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Estudio de fase III multicéntrico, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia, seguridad y tolerabilidad de remibrutinib (LOU064) durante 52 semanas en pacientes adultos con urticaria crónica espontánea inadecuadamente controlados con antihistamínicos H1.

Estudio de fase III multicéntrico, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia, seguridad y tolerabilidad de remibrutinib (LOU064) durante 52 semanas en pacientes adultos con urticaria crónica espontánea inadecuadamente controlados con antihistamínicos H1.

Dades bàsiques

Protocol:: CLOU064A2301
EURDRACT:: 2021-000471-37
NCT:
Centre:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:: 2022
Any de finalització:: 2024

ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Demostrar que remibrutinib es superior a placebo en la UCE en relación con el cambio respecto a la basal en la puntuación semanal de la actividad de la urticaria (UAS7) (en la puntuación semanal de la intensidad del picor [ISS7] y la puntuación semanal de la intensidad de los habones [HSS7] para el segundo escenario de la variable principal) en la semana 12. Objetivos Secundarios: Demostrar que: remibrutinib es superior a placebo en UCE en relación con el cambio respecto a la basal en UAS7 en la sem 12 (en escenario 2); una mayor proporción de participantes tratados con remibrutinib en comparación con los participantes tratados con placebo en la semana 12: alcanzan una UAS7 =6 y la ausencia total de habones y picor (UAS7 = 0); superioridad en los pacientes tratados con remibrutinib en comparación con los tratados con placebo en la sem 12 (escenario 1) con respecto a: reducción respecto a la basal en ISS7 y en HSS7; una mayor proporción de participantes tratados con remibrutinib en comparación con pacientes tratados con placebo: alcanzan UAS=/<6 en la sem 2 y un DLQI = 0-1 en la sem 12; los pacientes tratados con remibrutinib en compración con los participantes tratados conplacebo en la sem 12: mantienen un control de la actividad de la enfermedad (UAS7 =/<6) durante más semanas y presentan más semanas sin angioedemas; la eficacia y la tolerabilidad

Documents

No hi ha documents

Participants

Antonio Javier Sahuquillo Torralba

Investigador Colaborador
Begoña Escutia Muñoz

Investigador Colaborador
Rafael Botella Estrada

Investigador Colaborador
Mercedes Rodríguez Serna

Investigador Principal
José Luis Poveda Andrés

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Verónica Massó López

Data Manager / Study Coordinator
Guillermo Bargues Navarro

Data Manager / Study Coordinator

Grups d'Investigació

Farmacogenética

Investigador Principal

María José Herrero Cervera
Dermatología y Regeneración Tisular

Leader

Rafael Botella Estrada
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco

Finançadors - Promotors

NOVARTIS FARMACEUTICA, S.A.

Resultats de l'Assaig Clínic

Publicacions en Revistes 112

"Phytophotodermatitis as a clinical problem and as a therapeutic option: case report and review of the literature".

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1016/j.pdpdt.2023.103304. 2023

[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

[[Translated article]]Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).

Couselo-Rodríguez C; (...); Flórez Á

Article. 10.1016/j.ad.2023.07.028. 2024

[[Translated article]]Epidemiological, Clinical, and Allergic Profile of Psoriatic Patients. Evaluation of the Spanish Registry of Contact Dermatitis and Cutaneous Allergy (REIDAC).

Verdaguer-Faja, J.; (...); Carrascosa, J. M.

Article. 10.1016/j.ad.2024.04.013. 2024

[Translated article] Four-year Epidemiological Surveillance of the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy: Current Situation and Trends.

Tous-Romero F; (...); Ortiz-de Frutos J

Article. 10.1016/j.ad.2024.02.006. 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] Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer - Basal Cell Carcinoma or Squamous Cell Carcinoma - Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study.

Minano Medrano, R.; (...); Garcia-Doval, I

Article. 10.1016/j.ad.2022.01.035. 2022

Clinicopathological characteristics of cutaneous and mucocutaneous leishmaniasis in patients treated with TNF-alpha inhibitors.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007. 2023

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

Dermatologic consultations for patients hospitalized in non-dermatologic wards: results of a 384-patient cross-sectional study from a tertiary referral hospital.

Mansilla-Polo, M; (...); Botella-Estrada, R

Case Reports. 10.1016/j.ad.2023.11.021. 2023

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

Development and validation of a model to predict complex Mohs Micrographic Surgery in clinical practice: REGESMOSH scale.

Montero-Vilchez, Trinidad R.; (...); Sanmartin-Jimenez, Onofre

Article. 10.1111/jdv.19056. 2023

Differences in epidemiology, comorbidities and treatment choice between plaque psoriasis and pustular psoriasis: results from the Biobadaderm registry.

Ruiz Genao, Diana P.; (...); Garcia-Doval, Ignacio

Letter. 10.1111/bjd.21763. 2022

Does hyaluronidase injected in periocular area change skin ultrastructure?: Standardized in vitro analysis

Aguilar-González M; (...); Pérez-López M

Article. 10.1111/jocd.15014. 2022

Dose reduction is a feasible strategy in patients with plaque psoriasis who achieve sustained response with secukinumab: a retrospective, multicenter cohort study in daily practice setting

Daudén E; (...); Llamas-Velasco M

Article. 10.1111/ijd.16915. 2024

Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: a Spanish multicenter cohort study

Lasheras-Pérez MA; (...); Rodríguez-Serna M

Article. 10.1111/ijd.17030. 2024

Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study.

Phan, Duc Binh; (...); Yiu ZZN

Article. 10.1136/bmjopen-2023-075197. 2023

Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).

Rodriguez, C Couselo; (...); Florez, A.

Article. 10.1016/j.ad.2023.07.014. 2023

Drug survival of adalimumab biosimilars in real-world treatment of psoriasis: A Spanish multicenter study

Lopez-Ferrer, Anna; (...); Puig, Lluis

Article. 10.1111/dth.15831. 2022

Dupilumab for atopic dermatitis during pregnancy and breastfeeding: Clinical experience in 13 patients.

Escolà H; (...); Curto-Barredo L

Letter. 10.1111/jdv.19165. 2023

Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.

Sahuquillo-Torralba, A; (...); Botella-Estrada, R

Article. 10.1111/ajd.14130. 2023

Effectiveness of Secukinumab for the treatment of erythrodermic psoriasis. Multicenter study in daily practice.

Reymundo, A; (...); Dauden, E

Letter. 10.1111/jdv.19371. 2023

Effectiveness, safety and satisfaction of 1% tirbanibulin ointment in the treatment of actinic keratoses: A prospective study in real clinical practice.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ajd.14151. 2023

Emicizumab-induced photosensitivity.

Asensi Canto, Pedro; (...); Haya Guaita, Saturnino

Article. 10.1055/s-0042-1749092. 2022

Epidemiological, Clinical, and Allergic Profile of Psoriatic Patients. Evaluation of the Spanish Registry of Contact Dermatitis and Cutaneous Allergy (REIDAC).

Verdaguer-Faja J; (...); Carrascosa JM

Article. 10.1016/j.ad.2024.02.009. 2024

Erythema Elevatum Diutinum.

Mansilla-Polo M, Botella-Estrada R

Article. 10.1016/j.ad.2023.10.042. 2024

Fast and sustained improvement of patient-reported outcomes in psoriatic patients treated with secukinumab in a daily practice setting

Chicharro, Pablo; (...); Dauden, Esteban

Article. 10.1111/dth.15653. 2022

Fatal outcome in classic Kaposi's sarcoma.

Mansilla-Polo M, Botella-Estrada R

Article. 10.1016/j.ad.2023.03.013. 2024

Four-year epidemiological surveillance of the Spanish Registry of Contact Dermatitis and Cutaneous Allergy (REIDAC): Current situation and trends.

Romero FT; (...); de Frutos JO

Article. 10.1016/j.ad.2023.10.039. 2024

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 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

Hemihypoatrophy as an extraordinary manifestation of linear morphoea.

Mansilla-Polo, Miguel, Navarro-Mira, Miguel A., Botella-Estrada, Rafael

Article. 10.1093/rap/rkac104. 2022

High adherence to secukinumab in patients with moderate to severe psoriasis: a long-term multicenter study in a daily practice setting

Martos-Cabrera, Luisa; (...); Dauden, Esteban

Letter. 10.1111/ijd.16365. 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

Identification of c.104T>G, p.Met35Arg (NM_00314.8) variant in heterozygosity in exon 2 of the PTEN gene as the Causative Factor for Cowden Syndrome: A Medical Case Study.

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1093/ced/llad344. 2023

Innovations of Spanish code of medical deontology

Lasheras-Pérez MA; (...); Unamuno Bustos B

Letter. 10.1016/j.semerg.2023.102137. 2024

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

Klinisch-pathologische Eigenschaften kutaner und mukokutaner Leishmaniose bei mit TNF-a-Inhibitoren behandelten Patienten.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007_g. 2023

Long-term follow-up of HCV-infected patients with end-stage chronic kidney disease after sustained virological response with direct-acting antiviral therapy

Martinez-Camprecios, Joan; (...); Buti, Maria

Article. 10.1016/j.gastrohep.2022.12.004. 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

Melanoma and LEOPARD Syndrome: Understanding the Role of PTPN11 Mutations in Melanomagenesis.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.2340/actadv.v104.14720. 2024

Multiple Primary Melanomas: Retrospective Review in a Tertiary Care Hospital

Palacios-Diaz RD; (...); Botella-Estrada R

Article. 10.3390/jcm11092355. 2022

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo M, Escutia-Muñoz B, Botella-Estrada R

Article. 10.1016/j.ad.2023.08.001. 2023

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo, M., Escutia-Munoz, B., Botella-Estrada, R.

Article. 10.1016/j.ad.2023.05.015. 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

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

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

Polysensitization in the Spanish Contact Dermatitis Registry (REIDAC): A 2019-2022 prospective study with cluster and network analysis.

Pesque, David; (...); Gimenez-Arnau, Ana Maria

Article. 10.1111/jdv.19934. 2024

Porto sinusoidal vascular liver disorder: natural history and long-term outcome

Magaz, Marta; (...); Garcia Pagan, Juan Carlos

Meeting Abstract. 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

Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023

Prognostic factors for satellitosis or in-transit metastasis in cutaneous squamous cell carcinoma: A multicentric cohort study.

Marti-Marti I; (...); Toll A

Article. 10.1016/j.jaad.2023.02.048. 2023

Real-life effectiveness of voxilaprevir/sofosbuvir/velpatasvir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir

Ruiz-Cobo, Juan Carlos; (...); Lens, Sabela

Meeting Abstract. 2023

Rivaroxaban improves survival and decompensation in cirrhotic patients with moderate liver dysfunction. Double-blind, placebocontrolled trial

Puente Sanchez, Angela; (...); Garcia Pagan, Juan Carlos

Meeting Abstract. 2023

Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

Lluch-Galcera, Juan Jose; (...); Garcia-Doval, Ignacio

Article. 10.1093/bjd/ljad382. 2023

Scalp Melanoma: A High-Risk Subset of Cutaneous Head and Neck Melanomas with Distinctive Clinicopathological Features.

Palacios-Diaz RD; (...); Botella-Estrada R

Article. 10.3390/jcm12247643. 2023

Secukinumab is effective and safe in the treatment of recalcitrant palmoplantar psoriasis and palmoplantar pustular psoriasis in a daily practice setting.

Reolid, Alejandra; (...); Dauden, Esteban

Article. 10.1016/j.jaad.2022.05.047. 2022

Sensitisation to textile dyes in Spain: Epidemiological situation (2019-2022).

Hernández Fernández CP; (...); Doval IG

Article. 10.1111/cod.14513. 2024

Sensitization to isothiazolinones in the Spanish Contact Dermatitis Registry (REIDAC): 2019-2021 epidemiological situation.

Hernandez Fernandez, Carlos Pelayo; (...); Garcia Doval, Ignacio

Article. 10.1111/cod.14251. 2022

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

Sodium metabisulfite a current low relevant allergen in Spain.

Sanz-Sanchez, Tatiana; (...); Borrego, Leopoldo

Letter. 10.1111/jdv.19702. 2023

Standard and Expanded Series Patch Testing Update by the Spanish Contact Dermatitis and Skin Allergy Research Group (GEIDAC).

Navarro-Triviño FJ; (...); Carlos Armario-Hita J

Article. 10.1016/j.ad.2024.03.024. 2024

Successful treatment of field of cancerization in the dorsum of the hands with 1% tirbanibulin ointment.

Abril-Perez, Carlos; (...); Botella-Estrada, Rafael

Article. 10.1093/ced/llad171. 2023

Survey to evaluate the implementation of the recommendations on the comprehensive diagnosis of viral hepatitis in a single extraction: where are we?

Cabezas, Joaquin; (...); Crespo, Javier

Meeting Abstract. 2023

SURVEY TO EVALUATE THE IMPLEMENTATION OF THE RECOMMENDATIONS ON THE COMPREHENSIVE DIAGNOSIS OF VIRAL HEPATITIS IN A SINGLE EXTRACTION: WHERE ARE WE?

Cabezas, Joaquin; (...); Crespo Garcia, Javier

Meeting Abstract. 2023

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

Estudio de fase III multicéntrico, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia, seguridad y tolerabilidad de remibrutinib (LOU064) durante 52 semanas en pacientes adultos con urticaria crónica espontánea inadecuadamente controlados con antihistamínicos H1.

Dades bàsiques

Objectius del projecte

Documents

Participants

Grups d'Investigació

Finançadors - Promotors

Resultats de l'Assaig Clínic

Campos d'Estudi

Compartir el projecte