Ensayo clínico de fase 2, adaptativo, aleatorizado, doble ciego, de exploración de dosis, de grupos paralelos, controlado con placebo y multicéntrico para evaluar la eficacia, seguridad y tolerabilidad de LNP023 en combinación con el tratamiento estándar con y sin corticosteroides orales en pacientes con nefritis lúpica activa clase III-IV, +/- V

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05268289Tipo: INTERVENTIONALInicio: 10 de ago de 2022Fin estimado: 28 de sept de 2028

Resumen

El objetivo general de este estudio en dos partes es evaluar la eficacia, seguridad y tolerabilidad de iptacopan (LNP023) en adición al tratamiento estándar.

Descripción detallada

El objetivo general de este estudio en dos partes es evaluar la eficacia, seguridad y tolerabilidad de iptacopan (LNP023) en adición al tratamiento estándar.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.
Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.
eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.
First presentation or flare of lupus nephritis.

Criterios de exclusión

Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.
Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.
Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.
Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.
Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)

Intervenciones

drug

Iptacopan (part 1)

Taken for 52 Weeks

drug

Iptacopan (part 2)

Taken for 52 Weeks

drug

Placebo + standard of care

Taken for 52 Weeks

drug

Iptacopan + placebo

Taken for 52 Weeks

Ubicaciones

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

WITHDRAWN

Novartis Investigative Site

San Luis, Argentina

WITHDRAWN

Novartis Investigative Site

Santa Fe, Argentina

ACTIVE_NOT_RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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