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NCT05268289ClinicalTrials.gov

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V

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En resumen

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Fase 2240 participantes buscados103 centros20 países

Categorías

Nefrología y urología58%Inmunología y reumatología27%Dermatología8%Obstetricia y ginecología8%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2022-03-07; recorded start 2022-08-10
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 103 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 240 participants (target), run at 103 sites, across 20 countries.

How this score is built
  • Enrolment23/40

    240 participants (target)

  • Site count23/25

    103 sites

  • Country count15/15

    20 countries

  • Planned duration10/10

    Planned over about 75 months

  • Sponsor scale10/10

    Novartis Pharmaceuticals has led 1,104 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Afecciones

  • Lupus Nephritis

Elegibilidad

SexoTodos
Edades18 Years – 100 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: 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. Exclusion Criteria: 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) Other protocol-defined inclusion/exclusion criteria may apply

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 2
AsignaciónAleatorizado
Modelo de intervenciónSEQUENTIAL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción240 participantes buscados

Patrocinador y colaboradores

  • Novartis Pharmaceuticals Patrocinador

Grupos e intervenciones

  • Iptacopan + standard of care (part 1)ACTIVE_COMPARATOR

    Iptacopan + standard of care

  • Placebo matching iptacopan + standard of care (part 1)PLACEBO_COMPARATOR

    Placebo matching iptacopan standard of care

  • Iptacopan + standard of care (part 2)ACTIVE_COMPARATOR

    Iptacopan + standard of care

  • Iptacopan + placebo (part 2)ACTIVE_COMPARATOR

    Iptacopan + placebo standard of care

  • Placebo matching iptacopan + standard of care (part 2)ACTIVE_COMPARATOR

    Placebo matching iptacopan + standard of care

Intervenciones

  • Fármaco Iptacopan (part 1)

    Taken for 52 Weeks

  • Fármaco Iptacopan (part 2)

    Taken for 52 Weeks

  • Fármaco Iptacopan + placebo

    Taken for 52 Weeks

  • Fármaco Placebo + standard of care

    Taken for 52 Weeks

Variables de resultado

  1. Variable de resultado principal

    Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

    Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.

    Plazo Baseline and week 24

  2. Variable de resultado secundaria

    Change from baseline in BILAG-2004 score at weeks 24 and 52

    Measure disease activity

    Plazo Weeks 24 and 52

  3. Variable de resultado secundaria

    Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares

    Proportion of patients achieving complete renal response or partial renal response

    Plazo Baseline, week 24, week 52

  4. Variable de resultado secundaria

    Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24

    Frequency of renal flares between weeks 24 and 52

    Plazo Baseline, week 24 week 52

  5. Variable de resultado secundaria

    Log-transformed ratio to baseline of 24h UPCR at week 24

    Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatinine ratio value will based on two 24 urine collections sampled within 10 days before the respective study visit)

    Plazo Baseline week 24

  6. Variable de resultado secundaria

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    Plazo Weeks 24 and 52

  7. Variable de resultado secundaria

    Change from baseline in SLEDAI-2K score at weeks 24 and 52

    Measure disease activity in SLE

    Plazo Weeks 24 and 52

  8. Variable de resultado secundaria

    Time-to-Complete Renal Response (CRR) based on first morning void(FMV) urine samples

    Measurement of time to complete renal response based on urine samples

    Plazo Week 24 and Week 52

Fechas

Fecha de inicio10 de agosto de 2022 (real)
Finalización principal19 de marzo de 2026 (real)
Finalización28 de septiembre de 2028 (estimada)
Primera publicación7 de marzo de 2022 (real)
Última actualización30 de julio de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjulio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

39 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteRosarioSanta Fe ProvinceRetirado
Novartis Investigative SiteSan LuisRetirado
Novartis Investigative SiteSanta FeActivo, sin reclutar

Brazil

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteBarretosSão PauloActivo, sin reclutar
Novartis Investigative SiteBelo HorizonteMinas GeraisCompletado
Novartis Investigative SiteJuiz de ForaMinas GeraisActivo, sin reclutar
Novartis Investigative SiteSalvadorEstado de BahiaActivo, sin reclutar
Novartis Investigative SiteSalvadorActivo, sin reclutar
Novartis Investigative SiteSão PauloSão PauloActivo, sin reclutar
Novartis Investigative SiteSão PauloSão PauloActivo, sin reclutar
Novartis Investigative SiteSão PauloSão PauloCompletado

China

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteBeijingActivo, sin reclutar
Novartis Investigative SiteNanningGuangxiCompletado
Novartis Investigative SiteShenyangLiaoningEn reclutamiento
Novartis Investigative SiteShenzhenEn reclutamiento
Novartis Investigative SiteWuhanHubeiEn reclutamiento
Novartis Investigative SiteYinchuanNingxiaActivo, sin reclutar

Colombia

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteBarranquillaAtlánticoActivo, sin reclutar
Novartis Investigative SiteBogotaCundinamarcaActivo, sin reclutar
Novartis Investigative SiteBucaramangaSantander DepartmentActivo, sin reclutar
Novartis Investigative SiteMonteríaCompletado

France

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteMarseilleCompletado
Novartis Investigative SiteNantesEn reclutamiento
Novartis Investigative SiteParisRetirado
Novartis Investigative SiteStrasbourgRetirado

Germany

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteBerlinRetirado
Novartis Investigative SiteBraunschweigLower SaxonyEn reclutamiento
Novartis Investigative SiteCologneNorth Rhine-WestphaliaEn reclutamiento
Novartis Investigative SiteFrankfurt am MainHesseRetirado
Novartis Investigative SiteLudwigshafenGermanyRetirado
Novartis Investigative SiteMainzEn reclutamiento
Novartis Investigative SiteMunichBavariaRetirado

Hong Kong

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteHong KongHong KongActivo, sin reclutar

Hungary

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteBudapestEn reclutamiento
Novartis Investigative SiteDebrecenHajdu Bihar MegyeEn reclutamiento
Novartis Investigative SiteSzegedActivo, sin reclutar

India

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteAhmedabadGujaratRetirado
Novartis Investigative SiteHyderabadTelanganaEn reclutamiento
Novartis Investigative SiteKozhikodeKeralaEn reclutamiento
Novartis Investigative SiteLucknowUttar PradeshEn reclutamiento
Novartis Investigative SiteNew DelhiNational Capital Territory of DelhiEn reclutamiento
Novartis Investigative SitePuducherryRetirado
Novartis Investigative SiteVelloreTamil NaduRetirado

Israel

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteAshkelonRetirado
Novartis Investigative SiteJerusalemRetirado
Novartis Investigative SiteRamat GanRetirado

Malaysia

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteKuantanPahangEn reclutamiento
Novartis Investigative SiteSelangor Darul EhsanEn reclutamiento
Novartis Investigative SiteTaipingPerakEn reclutamiento

Mexico

CentroCiudadEstado o regiónEstado
Novartis Investigative SiteAguascalientesCompletado

En el registro figuran 53 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05268289