Kazanlak

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

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 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.

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 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.

Researchers are evaluating the drug NBI-1117570 for its effects on behavioral and psychological symptoms in adults with schizophrenia who need inpatient hospitalization. This phase 2a study compares NBI-1117570 to a placebo to assess its efficacy, safety, tolerability, and how the drug is processed in the body. Participants will be randomly assigned to one of three groups a lower-dose NBI-1117570 group, a higher-dose NBI-1117570 group, or a placebo group. The drug and placebo are given orally. The study uses a parallel design with quadruple masking to maintain blinding. The primary treatment period lasts 35 days, after which safety and adverse events are monitored up to 49 days. During the study, participants will have assessments to measure changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also track any treatment-emergent adverse events throughout the treatment and follow-up periods. The trial is sponsored by Neurocrine Biosciences and runs from February 2026 to August 2027.

Researchers are evaluating the safety, tolerability, and treatment response of GXV813 in adults hospitalized with schizophrenia who are experiencing an acute episode. This Phase 2a study aims to better understand how GXV813 affects symptoms of schizophrenia compared to a placebo in a controlled hospital setting. Participants will be randomly assigned to receive either GXV813 or a placebo, both given orally. The study uses a parallel-group design with quadruple masking to minimize bias. Treatment and observations will last for up to 6 weeks during hospitalization, focusing on symptom changes and drug pharmacokinetics. During the study, participants will be closely monitored with psychiatric assessments including the Positive and Negative Symptom Scale PANSS and Clinical Global Impression-Severity CGI-S scale. Researchers will also track safety, tolerability, and drug levels in the blood. The total participation time is about 6 weeks, with regular evaluations to measure changes from baseline symptoms and any adverse events.