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
ENSAYO CLÍNICO

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

Documentos

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Participantes

Grupos

Financiadores - Promotores

GLAXOSMITHKLINE SA

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

  • Open Access.

[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

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Fallopian Canal Meningocele Causing Cerebrospinal Fluid Rhinorrhoea

Saro-Buendia, Miguel; (...); Carceller, Miguel Armengot

Article. 10.1007/s12070-023-03963-3. 2023

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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