Pruritus (Itching)

Prurigo nodularis (PN) is a skin condition marked by intensely itching nodules that cause uncontrollable scratching and skin injuries. Researchers are studying the long-term use of dupilumab (Dupixent®) in adults aged 18 and older with moderate-to-severe PN in a real-world setting in Germany. The study aims to describe the effectiveness and safety of dupilumab treatment and understand patient-reported outcomes over time. Participants in this non-interventional study receive dupilumab as prescribed by their treating physician according to standard medical practice. The study observes patients who start dupilumab treatment either at the beginning of the study or within the previous 7 days. The observational period lasts up to 2 years, with assessments at baseline, 1 month after starting treatment, and then every 3 months during the first year, followed by every 6 months during the second year. During the study, participants will have various evaluations, including medical history, current and previous treatments, biomarker and laboratory tests if available, and several patient-reported questionnaires on disease control, quality of life, itch severity, sleep, and psychological well-being. Researchers will monitor treatment patterns, dosing changes, discontinuations, adverse events, and the overall long-term safety and effectiveness of dupilumab. The main outcomes include improvements in disease severity and itch reduction at 6 months, with ongoing assessments throughout the study period.

Researchers are evaluating camoteskimab, a drug being studied in adults with moderate-to-severe atopic dermatitis. This phase 2b study is multicenter, randomized, double-blind, and placebo-controlled, aiming to assess the drug's effects compared to placebo. Participants include those who have not been treated before and those who have had an inadequate response to previous biologic therapies. The study has two parts: Part 1 is a 24-week period where participants are randomly assigned to one of four groups receiving one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, an extension period, all participants will receive camoteskimab. This design allows researchers to compare the drug doses with placebo initially and then provide treatment to all participants. Participants will be involved for at least 24 weeks in the placebo-controlled phase and beyond during the extension. They will undergo assessments including the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and peak itch ratings. Researchers will measure changes in eczema severity, itch intensity, and skin condition over time. Safety and adherence will be monitored throughout the study period to evaluate the drug's effects and tolerability.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of single ascending oral doses of PG-033 in healthy adults aged 18 to 45 years. The study also examines how a high-fat meal affects the pharmacokinetics of PG-033, explores its potential metabolites and metabolic pathways, and investigates its impact on the QTc interval. This is a phase I clinical trial conducted by Prime Gene Therapeutics Co., Ltd. The study includes two parts: a single ascending dose (SAD) study and a food effect (FE) study. In the SAD study, about 40 participants are randomized in a 3:1 ratio to receive either PG-033 or a placebo across five dose levels, increasing from low to high. The FE study is a two-period, two-sequence crossover design involving 12 participants divided into two groups, who receive PG-033 either on an empty stomach or after a high-fat meal, with a 7-day washout period between doses. Participants will undergo safety and tolerability assessments for up to 7 days in the SAD study and 14 days in the FE study. Researchers will measure pharmacokinetic parameters such as Cmax, Tmax, AUC, half-life, volume of distribution, clearance, and mean residence time within 3 days post-dose. The QT interval will be monitored up to 24 hours after dosing. Screening includes vital signs, laboratory tests, chest X-ray, and ultrasound to confirm health status. Participants will be monitored closely for any adverse effects throughout the study.

This research aims to evaluate the accuracy of the Belle.ai software in diagnosing common dermatologic diseases across different skin tones. The software uses deep learning technology to analyze clinical images of skin conditions and provides a differential diagnosis from a database of over 2,000 skin conditions based on more than 500,000 images. The study will determine how well the AI-generated diagnoses match those of dermatology experts. Participants who consent will have three images taken of their skin condition using the Belle.ai software. These images will be de-identified and uploaded into the system, where the software will generate a single list of possible diagnoses. Dermatology experts will then review the cases to compare their diagnoses with the AI results. The study will be conducted at dermatology clinics within the Advocate Health system. During the study, images will be captured and uploaded securely without any personal identifiers. The Dermatologic Review Committee will assess the concordance between the AI's primary diagnosis and expert opinions, aiming for greater than 80% agreement. Participants will not need to complete any additional forms, and their involvement primarily involves image capture during their clinic visit. The main outcome measured is the agreement between AI and physician diagnoses on the day of image capture.

Researchers are studying BGB-45035, a drug being evaluated for safety, tolerability, and how it behaves in the body when given in single and multiple doses. This first-in-human study includes healthy adults and later adults with autoimmune skin diseases like atopic dermatitis (AD) and prurigo nodularis (PN). The study aims to understand how the drug works and its effects over a treatment period lasting up to 24 months. The study is divided into several parts: Parts A through D involve healthy participants receiving single or multiple doses of BGB-45035 or placebo to assess safety and drug behavior, including a food effect study. Part E focuses on adults with moderate to severe AD or PN receiving BGB-45035 for up to 12 weeks to evaluate safety and tolerability. Part F examines the drug’s effects on skin biomarkers in healthy volunteers over about 3 weeks. Treatment is given orally, and dosing varies by study part. Participants will attend scheduled visits for treatment, safety monitoring, laboratory tests, and questionnaires. Researchers will monitor adverse events, vital signs, heart function, and lab values up to 30 days after the last dose. For those with AD or PN, changes in disease severity and itch intensity will be assessed through specific scales over 16 weeks. The total study duration varies by part but can last up to two years including follow-up.

Researchers are evaluating the pharmacokinetics and safety of Dupilumab in children and adolescents aged 6 months to less than 18 years with prurigo nodularis, a chronic skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to better understand how Dupilumab behaves in the body and its safety profile in this young population. Participants will receive Dupilumab administered by subcutaneous injection, with dosing based on their weight and age. The study includes three periods: a screening period lasting 2 to 4 weeks, a treatment period of 24 weeks during which Dupilumab is given, and a post-intervention follow-up period of 16 weeks. Each participant will have a total of 6 planned study visits over approximately 42 to 44 weeks. Throughout the study, participants will complete daily symptom diaries and undergo evaluations to measure Dupilumab concentration in the blood from Day 1 to Week 40. The study will also monitor any treatment-emergent or serious adverse events and check for the development of antibodies against Dupilumab. Safety and effectiveness assessments will continue during the follow-up period to ensure comprehensive monitoring of participant health and treatment response.

Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder during pregnancy characterized by itching and elevated levels of bile acids and liver enzymes. It increases the risk of complications such as preterm labor, fetal distress, and sudden intrauterine death. The incidence of ICP varies by region and ethnicity, with notable rates in parts of India. This study aims to explore bile acid metabolism and genetic mutations related to ICP in the Indian population, assessing how these factors affect pregnancy outcomes and quality of life. The study compares pregnant women diagnosed with ICP to healthy pregnant women of similar gestational age. Women with ICP will be identified based on symptoms like persistent itching and elevated serum transaminases or bile acids. Researchers will analyze serum bile acid profiles and genetic mutations, while also monitoring clinical outcomes and quality of life. Data will be collected at enrollment and delivery, with follow-up until delivery to record maternal and perinatal outcomes. Participants will undergo assessments including blood tests for bile acids and liver function, pruritus measurement using a visual analog scale, and evaluation of newborn health at delivery. Genetic testing will focus on specific gene mutations linked to ICP. The study will also gather information on related health conditions and family history. Researchers aim to identify markers for ICP prognosis and understand its impact on maternal well-being and neonatal health over the course of the pregnancy.

Researchers are evaluating whether cervical traction can help reduce the use of GABAergic medications, such as gabapentin or pregabalin, in people experiencing neuropathic itch on the scalp, arm, or upper back without primary skin rash. This pilot study aims to understand if using a neck traction device can lower medication dosage while managing itch severity. The study is sponsored by Mayo Clinic and focuses on adults aged 18 and older who are on stable doses of these medications. Participants will use a cervical traction device at home daily for 12 weeks while continuing their current prescriptions for gabapentin or pregabalin. Every two weeks during the study, participants will complete electronic surveys to report their itch severity. Based on these survey results, the study team may adjust their medication dosage by up to 33% to find the optimal treatment balance. During the 12-week period, participants will be regularly monitored through surveys assessing itch severity at multiple time points. Researchers will measure changes in GABAergic medication use from the start to the end of the study and track itch severity scores throughout. The study involves ongoing communication with the team, medication adjustments, and adherence to device use and questionnaire completion to evaluate treatment effects and safety.

Researchers are conducting a national multicenter prospective cohort study to better understand type 2 inflammatory skin diseases such as dermatitis, eczema, urticaria, pemphigoid, and prurigo nodularis. The study aims to improve diagnosis and treatment by systematically collecting data on current treatment status as well as the effectiveness and safety of various therapies in real clinical settings. This effort is led by the National Clinical Center for Skin and Immune Diseases and sponsored by Peking University First Hospital. This observational study does not involve experimental treatments but gathers information from patients receiving standard care at multiple medical units approved by the National Clinical Center for Skin and Immune Diseases. Data collection includes patient demographics, disease onset age, types of current therapies, and presence of related conditions. The study will follow patients for up to 120 months to observe treatment patterns and disease outcomes over time. Participants will provide information through questionnaires and clinical assessments at baseline and throughout the study period. Measures include the Eczema Area and Severity Index (EASI), Body Surface Area affected, quality of life questionnaires, and disease activity scores related to specific skin conditions. The research team will monitor changes in therapy use, disease severity, and patient quality of life to inform future care improvements. The study started in August 2021 and will continue until December 2031.

Researchers are evaluating the efficacy and safety of SHR-1819 injection in adults with Prurigo Nodularis, a skin condition characterized by itchy nodules. This multicenter trial is designed as a randomized, double-blind, placebo-controlled study combining Phase II and Phase III stages to assess the treatment effects over several weeks. The study aims to measure improvements in itch intensity and skin condition as primary outcomes, with additional focus on quality of life and immune response markers. Participants will be assigned randomly to receive either different doses of SHR-1819 injection or a placebo injection. The Phase II portion evaluates outcomes up to 16 weeks, while Phase III extends assessments up to 24 weeks and beyond. The study also monitors serum drug concentration, IgE levels, and immunogenicity to better understand the drug's behavior and patient response. During the study, participants will undergo regular evaluations including pruritus intensity scales, Investigator Global Assessment scores, and quality of life questionnaires. Blood samples will be taken to measure drug levels and immune markers. Safety and response data will be collected throughout the treatment period and follow-up visits, which may last up to 52 weeks, ensuring thorough monitoring of both efficacy and potential side effects.