Carlton

Researchers are evaluating the safety and effectiveness of different doses of ZL-1102 topical gel, a human VH IL-17A antibody fragment, in adults with chronic plaque psoriasis. This phase 2, randomized, double-blind, vehicle-controlled, dose-ranging study involves about 250 patients with plaque psoriasis affecting 3% to 15% of their body surface area, excluding the head. The study aims to compare various doses of ZL-1102 gel to a placebo gel over a 16-week treatment period. Participants are randomly assigned to one of five groups receiving different doses and frequencies of ZL-1102 gel or placebo gel. The treatment arms include ZL-1102 1% gel applied twice daily, ZL-1102 3% gel applied either once or twice daily, and placebo gel applied once or twice daily. Each participant undergoes 16 weeks of topical treatment with their assigned gel. During the study, participants will be regularly assessed for treatment effectiveness and safety. Researchers will monitor the response to treatment at Week 16, focusing on the comparison of different ZL-1102 doses against placebo. Patient evaluations include clinical examinations, laboratory tests, and safety monitoring. Participants are asked to avoid prolonged sun exposure and tanning devices during the study period. The total study duration for each participant is 16 weeks.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Hidradenitis Suppurativa (HS) is a skin condition causing deep, painful bumps that appear where skin rubs together. These bumps can swell, become red, and sometimes fill with pus, turning into abscesses that may burst. Over time, HS can lead to scars and tunnels on or under the skin. This study aims to evaluate how safe and effective the drug zasocitinib is for adults with moderate to severe HS, comparing it to a placebo in a Phase 2 trial. Participants will receive either zasocitinib or a placebo capsule daily for 16 weeks. The placebo looks the same but contains no medicine. After this initial 4-month period, all participants, including those who first received placebo, will be offered zasocitinib for up to an additional 8 months. Throughout the study, participants will visit the clinic 12 times for treatment and monitoring. During the visits, researchers will assess treatment response, including the percentage of participants achieving a 75% reduction in HS signs at week 16. They will also monitor safety and tolerance of the medication. Participants will undergo various evaluations such as physical exams, lab tests, and questionnaires to track disease progress and side effects. The study includes careful follow-up to ensure participant safety and to gather detailed information on the drug's effects over the total study duration of up to 12 months.

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 investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment to delay the return of depressive symptoms in adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have had moderate to severe recurrent MDD or persistent depressive disorder and have not responded adequately to oral antidepressant treatments. The goal is to maintain the positive effects of treatment and prevent relapse over a period of up to approximately 32 months. Participants receive either the study drug NBI-1065845 or a placebo in oral tablet form, both given alongside their ongoing oral antidepressant medications. They must continue their current antidepressant treatment at the same dose and frequency throughout the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatments. During the study, participants are monitored from the time of randomization until relapse or the study end, which may last up to 32 months. Researchers assess the time it takes for depressive symptoms to return, using measures such as the Hamilton Depression Rating Scale. Participants are expected to comply with all study procedures and restrictions, and safety monitoring is conducted throughout the study period.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

This research aims to evaluate the safety and tolerability of two new artificial tear formulations in adults with moderate dry eye disease. The study includes participants who experience dry eye symptoms and already use artificial tears. It is designed to better understand how these new eye lubricants are tolerated and their safety profile. Participants will receive two investigational eye drop products, one drop per eye of each formulation, in a cross-over design following a randomization schedule. Each participant will use both products during the study period. The total participation will last about 21 days, during which the effects of the two artificial tear formulations will be compared. Throughout the study, participants will attend visits including a screening and exit visit scheduled based on observed visit windows. Researchers will monitor the number of treatment-emergent adverse events, assess eye health through biomicroscopy, and measure best corrected visual acuity. These evaluations will take place from screening through the exit visit to ensure safety and tolerability of the treatments.

Researchers are investigating how different daily lengths of mindfulness meditation affect psychological wellbeing in healthy adults with little to no prior meditation experience. The study aims to determine whether longer daily meditation sessions produce greater improvements in wellbeing compared to shorter sessions. This randomized controlled trial explores dose-response effects by comparing three meditation durations against a minimal dose. Participants will be randomly assigned to one of four groups: 10 minutes, 20 minutes, 30 minutes, or 3-4 minutes of guided mindfulness meditation per day for 28 days. Meditation sessions involve listening to daily audio recordings from a specially developed program. Participants are asked not to engage in other mindfulness practices during this period, except for informal daily life practices. The trial includes a run-in period, the intervention itself, and a follow-up phase. During the study, participants will complete surveys and self-reported measures at baseline, mid-intervention (2 weeks), post-intervention (4 weeks), and follow-up (8 weeks). Researchers will monitor adherence, meditation experiences, and any adverse events. Outcomes focus on changes in psychological wellbeing and engagement levels across different dose groups. The total participation lasts approximately two months including follow-up assessments.