Bryant

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 azetukalner as a treatment for adults diagnosed with moderate-to-severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color due to the immune system mistakenly attacking pigment-producing skin cells called melanocytes. This leads to patches of skin with less or no pigment, often appearing symmetrically on both sides of the body in the nonsegmental form of vitiligo. The study aims to evaluate the safety, effectiveness, and tolerability of the drug zasocitinib in adults with nonsegmental vitiligo. Participants will receive oral capsules of zasocitinib at low, medium, or high doses for up to 52 weeks. Some participants will initially receive a placebo for 24 weeks, then switch to medium or high doses of zasocitinib for the remainder of the study. The placebo capsules look identical to zasocitinib but do not contain active medicine. The study uses a randomized, double-blind design with several experimental groups receiving different doses or placebo. During the study, participants will visit the clinic 11 times over one year. Researchers will assess the improvement in vitiligo using facial and total Vitiligo Area Scoring Index F-VASI and T-VASI at baseline and week 24. Safety and tolerability will also be monitored throughout. The primary outcome is the percentage of participants achieving at least 75% improvement in F-VASI at week 24. Secondary outcomes include other measures of vitiligo area improvement. Participants health and response to treatment will be closely followed until the studys end.

This research aims to evaluate the safety and effectiveness of Icalcaprant in adults diagnosed with bipolar I or II disorder, specifically focusing on depressive episodes. Bipolar disorder is a chronic mood condition affecting a significant portion of the adult and pediatric populations in the United States. The study targets approximately 195 adult participants across about 35 sites in the U.S., aiming to understand how Icalcaprant impacts disease activity and adverse events. Participants are randomly assigned to one of three groups two groups receive different doses of oral Icalcaprant once daily for 6 weeks, and one group receives a matching placebo daily for the same period. After the treatment phase, all participants enter a 4-week safety follow-up period. The study uses a parallel design with quadruple masking to compare the effects of the investigational drug versus placebo. During the study, participants will attend regular visits at hospitals or clinics where they undergo medical assessments, blood tests, and complete questionnaires to monitor side effects and treatment effects. Researchers will measure changes from baseline to week 6 in depression severity using the Montgomery-sberg Depression Rating Scale and the Clinician Global Impression of Severity for bipolar disorder. Safety will be monitored up to approximately 10 weeks, ensuring participant well-being throughout the trial.

This research aims to evaluate the effectiveness of valbenazine in adults who have tardive dyskinesia TD and remain symptomatic while receiving or after stopping treatment with a vesicular monoamine transporter 2 VMAT2 inhibitor. The study focuses on both clinician- and patient-reported outcomes to better understand how valbenazine may impact TD symptoms. It is a Phase 4, open-label study sponsored by Neurocrine Biosciences. Participants will receive valbenazine capsules orally once daily for 24 weeks. The study involves a single treatment group with no placebo or comparator group. Valbenazine dosing and administration will be monitored throughout the 24-week treatment period. Participants will be assessed at baseline and at Week 24 for changes in abnormal involuntary movements using the Abnormal Involuntary Movement Scale AIMS. Additional evaluations include the Clinical Global Impression of Severity for TD, the Tardive Dyskinesia Impact Scale, and quality of life measures such as the EuroQol-Visual Analogue Scale. The study will monitor safety and efficacy over the 24 weeks of treatment, with total participation lasting approximately this duration.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride KarXT in adults diagnosed with schizophrenia in the United States. The study aims to understand how these medications are used and their impact on patients, including treatment switches and titration over time. Participants diagnosed with schizophrenia who have started treatment with KarXT will be observed according to the product label for up to 20 weeks. The study includes those newly starting KarXT or switching from other antipsychotic treatments, with data collected on dosing changes, adverse events, symptom improvement, and treatment continuation. During the study, participants will undergo regular clinical assessments, including monitoring of weight, psychiatric symptoms using the Clinical Global Impressions - Improvement score, and recording any schizophrenia-related relapses or hospital visits. Researchers will track medication adherence, reasons for stopping treatment, and use of antiemetic medications for gastrointestinal symptoms, with baseline and follow-up data collected up to 20 weeks.

Researchers are evaluating the effectiveness of NBI-1065890 compared to a placebo for treating tardive dyskinesia TD in adults. This Phase 2 study focuses on adults aged 18 to 75 with a confirmed diagnosis of TD caused by neuroleptic medication and other related psychiatric conditions such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. The study aims to assess the treatments impact on abnormal involuntary movements and overall improvement. Participants will be randomly assigned to receive either NBI-1065890 or a matching placebo, both taken orally. The study uses a parallel design with quadruple masking to compare the effects over an 8-week period. The main measurement is the change in the Abnormal Involuntary Movement Scale AIMS total score from baseline to week 8, along with secondary assessments of clinical global improvement. During the study, participants will undergo blinded video assessments of their movements, and their responses will be evaluated by expert raters. Researchers will monitor the severity of dyskinesia, psychiatric symptoms, and any side effects. The study includes regular visits over the 8-week treatment period, with safety and tolerability closely observed. Total participation lasts at least 8 weeks, concluding with the final evaluation of movement improvement.

Researchers are evaluating the long-term safety and tolerability of NBI-1065845 as an additional treatment for adults with Major Depressive Disorder MDD. This Phase 3, open-label study focuses on participants who have a primary diagnosis of recurrent moderate or severe MDD or persistent depressive disorder and have had an inadequate response to oral antidepressant treatments in their current depressive episode. Participants will receive NBI-1065845 tablets taken orally once daily as an adjunctive therapy alongside their ongoing antidepressant treatments. The study is designed as a single-group, open-label trial without placebo or comparison groups. The treatment period and follow-up extend over 52 weeks, during which safety and tolerability will be closely monitored. Throughout the study, participants will be assessed for treatment-emergent adverse events TEAEs from baseline through Week 52. Participants must be willing and able to comply with all study procedures and restrictions, including regular visits and evaluations determined by the investigators. The overall study duration allows for comprehensive monitoring of safety outcomes and participant well-being.

Researchers are evaluating the effectiveness of NBI-1065845 compared with a placebo as an additional treatment to improve symptoms in adults with major depressive disorder MDD. The study focuses on participants who have recurrent moderate to severe MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants in their current episode. This Phase 3 trial is designed to assess both the efficacy and safety of this investigational drug. Participants will be randomly assigned to receive either NBI-1065845 or a matching placebo, both administered orally once a day. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment duration lasts 56 days, during which participants continue their current oral antidepressant medication at the same dose. The study uses a parallel design with two groups receiving either the drug or placebo. During the trial, participants will be assessed at baseline and at Day 56 using several scales to measure changes in depression severity and disability. These include the Montgomery-5sberg Depression Rating Scale MADRS, the Sheehan Disability Scale SDS, and the Clinical Global Impression-Severity Scale CGI-S. Participants must comply with all study procedures and restrictions, and their safety and response to treatment will be closely monitored throughout the study period, which ends in July 2027.