Fairborn

Researchers are studying how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is divided into two parts Part A includes both children and teenagers, while Part B includes only children. Initially, only teenagers who meet the study requirements can participate, with children joining after sufficient information is collected from other studies. Participants in Part A will be randomly assigned to receive either zasocitinib or a matching placebo daily for the first 16 weeks, followed by open-label zasocitinib treatment until the study ends. In Part B, all children will receive zasocitinib throughout the study. The treatment doses for children will be based on their weight, and adolescents will receive a fixed dose. The study lasts up to 4 years and 2 months, including screening, treatment, and safety follow-up periods. During the study, participants will visit the study site multiple times for assessments. Researchers will measure improvements in skin condition using tools like the Static Physicians Global Assessment and Psoriasis Area and Severity Index at Week 16 and throughout the open-label period. Safety and drug levels in the body will also be monitored. After treatment, there is a 4-week safety follow-up. Overall, participants will be involved for up to 217 weeks, including screening, treatment, and follow-up.

Researchers are collecting long-term safety and effectiveness data of unilateral thalamotomy using the Exablate Neuro system for people with medication-refractory tremor dominant Parkinsons Disease TDPD. This observational post-approval registry is required following the approval of the Exablate Model 4000 Type 1.0 and 1.1 devices. The study focuses on patients who have already received this focused ultrasound treatment for tremor associated with TDPD. Participants have undergone unilateral thalamotomy targeting the ventralis medius region using the commercially available Exablate Neuro device. No new interventions are performed during this registry. Data collection includes monitoring medication use and various assessments over time to understand the treatments long-term impact. Participants are followed with assessments at baseline, 1, 3, 6, and 12 months after their procedure, then annually for up to five years. Researchers collect information on adverse events, clinical tremor ratings on medication, Parkinsons motor function, quality of life, and work productivity. The primary outcome is the evaluation of long-term adverse events over five years, alongside measuring tremor and motor symptom impact on disability.

This trial evaluates treatments for children aged 2 to under 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib to subcutaneous dupilumab, focusing on changes in disease activity and side effects. The study involves participants who need systemic anti-inflammatory therapy because topical treatments alone are insufficient. The trial is a phase 3, randomized study conducted worldwide with about 675 children. Participants receive either upadacitinib daily as oral tablets or solution for up to 160 weeks, or dupilumab injections every 2 or 4 weeks for 52 weeks, following approved dosing schedules. Some participants are randomized to receive different doses of upadacitinib or dupilumab. Participants are grouped based on disease severity, age, and prior treatment responses. After treatment, there is a follow-up period of at least 30 days for upadacitinib and 12 weeks for dupilumab to monitor safety. During the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers measure outcomes including the percentage of participants achieving significant reductions in eczema severity using specific scales at week 16 and other timepoints, as well as tracking adverse events up to week 172. The study aims to understand treatment safety and effectiveness over a long term.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab as add-on treatments for adults with moderate to severe chronic spontaneous urticaria CSU that is not well controlled by second generation H1-antihistamines sgH1-AH. This Phase 3b, multi-center, randomized, double-blind, double-dummy study focuses on early treatment effects within 4 weeks. The study addresses the need for better management of CSU symptoms such as hives and itch. Participants will be assigned to one of two treatment groups one group will receive remibrutinib tablets twice daily plus placebo injections, while the other group will receive dupilumab injections with matching placebo tablets. Both groups continue their stable background therapy of sgH1-AH daily. The study includes a screening period up to 4 weeks, a 12-week core double-blind treatment period, and an optional 12-week open-label extension where all participants may receive remibrutinib if it is not commercially available. After treatment, safety follow-up occurs for up to 12 weeks, with phone calls and possible site visits. Participants will be monitored through regular assessments including symptom severity scores, urticaria activity scores, and daily diaries. Safety follow-up includes phone calls and visits depending on treatment continuation. The main outcome is the change in weekly urticaria activity score at Week 4. Other measures include severity of hives and itch at Weeks 1 and 4. Total study participation may last up to 24 weeks, including optional extension and follow-up phases.

This clinical trial investigates the efficacy and safety of bimekizumab compared with placebo in adults with palmoplantar pustulosis PPP, a skin condition causing pustules on the palms and soles. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension, aiming to evaluate treatment responses and safety outcomes in participants diagnosed with PPP for at least 24 weeks and who are candidates for systemic therapy or phototherapy. Participants are randomly assigned to one of two groups one group receives bimekizumab for the entire study duration, while the other receives placebo initially before switching to bimekizumab in the maintenance phase. Treatments are given at specified time points throughout the study, which includes an initial treatment period followed by a maintenance period under open-label conditions. During the study, participants undergo assessments including the Palmoplantar pustulosis-Investigator Global Assessment PPP-IGA response at Week 16, Palmoplantar Pustulosis Area Severity Index PPPASI responses at Weeks 8 and 16, and quality of life evaluations via the Dermatology Life Quality Index DLQI. Researchers monitor pain scores, adverse events, and serious side effects from baseline through safety follow-up up to Week 117. Participants will be closely observed through regular visits and evaluations during these periods.

Researchers are evaluating the long-term safety and effectiveness of Abbott deep brain stimulation DBS systems used for various movement disorders, including Parkinsons disease, essential tremor, disabling tremor, and dystonia. This international, prospective, multicenter study collects data from patients implanted with Abbott DBS devices during routine clinical care to understand outcomes over time. Participants implanted with the Abbott DBS system will be observed without altering their treatment, as this is an observational study. The study follows subjects for five years from their initial programming visit to gather information on device performance and patient motor function over time. During the study, participants will have regular assessments using disease-specific motor rating scales such as MDS-UPDRS Part III for Parkinsons disease and FTM-TRS for tremor. Researchers will monitor changes in motor symptoms and record any serious device- or procedure-related adverse events. Study involvement lasts for five years, allowing long-term collection of safety and effectiveness data.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are investigating how skin from night shift workers responds to artificial sunlight, specifically ultraviolet B radiation UVB, compared to skin from normal day shift workers. The study focuses on measuring DNA repair activity and gene expression related to skin damage and repair mechanisms in individuals with different work schedules. This pilot study aims to better understand potential differences in skin responses that might relate to skin cancer risks among these groups. Participants will have a small skin punch biopsy taken, which will then be exposed in the laboratory to UVB radiation or kept as a non-irradiated control. The study includes two groups based on work schedule day shift workers and night shift workers. The biopsies are incubated for one hour after UVB exposure before further analysis. Both groups undergo the same laboratory procedures to compare skin responses under controlled conditions. During the study, participants will provide information about their work schedules for the past three months and confirm their skin type and health status. Researchers will assess several primary outcomes including the expression level of the DNA repair factor XPA, core clock gene expression, nucleotide excision repair activity, and activation of DNA damage signaling pathways in the skin after UVB exposure. The total participation period is not explicitly stated but involves biopsy collection and laboratory analysis, with safety screening to exclude those with photosensitivity or other health issues.

Rosacea is a common skin condition that causes easy blushing and redness, often worsened by sunlight exposure. Researchers are studying whether topical medications can reduce this sunlight-induced redness and irritation in people with rosacea. This Phase 2 trial aims to evaluate the effects of two topical drugs, imipramine and amitriptyline, on skin redness caused by ultraviolet B UVB light. Participants apply either 4% imipramine or 4% amitriptyline on a small area 2x2 cm of one cheek, while a vehicle control substance is applied on the other cheek. There are two experimental groups one receiving imipramine and vehicle, and the other receiving amitriptyline and vehicle. The treatments are applied directly to the skin, allowing comparison of redness on treated versus untreated areas. During the study, redness levels caused by UVB light will be measured at 10 minutes, 60 minutes, 120 minutes, and 24 hours after treatment application. Researchers will also monitor how well the skin tolerates each medication over these same time points. Participants may be monitored over several visits to assess skin reactions and medication effects. The trial is randomized and double-blind, ensuring unbiased evaluation of the treatments impact on sunlight-induced redness in rosacea.

Researchers are exploring how artificial sunlight, specifically ultraviolet B radiation UVB, affects the skin of young adults compared to older adults. The study focuses on understanding why skin cancer is more common in older skin, which may be due to differences in a protein called insulin-like growth factor-1 IGF-1. Young skin has higher levels of IGF-1, while geriatric skin has very little. This research aims to see if injecting IGF-1 into older skin can make it respond more like young skin when exposed to UVB. Participants will have small skin areas exposed to UVB to study the skins reaction. Some areas will receive injections of IGF-1, while others will get saline injections as a comparison. After injection, these areas will also be treated with UVB to observe changes. This study includes young adults and geriatric adults and compares their skin responses with or without IGF-1 treatment. During the study, researchers will monitor gene expression changes that protect skin cells from UVB damage, measured two days after treatment. Participants skin responses will be closely examined to understand the effects of IGF-1 injection. The study involves no blinding or randomization, and healthy volunteers with specific skin types and ages will be enrolled. The total duration for assessing the primary outcome is two days post-treatment.