Pruritus (Itching)

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

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 31 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 AIs 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 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 drugs 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.

Researchers are creating a network of hospitals, labs, academic institutions, and healthcare organizations to provide annotated biospecimens for various types of medical research and education. These biospecimens will be used for biomarker discovery, diagnostic test development, therapeutics research, and training of researchers and physicians. Participants may be healthy or have medical conditions relevant to ongoing research needs. The study involves collecting remnant specimens originally obtained for clinical testing or specimens collected specifically for research, including biofluids, tissues, and cells. Participants may be identified during clinical care or recruited through outreach programs. Biospecimens may be distributed to various research entities such as academic institutions and companies for diverse research uses, including genetic testing, cell line development, and long-term storage. Participants may undergo minimal risk screening activities and provide biospecimens as needed. The research team will collect data over a 10-year period to support novel research uses. Biospecimens may be used for multiple research and educational purposes, including training laboratory technicians and physicians. The study includes participants aged 1 to 89 years and involves assessment of health status through medical record reviews and clinical exams when blood collection is needed.

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.