Fairborn

Researchers are evaluating 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 a Phase 3 trial that includes two parts: Part A with both children and teenagers, and Part B with only children. Initially, only teenagers who meet the study rules can participate, and children may join once enough information from other studies is available. Participants in Part A will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all participants will receive zasocitinib for the remainder of the study. Participants in Part B will receive zasocitinib throughout the study. Dosages are given orally once daily, with doses adjusted by weight for children aged 4 to under 12 years, and a fixed dose for teenagers aged 12 to under 18 years. The study includes a double-blind placebo-controlled period followed by an open-label period. Participants will be involved for up to 4 years and 2 months, including up to 35 days for screening, 208 weeks of treatment, and a 4-week safety follow-up. During this time, participants will visit the study site multiple times for assessments, including skin evaluations, quality of life questionnaires, and blood tests to monitor drug levels and safety. Researchers will measure how many participants achieve clear or almost clear skin, improvements in psoriasis severity scores, quality of life improvements, and monitor the medicine's concentration in the body.

Researchers are collecting long-term safety and effectiveness data of unilateral thalamotomy using the Exablate Neuro system for people with medication-refractory tremor dominant Parkinson's 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 treatment's 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, Parkinson's 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.

Atopic dermatitis (AD) is a skin condition causing rash and itching due to skin inflammation. This research compares two treatments, upadacitinib and dupilumab, in children aged 2 to less than 12 years with moderate to severe AD who need systemic anti-inflammatory therapy. The study aims to assess side effects and changes in disease activity while participants receive these treatments. Participants will receive either upadacitinib as a daily oral tablet or oral solution for up to 160 weeks or dupilumab by subcutaneous injection following its approved schedule for 52 weeks. Some participants will be randomized to receive medium or low doses of upadacitinib or dupilumab injections every 2 or 4 weeks, with dosing and grouping based on disease severity, age, and prior treatment response. Throughout the study, participants will attend regular hospital or clinic visits for clinical exams, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers will measure improvements in eczema severity, itch, quality of life, and record adverse events. Follow-up will continue for 30 days after upadacitinib and at least 12 weeks after dupilumab treatment ends to ensure safety and monitor long-term outcomes.

Researchers are evaluating the pharmacokinetics and safety of bimekizumab in children and adolescents aged 9 to 17 years with moderate to severe hidradenitis suppurativa (HS). This study focuses on understanding how the drug behaves in the body when given by subcutaneous injection and aims to gather important safety information in this younger population. Participants must have had HS for at least six months and show certain disease severity and characteristics to join the study. Participants will receive bimekizumab doses adjusted based on their weight, administered at specific scheduled times during the study. This is an open-label trial where all participants receive the drug, and no placebo or comparator group is used. The study primarily measures the concentration of bimekizumab in the blood at Week 16 to understand drug exposure. Throughout the study, participants will undergo various assessments including monitoring for side effects, vital signs, and detailed laboratory tests such as blood chemistry and hematology at multiple time points up to Week 16. Researchers will also check for anti-drug antibodies and track safety events related to infections and other concerns. The total study duration extends up to about four years, ending in 2029, with careful safety follow-up and data collection to evaluate the treatment's profile in this population.

Researchers are investigating treatments for adults in the US with moderate to severe chronic spontaneous urticaria (CSU) that is not well controlled by second generation H1-antihistamines (sgH1-AHs). The study is a Phase 3b, randomized, double-blind trial comparing remibrutinib, taken orally twice daily, to dupilumab, given as injections every two weeks, both added to standard antihistamine therapy. The trial aims to assess the early effectiveness of these treatments, focusing on improvements within the first four weeks. The trial includes a screening period up to 4 weeks to confirm eligibility, followed by a 12-week core treatment phase where about 400 participants will receive either remibrutinib with placebo injections or dupilumab with placebo tablets, alongside stable sgH1-AH background therapy. Participants can use additional antihistamines as rescue therapy if needed, up to a maximum daily dose. After the core phase, participants may join an optional 12-week open-label extension to receive remibrutinib, depending on its commercial availability. Safety follow-up continues for all participants, with phone calls and visits scheduled up to 24 weeks or longer if the extension continues. During the study, participants will complete daily diaries to track symptoms, and researchers will measure changes in urticaria activity scores at various time points, emphasizing Week 4. Safety and response will be monitored throughout, including phone follow-ups and site visits. Those who do not enter the extension will have safety calls at Weeks 16 and 24, while those in the extension will have continued monitoring until treatment ends or remibrutinib becomes commercially available. The total time involved may extend beyond 24 weeks depending on treatment continuation.

Researchers are evaluating the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis, a skin condition. This global Phase 3 clinical study aims to better understand how well the cream works and how safe it is for this very young age group. Participants will be randomly assigned to apply either tapinarof cream or a vehicle cream (a placebo) once daily to affected skin areas for up to 8 weeks during a double-blind period. After this phase, all participants may use tapinarof cream once daily as needed during an open-label period lasting up to 56 weeks. The study compares the effects of tapinarof cream against the vehicle cream and monitors participants over time. Throughout the study, caregivers and researchers will assess skin improvement using the Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and the Eczema Area and Severity Index (EASI). Safety will be closely monitored by recording any treatment-related side effects and local skin reactions. The trial includes regular visits and evaluations over the initial 8-week double-blind phase and continued monitoring during the longer open-label phase, which can last up to 56 weeks in total.

Researchers are evaluating the long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems used for various movement disorders, including Parkinson's 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 Parkinson's 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 medicine's effects and patient health throughout the trial.

Researchers are studying how the skin of night shift workers responds to artificial sunlight, specifically ultraviolet B radiation (UVB), compared to day shift workers. The study aims to understand differences in DNA repair activity and clock gene expression in skin exposed to UVB at two different times of day. This research focuses on skin cancer risk factors related to work schedules and skin response to UVB radiation. The study involves taking skin punch biopsies from both day and night shift workers. These biopsies will be brought to a laboratory where they will be exposed to UVB radiation or kept as non-irradiated controls. After one hour of incubation from UVB exposure, various DNA repair factors, core clock genes, and DNA damage signaling pathways will be measured. Participants will fall into two groups based on their work schedules: those working primarily daytime shifts and those working primarily night shifts. Participants will provide information about their work schedules over the past three months and undergo skin biopsies for laboratory testing. Researchers will evaluate the expression levels of DNA repair proteins, activity of DNA repair systems, and activation of DNA damage signaling after UVB exposure. The study includes assessments at two times of day to compare biological responses. The total study participation involves skin biopsies and data collection related to work schedules and skin type.

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.