Estado De Mexico

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating weight gain in children and teenagers with schizophrenia or bipolar I disorder by comparing changes in body mass index (BMI) Z-score after treatment with a combination drug called OLZ/SAM versus olanzapine alone. This Phase 3 study focuses on pediatric patients aged 10 to 17 years and aims to understand how these treatments affect BMI over time. The study involves two treatment groups: one receiving OLZ/SAM, which combines olanzapine and samidorphan, and the other receiving olanzapine alone. The starting dose of olanzapine will either be 2.5 mg or 5 mg daily, based on the investigator's choice, with a maximum dose of 20 mg per day. Samidorphan doses will start at either 5 or 10 mg. Treatment lasts for up to 52 weeks under a randomized, double-blind design. Participants will be monitored through 12 weeks for changes in BMI Z-score, with ongoing assessments throughout the study. The study includes outpatient visits and requires reliable family or guardian support for managing treatment. Researchers will evaluate weight changes and monitor safety, including mental health status and potential side effects, to collect comprehensive data on treatment impact during the year-long period.