Vratsa

Researchers are evaluating the effectiveness and safety of oral AP1189 combined with methotrexate in adults with early rheumatoid arthritis who have not previously been treated with disease-modifying anti-rheumatic drugs DMARDs. This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 40, 70, or 100 mg impact disease activity and inflammation over 12 weeks in participants with active early rheumatoid arthritis. Participants will be randomly assigned to one of four groups, each receiving daily oral treatment for 12 weeks AP1189 at 40 mg, 70 mg, or 100 mg doses alongside methotrexate, or a placebo alongside methotrexate. The study compares the effects of these treatments on rheumatoid arthritis symptoms and inflammation to determine the best dose of AP1189 when combined with methotrexate. During the study, participants will attend scheduled visits for assessments including joint evaluations, blood tests for inflammation markers such as C-reactive protein CRP, and other safety monitoring. Researchers will measure changes in the Disease Activity Score 28 DAS28-CRP at 12 weeks to evaluate treatment impact. Participants will be monitored closely for safety and tolerability throughout the trial period, which lasts about 12 weeks.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

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.

Researchers are evaluating the proposed biosimilar MB04 compared to Enbrel, a known treatment, in patients with moderate to severe rheumatoid arthritis RA who continue to have active disease despite methotrexate therapy. The study aims to assess the effectiveness, safety, how the body processes the drugs, and immune responses to MB04 versus Enbrel. This phase 3 trial will include approximately 458 patients aged 18 to 75 years. Participants will receive a stable dose of methotrexate and folic acid before starting the study. They will be randomly assigned to receive a 50 mg weekly subcutaneous injection of either MB04 or EU-sourced Enbrel during the 36-week main treatment period. After 24 weeks, some patients initially on Enbrel will be re-randomized to either continue Enbrel or switch to MB04, while those on MB04 will continue the same treatment. Following treatment, patients will be monitored for safety for an additional 4 weeks. Throughout the study, patients will undergo regular assessments including measures of joint swelling and tenderness, and blood tests to evaluate inflammation and immune response. The primary outcome is the American College of Rheumatology 20% Response Criteria ACR20 at Week 24, with additional assessments at Week 36. Safety will be monitored continuously, and participant involvement will last approximately 40 weeks including follow-up.

Researchers are evaluating the effect of DT-101 compared to placebo in adults with Major Depressive Disorder MDD. This Phase 2 clinical trial aims to assess the safety, tolerability, and impact of DT-101 on depression symptoms in adults aged 18 to 75 years who have recurrent depression diagnosed by DSM 5-TR. The study is randomized, double-blind, and placebo-controlled, focusing on treatment for this condition. Participants will be assigned to one of three groups two experimental groups receiving different formulations of DT-101 DT-101 A or DT-101 B or a placebo group. The study involves regular clinic visits every couple of weeks where the study drug or placebo is administered and ongoing assessments are conducted. Blood and urine samples will be collected to monitor the drugs absorption and use in the body, including optional genetic testing to explore responses to DT-101. During the study, participants will undergo physical and neurological exams, clinical assessments, and complete questionnaires about their health and depression symptoms. The primary outcome measure is the change in depression severity using the Montgomery sberg Depression Rating Scale MADRS over 42 days. Safety and tolerability will be monitored throughout. Participation involves multiple visits for health checks and data collection until the study concludes in August 2027.

Researchers are evaluating KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.