Bryant

Researchers are evaluating the clinical efficacy, safety, and tolerability of 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 focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Vitiligo is a long-term autoimmune condition where the immune system mistakenly attacks skin cells that produce pigment, leading to patches of skin that lose color. This study focuses on adults with nonsegmental vitiligo, where symmetrical patches of depigmentation appear on both sides of the body. The trial aims to evaluate the safety, effectiveness, and tolerability of zasocitinib in treating this condition in adults aged 18 to 75 years. Participants will receive either zasocitinib capsules or placebo capsules that look identical but contain no medicine. The treatment period lasts up to one year (52 weeks). Those initially receiving placebo will switch to zasocitinib after about six months. During the study, participants will visit the clinic 11 times for treatment and monitoring. Throughout the trial, researchers will assess how well participants respond to treatment by measuring improvement in facial vitiligo using a standardized scoring index at baseline and after 24 weeks. Additional evaluations include safety monitoring and adherence to the study procedures. Participants will undergo clinical assessments, laboratory tests, and provide informed consent before starting the trial.

Bipolar disorder is a serious, long-lasting mood disorder affecting adults and children in the United States. This study evaluates the safety and effectiveness of Icalcaprant, an investigational oral medication, in adults with bipolar I or II disorder who are experiencing depressive episodes. The trial is a Phase 2, double-blind, placebo-controlled study involving about 195 adult participants across approximately 35 U.S. sites. Participants are randomly assigned to one of three groups, including a placebo group, to receive oral capsules of either Icalcaprant or placebo once daily for 6 weeks. Following treatment, there is a 4-week safety follow-up period to monitor participants' health and any side effects. The study assesses changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and tracks any adverse events during the approximately 10-week period. Throughout the trial, participants will visit clinics or hospitals regularly for medical assessments, blood tests, and questionnaires to monitor their condition, side effects, and overall health. Researchers will measure the change in depression symptoms from baseline to Week 6 and record any adverse events up to about 10 weeks. Participants' treatment adherence and safety are closely observed during the study and follow-up periods.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

This research aims to evaluate how effective valbenazine is in improving symptoms reported by both doctors and patients in adults with tardive dyskinesia (TD). The study focuses on people who either continue to have symptoms while on a VMAT2 inhibitor or after stopping such treatment. Participants include adults diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who have had mild or greater TD for at least three months. Participants will take valbenazine capsules orally as the treatment being studied. The trial is an open-label Phase 4 study, meaning all participants receive valbenazine and both clinicians and patients will report on outcomes. It includes people who remain symptomatic while on deutetrabenazine or have stopped prior VMAT2 inhibitor treatment. The study does not mention a comparator group or placebo. During the study, researchers will measure changes in involuntary movements using the Abnormal Involuntary Movement Scale (AIMS) from the start to week 24. Participants will be assessed for both clinician- and patient-reported outcomes to understand symptom changes. Safety and symptom monitoring will occur throughout the 24-week period to observe the effects of valbenazine.

This research aims to evaluate the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis. This global Phase 3 study focuses on infants and toddlers with this skin condition, assessing improvements in their skin from baseline through up to 56 weeks. The study compares tapinarof cream with a vehicle cream (placebo) to better understand its effects. Participants will be randomly assigned to receive either tapinarof cream, 1%, or a vehicle cream applied once daily to affected skin areas during the initial Double-Blind period lasting up to 8 weeks. Following this, all participants may enter an Open-Label Period lasting up to 56 weeks, where tapinarof cream will be applied once daily as needed to skin lesions. This design allows researchers to monitor responses to the medication over time and assess longer-term safety and efficacy. Throughout the study, caregivers and researchers will monitor the children's skin condition using a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, focusing on the proportion of participants achieving clear or almost clear skin and a significant improvement from baseline. Safety assessments and adherence to treatment protocols will be observed. The total study duration includes both the Double-Blind and Open-Label periods, with evaluations spanning up to 56 weeks to gather comprehensive data on treatment outcomes.

Researchers are studying the effectiveness, safety, and tolerability of ponsegromab combined with standard chemotherapy compared to chemotherapy with placebo in adults who have cachexia and metastatic pancreatic ductal adenocarcinoma. This Phase 2b/3 study includes participants who have already completed initial chemotherapy cycles and aims to evaluate ponsegromab as a first-line treatment option for this condition. The study includes a randomized, double-blind design conducted across multiple centers and countries. Participants will receive either one of two doses of ponsegromab or a placebo, both given alongside standard chemotherapy regimens such as nab-paclitaxel plus gemcitabine or FOLFIRINOX. The study intervention is administered subcutaneously every four weeks. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants may continue or switch doses accordingly while maintaining blinding. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind study period. During the study, participants will undergo tumor assessments every 6 to 8 weeks by independent radiologists. Researchers will measure body weight changes and anorexia symptoms over 12 weeks to assess treatment impact. The study also includes a caregiver sub-study to explore the quality of life and well-being of primary caregivers. Treatment continues until discontinuation, withdrawal, death, or study completion based on overall survival events.

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. This study aims to describe how patients respond to KarXT treatment and the related adverse events as observed in routine clinical care. Participants receive xanomeline and trospium chloride (KarXT) following the product label instructions. They may either be starting KarXT treatment within 16 weeks with plans to stop previous antipsychotics or already on a stable antipsychotic regimen and switching to KarXT under their clinician's guidance. Other psychiatric medications like antidepressants or mood stabilizers can be continued at stable doses during the study. During the study, participants' treatment adjustments and switches are tracked from baseline up to 20 weeks. Researchers monitor treatment effectiveness and safety through regular clinical follow-up, recording any changes, side effects, or adverse events. The study relies on the treating clinician’s judgment to assess treatment progress and participant safety throughout the observation period.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.