La Habra

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

This research aims to evaluate the effectiveness and safety of adding KarXT to current treatment for mania in adults with Bipolar-I Disorder. Participants must be experiencing an acute manic episode, with or without mixed features, and currently taking lithium, valproate, or lamotrigine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing KarXT as an adjunctive therapy. Participants will be randomly assigned to receive either KarXT combined with lithium, valproate, or lamotrigine, or a placebo combined with these mood stabilizers. The study drug or placebo will be administered at specified doses on designated days. The trial focuses on treatment during an acute manic episode with monitoring over several weeks to assess changes in mania symptoms and other clinical outcomes. Participants will be monitored through scheduled visits where researchers will measure changes in mania severity using the Young Mania Rating Scale YMRS and other clinical scales. Safety assessments will include tracking adverse events and evaluating other symptom scales related to bipolar disorder. The total study duration includes treatment and follow-up periods lasting up to seven weeks, during which participants health and responses to the study drug are carefully observed.

Researchers are evaluating the drug NBI-1117568 in adults with schizophrenia to see if it can delay the return of symptoms after a stable response to initial treatment. This phase 3 study compares NBI-1117568 with a placebo in a randomized, double-blind format to assess both its effectiveness and safety. The trial is sponsored by Neurocrine Biosciences and focuses on adults aged 18 to 65 years who have been diagnosed with schizophrenia for at least one year and have previously responded to antipsychotic therapy other than clozapine. All participants first receive NBI-1117568 during an open-label stabilization period to achieve symptom control. After this, participants are randomly assigned to continue with either NBI-1117568 or a placebo during the double-blind treatment period, which lasts up to approximately 30 weeks. Both treatments are given as oral capsules, and the study uses a quadruple-blind design to ensure unbiased results. Participants will be closely monitored throughout the study for symptom relapse, with the primary outcome measuring the time from randomization to relapse. Assessments include psychiatric evaluations and safety checks to monitor tolerability of the drug. The total participation duration includes the stabilization phase and the double-blind treatment period, providing detailed information on the drugs ability to maintain symptom stability in schizophrenia over time.

Researchers are evaluating the long-term safety and tolerability of a drug called NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, open-label study aims to monitor participants over an extended period to better understand how the drug affects people with this condition and to gather important safety information. Participants in this study will take NBI-1117568 once daily by mouth for up to 36 months. This single treatment group will allow researchers to observe the effects of the medication over a long duration without comparing to a placebo or other treatments. During the study, researchers will track any treatment-emergent adverse events experienced by participants to assess safety. Participants will be monitored regularly throughout the 36 months for their health and response to the drug. This ongoing observation helps ensure participant well-being and collects valuable data on how the drug performs long-term.