Dry Mouth (Xerostomia)

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are studying XmAb657 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adults and adults with autoimmune diseases such as idiopathic inflammatory myopathies, systemic sclerosis, and Sjogrens disease. This Phase 1, first-in-human study aims to understand how the drug behaves in the body and its potential effects. Participants will receive XmAb657 by subcutaneous injection under the skin in a dose-escalation design. The study includes both healthy volunteers and individuals diagnosed with specific autoimmune diseases. The treatment phase involves administering XmAb657 and monitoring responses over time. During the study, participants will undergo various assessments including safety monitoring for treatment-emergent and serious adverse events, blood tests to measure drug concentration, and evaluations of pharmacodynamic effects. Researchers will track these outcomes through Week 52. Participants are expected to follow contraception requirements and attend scheduled visits for monitoring throughout the study duration.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of CND319 in healthy adults and patients with rheumatic diseases such as rheumatoid arthritis and Sjogrens syndrome. This Phase 1, first-in-human study consists of two parts a dose escalation phase and an open-label expansion, aiming to better understand how CND319 behaves in the body and its initial impact on these conditions. Participants will receive CND319 according to the dosing schedule assigned to their cohort. The study includes single ascending dose SAD and multiple ascending dose MAD parts, with the open-label expansion providing further evaluation. The dose escalation part assesses increasing doses to understand safety and drug behavior, while the expansion phase allows additional participants to receive the drug openly. During the study, participants will be closely monitored through various assessments including vital signs body temperature, heart rate, respiratory rate, blood pressure, pulse oximetry, ECG parameters, and laboratory safety tests from baseline through up to 12 weeks for SAD or 24 weeks for MAD and open-label parts. Researchers will also track the presence of anti-drug antibodies and pharmacokinetic measures such as drug concentration and clearance. Total participation duration depends on the study part but may last up to 24 weeks.

Researchers are evaluating the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 rhPRG4 for people with Sjgrens Syndrome who have dry eye disease. This Phase II, multi-center, randomized, double-masked controlled study is conducted in Australia to compare rhPRG4 to a placebo vehicle. The study aims to help improve symptoms and signs of dry eye related to Sjgrens Syndrome. Participants are randomly assigned to receive either rhPRG4 at a concentration of 450 gml or a PBS-based vehicle control. The treatment is applied topically to the eyes. The study lasts for 28 days, during which participants use the assigned treatment following the prescribed regimen. The trial includes regular assessments to monitor safety and efficacy throughout this period. During the study, participants attend scheduled visits where researchers evaluate eye health using corneal staining tests, symptom questionnaires including the SANDE score and visual analogue scales for dryness and discomfort, and eye examinations such as slit lamp evaluations and intraocular pressure measurements. Safety is monitored by observing any adverse events and changes in vision. The main outcome is the frequency of patients achieving complete resolution of corneal staining by day 28. Participants are asked to adhere to the treatment schedule and attend all visits during the trial duration.

This research aims to evaluate the effects of a commercially available oil rinse product called PerioPull on dental health markers in adults. The study focuses on people with dental health issues, such as deeper-than-normal gum pockets that may harbor infection and cause inflammation leading to periodontal disease. The trial is a 12-week pilot study designed to assess whether PerioPull can improve common, validated dental health measures used in clinical practice. Participants will use PerioPull, a natural oil rinse containing ingredients like Medium Chain Triglycerides from coconut oil, Bixa orellana seed extract, natural mint flavor, bromelain, ubiquinone, and delta tocotrienols. They will swish approximately one teaspoon 5 mL of the oil in their mouth for at least five minutes daily after brushing, then spit it out without rinsing. This routine will be maintained daily for 12 weeks. Throughout the study, participants will attend three dental visits at baseline, six weeks, and 12 weeks. During these visits, dental health will be assessed using measurements such as plaque index, gingival index, and pocket depth. Oral samples will be collected and analyzed in a laboratory to further evaluate outcomes. Additional assessments include intraoral photos and MyPerioPath testing. These procedures align with standard dental exams and will help researchers monitor changes in dental health over the study period.

Researchers are evaluating spermidine as a potential way to prevent radiation-induced dry mouth xerostomia in patients undergoing radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. This single-center, double-blind, randomized controlled trial compares spermidine capsules to placebo capsules to understand if spermidine can reduce this common side effect during treatment. Participants will take spermidine capsules or matching placebo capsules twice daily with meals, starting one week before radiotherapy or concurrent chemoradiotherapy and continuing until one week after completing radiotherapy. Both groups also receive routine health education, nursing care, and treatment as usual. The study maintains a quadruple-blind design to keep treatment assignments unknown. During the trial, radiation-induced xerostomia will be assessed weekly from the start of radiotherapy through three months after its completion, about 18 to 19 weeks in total. Additional measures include unstimulated salivary flow rates and quality of life questionnaires at several key time points. Participants will be monitored closely for treatment adherence and safety throughout the study period.

Researchers are evaluating CLN-978, a CD19-directed T cell engager given by subcutaneous injection, in adults with active, moderate to severe Sjogrens Disease. This phase 1b, open-label study aims to assess the safety and tolerability of CLN-978 over 48 weeks in patients who meet specific disease criteria and laboratory parameters. Participants receive CLN-978 in two parts an initial dose escalation phase to find the appropriate dose, followed by further dose evaluation. The treatment is delivered subcutaneously at specified doses on specified days, monitored closely for safety and immune response. During the study, participants undergo regular assessments including blood tests to measure drug levels, immune cell changes, and anti-drug antibodies. Safety monitoring continues throughout the 48-week period, with researchers tracking disease activity and any adverse effects. The total study duration extends until March 2029, allowing long-term evaluation of treatment impact.

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjgren Syndrome pSS, a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mgkg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjgrens disease, with safety and immune response also closely observed until Day 211.

Delirium is a clinical syndrome marked by sudden attention problems, changes in consciousness, and fluctuating thinking abilities. It often occurs in hospitalized elderly patients after surgery, especially in intensive care units, leading to worse recovery, higher death rates, longer hospital stays, and increased healthcare costs. This research investigates how oral health, particularly a condition called oral frailty, may be linked to postoperative delirium and cognitive decline in surgical patients. The study observes surgical patients who have or do not have oral frailty before elective cardiac or thoracic surgery requiring endotracheal intubation. Oral frailty is assessed using a specific scale before surgery. Participants are grouped based on the presence or absence of oral frailty to explore its relationship with delirium and other postoperative outcomes. Participants will be monitored for delirium within one week after surgery. Other evaluations include swallowing ability, appetite, and blood protein levels measured within 48 hours after removing the breathing tube, as well as routine postoperative blood tests during the first week. The study aims to understand connections between oral health and cognitive changes after surgery, potentially guiding future prevention strategies. Participation lasts throughout the perioperative and early postoperative period.

Researchers are investigating oral disorders in extremely premature infants born before 29 weeks, focusing on the age at which these infants achieve full oral feeding without the need for tube feeding. The study aims to understand the development of oral skills in this population, as oral disorders can lead to delayed feeding autonomy and longer hospital stays, impacting psychomotor and cognitive development. It also seeks to identify risk factors for delayed oral feeding and calculate the incidence of oral feeding disorders up to 24 months of age. The study monitors infants admitted to a neonatal unit where a daily tactile stimulation protocol of orality is applied by nurses and physiotherapists to support the development of oral skills. This protocol involves stroking cheeks and peri-oral and intra-oral areas to encourage oral feeding autonomy. The study is observational and focuses on infants born between 2018 and 2021 who received this care approach during their hospital stay. Participants will be followed from birth until they reach full oral feeding autonomy, with the main measurement being the corrected gestational age at this time, observed up to two months. Researchers will also analyze risk factors for delayed oral feeding and track oral feeding disorders over a longer term. Data collection includes monitoring feeding progress and hospital discharge details, with participant involvement ending when oral feeding autonomy is achieved or after 24 months for disorder incidence assessment.