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- Proyectos y Estudios
- Estudio de fase III, aleatorizado, doble ciego, de grupos paralelos para evaluar la eficacia y seguridad de la administración subcutánea de depemokimab 100 mg en pacientes con rinosinusitis crónica con poliposis nasal (RSCcPN) - ANCHOR-2 (Depemokimab en Rinosinusitis Crónica)
Estudio de fase III, aleatorizado, doble ciego, de grupos paralelos para evaluar la eficacia y seguridad de la administración subcutánea de depemokimab 100 mg en pacientes con rinosinusitis crónica con poliposis nasal (RSCcPN) - ANCHOR-2 (Depemokimab en Rinosinusitis Crónica)
Datos básicos
- Código:
- 218079
- Protocolo:
- 218079
- EUDRACT:
- 2021-005055-36
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2022
- Año de finalización:
- 2025
Objetivos del proyecto
Objetivo Principal: Evaluar la eficacia de depemokimab 100 mg SC + TdR en comparación con placebo + TdR en la semana 52 en participantes con diagnóstico de RSCcPN Objetivos Secundarios: - Evaluar la eficacia de depemokimab 100 mg SC + TdR en comparación con placebo + TdR en la semana 52 en cuanto a las puntuaciones de los síntomas de rinorrea (goteo nasal) y pérdida de olfato - Evaluar la eficacia de depemokimab 100 mg SC + TdR en comparación con placebo + TdR en la semana 52 en cuanto a la puntuación de Lund Mackay en la TC - Evaluar el impacto en la calidad de vida de depemokimab 100 mg SC + TdR en comparación con placebo + TdR en la semana 52 en pacientes con diagnóstico de RSCcPN - Evaluar el impacto en el control del asma de depemokimab 100 mg SC + TdR comparado con placebo + TdR en la semana 52 en el subgrupo de participantes con asma y un diagnóstico de RSCcPN - Evaluar la eficacia de depemokimab 100 mg SC + TdR en comparación con placebo + TdR en la semana 26 en participantes con diagnóstico de RSCcPN
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Grupos
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Resultados del Ensayo Clínico
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Artificial Intelligence on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.
Prats-Climent, Joan; (...); Marti-Bonmati, Luis
Article. 10.1007/s10916-022-01836-w. 2022
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Association between upper and lower respiratory disease among patients with primary ciliary dyskinesia: an international study.
Lam, Yin Ting; (...); Goutaki, Myrofora
Article. 10.1183/23120541.00932-2023. 2024
Association between upper and lower respiratory disease in primary ciliary dyskinesia
Lam, Yin Ting; (...); Goutaki, Myrofora
Meeting Abstract. 10.1183/13993003.congress-2023.PA2765. 2023
Automatic etiological classification of stroke thrombus digital photographs using a deep learning model
Lucero-Garofano, Alvaro; (...); Manjon, Jose V.
Article. 10.3389/fneur.2025.1534845. 2025
Barbed suture pharyngoplasty in velopharyngeal complete concentric collapse: a multicentric study
Castillo-Farias, Felipe; (...); Vicini, Claudio
Article. 10.1186/s43163-022-00241-x. 2022
Cavernous Sinus Thrombosis Secondary to Streptococcus Constellatus Pharynges
Jaramillo-Angel, Natalia; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-024-04511-3. 2024
Consensus definition of sinonasal and otologic exacerbation in patients with primary ciliary dyskinesia
Goutaki, Myrofora; (...); Papon, Jean-Francois
Meeting Abstract. 10.1183/13993003.congress-2024.OA1989. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Characteristics of Otologic Disease Among Patients With Primary Ciliary Dyskinesia.
Goutaki, Myrofora; (...); Papon, Jean-Francois
Article. 10.1001/jamaoto.2023.0841. 2023
DeepCERES: A deep learning method for cerebellar lobule segmentation using ultra-high resolution multimodal MRI.
Morell-Ortega, Sergio; (...); Manjon, Jose V
Article. 10.1016/j.neuroimage.2025.121063. 2025
Definition of sinonasal and otological exacerbation in patients with primary ciliary dyskinesia: an expert consensus.
Goutaki, Myrofora; (...); Papon, Jean-Francois
Article. 10.1183/23120541.00218-2024. 2024
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Distal Access Catheter Improves Balloon Guide and Stent Retriever Thrombectomy Outcomes in Nonagenarians.
Puig, Josep; (...); Blasco, Jordi
Article. 10.1111/jon.70012. 2025
Dizziness Evaluation and Characterisation of Patients with Posterior Circulation Stroke in the Emergency De- partment; a Case Series Study
Saro-Buendia, Miguel; (...); Armengot Carceller, Miguel
Article. 10.22037/aaem.v11i1.1764. 2023
Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics
Murias, Eduardo; (...); Vega, Pedro
Article. 10.3390/jcm13113123. 2024
Evolución de la incidencia de las enfermedades infecciosas del área ORL en edad pediátrica durante la pandemia COVID-19.
Torres-García L; (...); Carceller MA
Article. 10.1016/j.otorri.2022.07.005. 2023
Evolution in the incidence of infectious diseases in the pediatric ENT area during the COVID-19 pandemic.
Torres-Garcia, Lidia; (...); Carceller MA
Article. 10.1016/j.otoeng.2022.11.007. 2022
Executive dysfunction and cortical variations among intimate partner violence perpetrators and the association with sexism.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1093/scan/nsae046. 2024
Fallopian Canal Meningocele Causing Cerebrospinal Fluid Rhinorrhoea
Saro-Buendia, Miguel; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-023-03963-3. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Giant Solitary Sinonasal Enchondroma: A Rare Case Report.
Almanzo S; (...); Armengot Carceller M
Article. 10.1007/s12070-024-04620-z. 2024
Gray matter volume differences in intimate partner violence perpetrators and its role in explaining dropout and recidivism
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1016/j.jpsychires.2024.09.019. 2024
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Labyrinthine Bifurcation of the Facial Nerve
Saro-Buendia, Miguel; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-023-03977-x. 2023
Lack of Correlation of Sinonasal and Otologic Reported Symptoms With Objective Measurements Among Patients With Primary Ciliary Dyskinesia: An International Study.
Lam YT; (...); Goutaki M
Article. 10.21053/ceo.2023.01130. 2023
Langerhans cell histiocytosis of the head and neck in the pediatric population in a tertiary center: Clinical presentation, classification and treatment.
García Díaz MP; (...); Carceller, Miguel Armengot
Article. 10.1016/j.ijporl.2022.111073. 2022
Management of iodine contrast induced salivary gland swelling (sialadenitis): experiences from an observational study.
Saro-Buendía M; (...); Armengot Carceller M
Article. 10.1080/00016489.2022.2162121. 2023
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Molecular and Clinical Predictors of Quality of Life in Chronic Rhinosinusitis with Nasal Polyps.
Brunet, Aina; (...); Armengot, Miguel
Article. 10.3390/jcm12041391. 2023
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases
Nadal, E.; (...); Bruna, J.
Meeting Abstract. 2022
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
Odontogenic maxillary sinusitis and fungus ball development secondary to a dental root retained for more than 25 years. A case report.
Borrás-Ferreres J, Armengot-Carceller M, Gay-Escoda C
Case Reports. 10.4317/jced.59663. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Otologic features in patients with Primary Ciliary Dyskinesia - an EPIC-PCD study
Goutaki, M.; (...); Papon, J-F
Meeting Abstract. 10.1055/s-0042-1754486. 2022
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Posterior Lingual Abscess; Report of Two Cases.
Saro-Buendia, Miguel; (...); Armengot Carceller, Miguel
Case Reports. 10.22037/aaem.v11i1.1860. 2023
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Redox Imbalance in Nasal Epithelial Cells of Primary Ciliary Dyskinesia Patients.
Reula, Ana; (...); Dasi, Francisco
Article. 10.3390/antiox13020190. 2024
Severe Hypoplasia of Paranasal Sinuses and Turbinates.
Saro-Buendia, Miguel, Gomez-Gomez, Maria Jose, Armengot-Carceller, Miguel
Article. 10.1001/jamaoto.2024.0674. 2024
Shift in the profile and prognostic implications in invasive fungal rhinosinusitis: experience of 10 years in a tertiary center
Mellidez-Acosta, Raul; (...); Garcia-Pinero, Alfonso
Article. 10.1186/s43163-024-00750-x. 2025
Sinonasal disease among patients with primary ciliary dyskinesia: an international study.
Lam YT; (...); Goutaki M
Article. 10.1183/23120541.00701-2022. 2023
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Stimulator of interferon genes-associated vasculopathy with onset in infancy (SAVI syndrome).
Saro-Buendia, M; (...); Armengot-Carceller, M
Article. 10.1016/j.anorl.2024.11.008. 2024
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of brain volume to explain autonomous imbalance during recovery from acute stress in batterers.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Letter. 10.1007/s00429-024-02772-w. 2024
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
The disease-specific clinical trial network for primary ciliary dyskinesia: PCD-CTN.
Raidt, Johanna; (...); Nielsen, Kim G.
Article. 10.1183/23120541.00139-2022. 2022
The role of intimate partner violence perpetrators' resting state functional connectivity in treatment compliance and recidivism.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Article. 10.1038/s41598-024-52443-3. 2024
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Uniparental Disomy of chromosome 16 as a cause of Primary Ciliary Dyskinesia
Carretero-Vilarroig, Lidon; (...); Jaijo, Teresa
Meeting Abstract. 2024
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023
vol2Brain: A New Online Pipeline for Whole Brain MRI Analysis
Manjón JV; (...); Coupé P
Article. 10.3389/fninf.2022.862805. 2022
When the Nose Meets the Lab: Histopathological Analysis in Chronic Rhinosinusitis with Nasal Polyps for Routine Clinical Practice.
Alobid, Isam; (...); Mullol, Joaquim
Article. 10.1007/s11882-024-01180-8. 2024