dose will be 2.5 mgday or 5 mgday based on the Investigators decision, with a maximum dose of 20 mgday. Samidorphan will be given at a starting dose of 5 or 10 mg. The study duration is 52 weeks, during which participants will be monitored for changes in BMI Z-score and other health measures. During the study, participants will undergo evaluations including BMI measurements at baseline and week 12, waist circumference, and psychiatric assessments using scales like PANSS, YMRS, and CDRS-R. Researchers will also monitor adverse events and track treatment discontinuation over 52 weeks. The main outcome is the change in BMI Z-score at week 12, with additional assessments of symptom changes and safety throughout the study period.