Estudio de extensión a largo plazo, de fase II, doble ciego, de rango de dosis y paralelo para evaluar la seguridad y eficacia de enpatoran en participantes con lupus eritematoso cutáneo subagudo, lupus eritematoso discoide y/o lupus eritematoso sistémico que hayan completado el tratamiento del estudio WILLOW (MS200569_0003) (WILLOW LTE)

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05540327Tipo: INTERVENTIONALInicio: 16 de sept de 2022Fin estimado: 12 de ago de 2028

Resumen

El propósito del estudio es evaluar la seguridad y la eficacia a largo plazo de M5049 administrado por vía oral en participantes con lupus eritematoso cutáneo subagudo (LECS), lupus eritematoso discoide (LED) y/o lupus eritematoso sistémico (LES) que hayan completado el período de tratamiento de 24 semanas del estudio Willow (MS200569_0003 [NCT05162586]).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 76 YearsSexo: ALL

Criterios de inclusión

Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening
Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1

Criterios de exclusión

Participants who experienced serious event(s) related to the study intervention during the WILLOW study
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization
Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
Participation in any other investigational drug study after the WILLOW study Week 24

Intervenciones

drug

M5049 low dose

Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.

drug

M5049 medium dose

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.

drug

M5049 high dose

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.

drug

Placebo

Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.

Ubicaciones

Centro de Investigaciones Medicas Mar del Plata - CIM

Buenos Aires, Argentina

CINME - Centro De Investigaciones Metabolicas

Buenos Aires, Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina

Hospital Militar Central Dr. Cosme Argerich

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata - CIM

Mar del Plata, Argentina

Instituto de Reumatologia

Mendoza, Argentina

Instituto Medico de alta Complejidad San Isidro S.A (IMAC)

San Fernando, Argentina

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, Argentina

Centro Dermatologico Schejtman

San Miguel, Argentina

PSORIAHUE-Medicina Interdisciplinar

San Miguel, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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