Rogers

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode. The study focuses on participants aged 18 to 74 years who have bipolar depression, aiming to better understand treatment effects in this population. Participants will be randomly assigned to receive either azetukalner at a dose of 20 mg or a placebo, both taken orally once daily with food, preferably with the evening meal. The treatment period lasts for 6 weeks, during which participants will be monitored closely. During the study, participants will undergo assessments including evaluation of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Week 6. Researchers will monitor safety and treatment effects throughout the study. Total participation time covers the 6-week treatment period with ongoing monitoring of symptom changes and safety.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo. Participants must be adults between 18 and 74 years old, experiencing a current major depressive episode confirmed by standard diagnostic criteria and lasting between 6 weeks and 24 months. Participants are randomly assigned to receive either azetukalner 20 mg or a placebo, both taken orally once daily with food (preferably with the evening meal) for 6 weeks. The study compares these two groups to determine the impact of azetukalner on depressive symptoms. The trial maintains double-blinding to ensure unbiased assessment of outcomes. During the study, participants undergo regular assessments including evaluations of depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17) at baseline and at Week 6. Safety and tolerability are monitored throughout the treatment period. The total participation time corresponds to the 6-week treatment phase, during which symptom changes and adverse events are closely observed.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in reducing the chance of relapse to cigarette smoking in adults who have recently quit. This is a Phase 2, multicenter, randomized, double-blind study focused on adults aged 18 to 75 who want to maintain abstinence from smoking. The study aims to measure continuous abstinence confirmed by carbon monoxide levels from week 1 through week 24. Participants will receive either brenipatide or placebo administered subcutaneously during a 24-week treatment period. The study includes a 2-week screening phase before treatment begins and an 8-week safety follow-up after treatment ends. Treatment involves self-injection of the study drug or placebo, and participants are expected to attend up to 17 study visits throughout the approximately 34-week study duration. During the study, participants will be monitored regularly to confirm smoking abstinence and assess safety. Researchers will measure the percentage of participants who maintain continuous abstinence from smoking, verified by carbon monoxide levels. The study includes evaluation of adherence to treatment, safety assessments, and follow-up visits to monitor participants for any adverse effects or relapse.

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

Researchers are studying the safety and tolerability of XB371 in adults with locally advanced or metastatic solid tumors. This phase 1 trial includes both dose-escalation and expansion cohorts, with some groups randomized and others non-randomized to better understand XB371's effects. The study focuses on patients with recurrent advanced solid tumors who meet specific health requirements. Participants receive XB371 through intravenous infusion. The study has different parts: dose-escalation cohorts to find appropriate dosing, and expansion cohorts that include randomized and non-randomized groups to further evaluate treatment. The treatment cycles last 21 days, with close monitoring for dose-limiting toxicities and adverse events. Throughout the study, participants undergo regular assessments to monitor safety and treatment effects. Researchers track serious side effects up to about 7 months and specifically watch for dose-limiting toxicities during the first 21-day cycle. Participants must meet performance status and organ function criteria and have a life expectancy of at least 12 weeks. The study excludes those with certain brain conditions, infections, or recent major treatments to ensure participant safety.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the effectiveness and safety of BHV-7000 in adults with refractory focal onset epilepsy, a condition where seizures originate in one area of the brain and do not respond well to current treatments. This Phase 2/3 clinical trial aims to determine whether BHV-7000 can reduce seizure frequency in this population. The study is divided into two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000, or a matching placebo, taken once daily. After completing Part A, participants move to Part B, where they are randomized to receive 75 mg of BHV-7000 or a matching placebo, also taken once daily. Both parts are randomized and double-blinded to ensure unbiased results. Participants will be monitored from Week 8 to Week 20 of each part for changes in average seizure frequency, serious adverse events, discontinuations due to side effects, and laboratory abnormalities. Researchers will track seizure diaries and assess safety and tolerability throughout the study. The total duration includes both study parts with regular evaluations to measure the drug’s impact and participant safety.

Researchers are evaluating the safety and effectiveness of KarXT compared to a placebo for treating adults with Bipolar-I disorder experiencing an acute episode of mania or mania with mixed features. This Phase 3 study involves participants who require hospitalization due to their manic episode and aims to assess symptom improvement over a short-term inpatient period. The study lasts up to seven weeks, including screening, treatment, and safety follow-up. Participants will be randomly assigned to receive either KarXT or a placebo in specified doses during a three-week inpatient treatment period. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. The focus is on the change in mania symptoms measured by the Young Mania Rating Scale during the three weeks. Throughout the study, participants will be closely monitored with psychiatric evaluations and rating scales, including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Safety assessments continue during the follow-up period. The total participation time, from screening through treatment and safety monitoring, will not exceed seven weeks.