Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition.
During the study, the following assessments will be performed and samples will be collected

开始日期2025-04-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

NCT06447480

/ Not yet recruiting临床3期IIT

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

开始日期2025-03-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

NCT06779305

/ Not yet recruitingN/AIIT

Minimally Invasive Procedure Versus Conservative Treatment in the Management of Calcaneal Joint Fractures

Calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. Traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. However, open surgery has a high complication rate, including issues with wound healing. Recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. This study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. The goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. Thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.

开始日期2025-01-16

申办/合作机构

Centre Hospitalier Universitaire de Nice

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2025-12-01·Techniques in Coloproctology

Urge fecal incontinence: are intramural rectal injections of botulinum toxin a long-term treatment option?

Article

作者: Baumstarck, Karine ; Vitton, Véronique ; Onana Ndong, Philippe

BACKGROUND AND AIMSUnsuccessful first-line conservative treatments for managing fecal incontinence (FI) lead to considering predominantly invasive options, posing challenges in terms of cost and patient acceptance of benefit/risk ratio. Recent data from a prospective randomized study have highlighted intramural rectal botulinum toxin (BoNT/A) injection as a promising minimally invasive alternative for urge FI, demonstrating efficacy at 3 months but lacking long-term evidence. This study aimed to evaluate the sustained efficacy and injection frequency of intramural rectal BoNT/A injection in the treatment of urge FI.METHODSThis retrospective monocentric study enrolled all patients who underwent intramural rectal BoNT/A injection for urge FI after failed conservative therapy or sacral neuromodulation (SNM). Injections were administered during sigmoidoscopy, delivering 200 U of BoNT/A at 10 circumferentially distributed sites. Treatment effectiveness was assessed using the Cleveland clinic incontinence score (CCS) and a visual analog scale (VAS) to measure the severity of discomfort related to episodes of fecal urgency, with reinjection performed upon symptom recurrence.RESULTSIn total, 41 patients (34 females) were included, with a median follow-up of 24.9 (range 3.2-70.3) months. Overall, 11 patients had previously failed sacral nerve stimulation. Significant reductions were observed in the CCS (median 11 versus 7, p = 0.001) and VAS symptoms (median 4, range 0-5 versus median 2, range 0-5, p = 0.001). In total, 22 patients (53%) experienced a reduction in the CCS by over 50%. The median interval between intramural rectal BoNT/A injections was 9.8 months (range 5.3-47.9 months).CONCLUSIONSThis study provides the first evidence of the sustained efficacy of intramural rectal BoNT/A injection for urge FI. Further investigations are warranted to refine patient selection and reinjection criteria, evaluate socioeconomic impacts, and compare rectal BoNT/A injection with other therapeutic modalities.

2025-01-02·Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

Treatment continuity of amyotrophic lateral sclerosis with available riluzole formulations: state of the art and current challenges in a ‘real-world’ setting

Review

作者: Pradat, Pierre-François ; Soriani, Marie-Helene ; Verschueren, Annie ; Couratier, Philippe ; Corcia, Philippe ; Guy, Nathalie

Amyotrophic lateral sclerosis (ALS) is a rare multisystem neurodegenerative disease leading to death due to respiratory failure. Riluzole was the first disease modifying treatment approved in ALS. Randomized clinical trials showed a significant benefit of riluzole on survival in the months following randomization, with a good safety profile. 'Real-world' studies suggested that the survival benefit of riluzole is substantially greater, with an extended survival ranging between 6 and 19 months. The main limiting associated adverse effects of riluzole are non-severe gastrointestinal complications and an elevation of liver enzymes, observed in 10% of patients. While different classes of drugs have been approved in some countries, riluzole remains the gold standard of therapy. Dysphagia induced by ALS is a major challenge for food intake and riluzole administration. Tablet crushing is associated with a loss of drug intake and a risk of powder aspiration, which jeopardizes the benefits of riluzole. Riluzole oral suspension (ROS) and oral film (ROF) allow riluzole intake in patients with dysphagia. Both formulations are bioequivalent to riluzole tablets with a good safety profile albeit transient oral hypoaesthesia. In case of severe dysphagia, ROS can be used with percutaneous endoscopic gastrostomy. ROF, the last approved formulation, requires low swallowing capacities and may contribute to maintain the efficacy of riluzole when tablets are inadequate according to patient's status and/or preferences. To optimize treatment continuity in newly diagnosed patients, the expected psychological impact of formulation switching that may be perceived as the sign of disease progression should be anticipated.

2025-01-01·Annals of the Rheumatic Diseases

Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial

Article

作者: Gossec, Laure ; Poiroux, Lucile ; Richez, Christophe ; Lassoued, Slim ; Jamard, Bénédicte ; Salliot, Carine ; Couture, Guillaume ; Morel, Jacques ; Saraux, Alain ; Zabraniecki, Laurent ; Flipo, René-Marc ; Nguyen, Minh ; Roux, Christian Hubert ; Boyer, Jean Frédéric ; Soubrier, Martin ; Marotte, Hubert ; Bongard, Vanina ; Gottenberg, Jacques-Eric ; Brusq, Clara ; Ruyssen-Witrand, Adeline ; Piperno, Muriel ; Constantin, Arnaud ; Degboe, Yannick ; Masson, Maëva ; Dieudé, Philippe ; Vergne-Salle, Pascale

ObjectivesTo compare two strategies—a hydrocortisone replacement strategy and a prednisone tapering strategy—for their success in glucocorticoid discontinuation in patients with rheumatoid arthritis (RA) with low disease activity (LDA).MethodsThe Strategies for glucocorticoid TApering in Rheumatoid arthritis (STAR) study was a double-blind, double-placebo randomised controlled trial including patients with RA receiving a stable dose of glucocorticoid 5 mg/day for ≥3 months and were in LDA for ≥3 months. Patients were randomly assigned in a 1:1 ratio to either replace prednisone with 20 mg/day of hydrocortisone for 3 months, then reduce to 10 mg/day for 3 months before discontinuation or to taper prednisone by 1 mg/day every month until complete discontinuation, contingent on maintaining LDA. The primary outcome was the percentage of patients achieving glucocorticoid discontinuation at 12 months. Other secondary outcomes were proportion of flares, need for additional glucocorticoid use, disease activity, patient-reported outcomes and the results of adrenocorticotropic hormone (ACTH) stimulation tests.ResultsOf the 102 patients randomised in the trial (mean age 62.4 years, 70.6% females), 53 had hydrocortisone replacement and 49 tapered prednisone. At 12 months, 29 patients (55%) in the hydrocortisone replacement group and 23 patients (47%) in the prednisone tapering group achieved glucocorticoid discontinuation (p=0.4). No difference was observed between groups in the secondary outcomes. No cases of acute adrenal insufficiency were observed; however, 17 patients still had an abnormal ACTH stimulation test at 12 months, with no differences between arms.ConclusionA hydrocortisone replacement strategy was not superior to a prednisone tapering strategy for achieving glucocorticoid discontinuation success in patients with RA in LDA.Trial registration numberNCT02997605.

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2022-11-29

·Business Wire

Surgical Devices Pipeline Report, 2022 - Includes Stages of Development, Segments, Regions & Countries, Regulatory Path and Key Companies - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Surgical Devices Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive information about the Surgical Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. Report Scope Extensive coverage of the Surgical Devices under development The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities The report reviews the major players involved in the development of Surgical Devices and list all their pipeline projects The coverage of pipeline products based on various stages of development ranging from Early Development to Approved/Issued stage The report provides key clinical trial data of ongoing trials specific to pipeline products Recent developments in the segment/industry The report enables you to: Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of Surgical Devices under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Surgical Devices Overview 3 Products under Development 3.1 Surgical Devices - Pipeline Products by Stage of Development 3.2 Surgical Devices - Pipeline Products by Segment 3.3 Surgical Devices - Pipeline Products by Territory 3.4 Surgical Devices - Pipeline Products by Regulatory Path 3.5 Surgical Devices - Pipeline Products by Estimated Approval Date 3.6 Surgical Devices - Ongoing Clinical Trials 4 Surgical Devices - Pipeline Products under Development by Companies 4.1 Surgical Devices Companies - Pipeline Products by Stage of Development 4.2 Surgical Devices - Pipeline Products by Stage of Development 5 Surgical Devices Companies and Product Overview 6 Surgical Devices - Recent Developments 7 Appendix 7.1 Methodology List of Tables Surgical Devices - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Segment Surgical Devices - Pipeline Products by Territory Surgical Devices - Pipeline Products by Regulatory Path Surgical Devices - Pipeline Products by Estimated Approval Date Surgical Devices - Ongoing Clinical Trials Surgical Devices Companies - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Stage of Development Glossary List of Figures Surgical Devices - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Segment Surgical Devices - Pipeline Products by Territory Surgical Devices - Pipeline Products by Regulatory Path Surgical Devices - Pipeline Products by Estimated Approval Date Surgical Devices - Ongoing Clinical Trials Companies Mentioned 6S Medical LLC Abbott Operations Uruguay Srl Acoustic MedSystems Inc Aesculap Inc Anastom Surgical Anchora Medical Ltd Apercure Surgical Ltd Apollo Endosurgery Inc Applied Medical Resources Corporation Apyx Medical Corp Archon Medical Technologies LLC Augusta University Baxter International Inc BioTex Inc BriteSeed BTG International Inc Carnegie Mellon University Centre Hospitalier Universitaire de Nice Charite University Hospital of Berlin Chengdu Yurui Innovation Technology Co Ltd Colospan Ltd Control Medical Technology LLC Core Essence Orthopaedics, LLC Corporis Medical Covidien Ltd CR Bard Inc Creative Balloons GmbH Cryofocus Medtech Shanghai Co Ltd CT Resources Inc Cutera Inc Cypris Medical, Inc. Dartmouth College Deep Blue Medical Advances Inc Drexel University Emblation Ltd Embricon Ltd (Inactive) Endo Tools Therapeutics SA EndoEvolution, LLC Ethicon Endo-Surgery Inc ExpandoHeat LLC Fixit Medical Ltd Fogless International AB G.I. Windows Inc Galil Medical Ltd Garantis Genicon Inc GI Windows Medical Corp Grand Valley State University H. Lee Moffitt Cancer Center & Research Institute Inc Hangzhou Kangsheng Medical Equipment Co Ltd Hannover Medical School Harvard University Hospital for Special Surgery IceCure Medical Ltd Imperial College London Indian Institute of Technology Delhi Innovex Medical Co Ltd Integra LifeSciences Holdings Corp Intuitive Surgical Inc IonMed Ltd. Jinan Micro Intelligent Technology Co Ltd Johns Hopkins University Keren Medical Ltd. LeMaitre Vascular Inc Livsmed Inc LuSeed Vascular Lymphatica Medtech SA MagniFeel Surgical Instruments Mayo Clinic Mecmaan Healthcare Ltd Medical University of South Carolina MediShield B.V. Medtronic Plc Mel Frontier Co Ltd Meta Biomed Co Ltd Michigan State University Naval Medical Research Center Next Science Ltd NorthShore University Health System NOvate Medical Technologies, LLC NoviRad Inc NovoGI LTD Novolock Ltd Novuson Surgical, Inc. Ohio State University Oklahoma State University Olympus America Inc OV World Co Ltd Pacira BioSciences Inc Parker Hannifin Corp Pavmed Inc PetVivo Holdings Inc Physcient, Inc. Polytechnic University of Catalonia Pro-Dex Inc Queen Mary University of London Ra Medical Systems Inc Ramona Optics Inc Ratner BioMedical Inc Resultados y Calidad del Sistema Sanitario Publico de Andalucia Rice University Saint Louis University Samyang Biopharmaceuticals Corp Sanovas Inc Shanghai MicroPort Medical Group Co Ltd Shanghai Shengzhe Medical Technology Co Ltd Shanghai Yichao Medical Equipment Co Ltd Silmag SA simedeq Simon Fraser University StatLink Surgical STRATA Skin Sciences Inc Stryker Corp SurgyAid, LLC Sutura Inc Teleflex Inc Tepha Inc The Feinstein Institute for Medical Research TransMed7 LLC Trinity College Dublin University of Auckland University of California University of California Davis University of California Los Angeles University of California San Diego University of Central Florida University of Chicago University of Maryland University of Maryland Baltimore University of Minnesota University of Missouri University of North Carolina University of South Florida University of Strasbourg University of Texas at Austin University of Texas Medical Branch at Galveston University of Toledo University of Utah University of Virginia US Medical Innovations LLC USGI Medical Inc Vanderbilt University Vascular Insights LLC VB Devices Vessi Medical Ltd Viveve Medical Inc Viveve, Inc. Wake Forest Baptist Medical Center Weill Cornell Medical College West Virginia University X-Biomedical Inc For more information about this report visit https://www.researchandmarkets.com/r/ekyrrp Source: GlobalData

2022-05-18

·Pm Live

Almirall and Inserm Transfert to develop innovative vitiligo treatments

Global biopharmaceutical company, Almirall, and Inserm Transfert – the private subsidiary of the French National Institute of Health and Medical Research (Inserm) – have announced plans to collaborate under a new licencing agreement. The companies will work together to advance treatment options for people living with vitiligo, develop a more in-depth understanding of dermatological diseases and allow further access to new technologies and the discovery of new therapeutic approaches. As a chronic skin condition that affects 0.5 to 2% of the worldwide population, vitiligo is associated with a loss of pigmentation and the visibility of patients’ lesions is often seen as disfiguring and a burden. As a result, patients can experience a high level of psychological impact, alongside treatment needs. Vitiligo remains a neglected market with a high unmet medical need for treatments, particularly for patients’ hands. The collaboration agreement, signed by Inserm Transfert on behalf of Inserm, Centre Hospitalier Universitaire of Nice and University of Nice Côte d’Azur, aims to identify and develop a novel class of medicines that modulate a key target involved in skin repigmentation, the Wnt pathway. According to the terms of the agreement, Almirall has received global rights to Inserm’s background patents on the use of Wnt agonists in the treatment of vitiligo. Inserm Transfert’s involvement in this deal is part of Almirall’s SHINE initiative, which was launched to drive innovation in dermatology by putting a spotlight on collaborations with centres of excellence. Examples of this have included the partnerships with the University of Dundee and the University of Michigan. Professor Thierry Passeron and his team at the Mediterranean Centre for Molecular Medicine will work with the partnership. Professor Passeron has spearheaded research in vitiligo and will combine this with Almirall's background in drug discovery to identify and develop new topical compounds for the treatment of vitiligo. Karl Ziegelbauer, chief scientific officer at Almirall, said: “Vitiligo can have a huge impact on patients' quality of life. We are pleased to announce this new collaboration with a centre of excellence such as Inserm to develop innovative treatments for this skin condition. This milestone once again demonstrates Almirall's commitment to improving the lives of patients in an underserved disease where there are still significant unmet needs.”

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