Villeurbanne

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III study aims to better understand the impact of trontinemab on cognitive decline and daily functioning in this population. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be assigned to receive either intravenous trontinemab or an intravenous placebo. The treatment period lasts up to 72 weeks, during which participants receive infusions as scheduled. Assessments include brain imaging such as amyloid and tau PET scans, cerebrospinal fluid and blood biomarker collection, and cognitive testing. The study also monitors safety through tracking adverse events, infusion-related reactions, and anti-drug antibodies. Participants will attend visits for evaluations including clinical dementia rating, cognitive scales like MMSE and ADAS-Cog-13, and daily living activities assessments. Safety monitoring involves MRI scans and lab tests. The primary outcome measured is the change in Clinical Dementia Rating, Sum of Boxes CDR-SB, from baseline to Week 72. The total duration of participation extends through the 72-week treatment and assessment period, with ongoing safety evaluations.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.

This research aims to evaluate the long-term efficacy and safety of a combined formulation of xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for treating agitation in participants with Alzheimers Disease. The study focuses on individuals who have completed prior parent studies CN012-0023 or CN012-0024 and seeks to understand treatment effects over an extended period. Participants will receive specified doses of KarXT and KarX-EC on designated days as part of this single-group, non-randomized study. The treatment phase lasts up to approximately 30 weeks, during which the combined drugs are administered and monitored for safety and effectiveness related to agitation management in Alzheimers Disease. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Assessments include tracking adverse events, serious adverse events, changes in vital signs, laboratory evaluations, electrocardiograms, cognitive function tests like the Mini-mental State Examination and ADAS-Cog-13, as well as symptom severity scales. Caregiver involvement is required to provide support and facilitate study participation. The total study duration extends up to about 30 weeks with ongoing safety and efficacy evaluations.

Researchers are studying the amount and impact of informal care provided by family members or caregivers to patients with Alzheimers disease, particularly at different stages of the condition. This research focuses on patients aged 60 and older diagnosed with dementia due to clinically probable Alzheimers disease, who have varying degrees of cognitive decline as measured by the Mini-Mental State Evaluation MMSE. The study aims to understand how cognitive decline, loss of autonomy, comorbidities, behavioral issues, and caregiver burden influence the use and cost of informal care. The study involves patients from Charpennes Hospital who are part of the MEM-AURA cohort, all accompanied by a caregiver. Researchers collect data using the Ressources Utilisation in Dementia RUD questionnaire, which gathers information on the use of services available to dementia patients. The primary focus is on measuring informal care costs at the start of the study or within 15 days after inclusion. Participants will be involved through their inclusion in the cohort and completion of questionnaires about care resources and costs. Researchers will assess the economic burden of informal care and analyze the clinical factors affecting it in Alzheimers patients. The study will track informal care costs as the main outcome, while safety and withdrawal criteria are monitored throughout the study period, which starts in September 2025 and ends in September 2027.