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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati103 centri20 paesi

Categorie

Nefrologia e urologia58%Immunologia e reumatologia27%Dermatologia8%Ostetricia e ginecologia8%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Lupus Nephritis

Idoneità

SessoTutti
Età18 Years – 100 Years
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 2
AssegnazioneRandomizzata
Modello di interventoSEQUENTIAL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento240 partecipanti ricercati

Sponsor e collaboratori

  • Novartis Pharmaceuticals Sponsor

Bracci e interventi

  • 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

Interventi

  • Farmaco Iptacopan (part 1)

    Taken for 52 Weeks

  • Farmaco Iptacopan (part 2)

    Taken for 52 Weeks

  • Farmaco Iptacopan + placebo

    Taken for 52 Weeks

  • Farmaco Placebo + standard of care

    Taken for 52 Weeks

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale Baseline and week 24

  2. Esito secondario

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

    Measure disease activity

    Orizzonte temporale Weeks 24 and 52

  3. Esito secondario

    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

    Orizzonte temporale Baseline, week 24, week 52

  4. Esito secondario

    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

    Orizzonte temporale Baseline, week 24 week 52

  5. Esito secondario

    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)

    Orizzonte temporale Baseline week 24

  6. Esito secondario

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    Orizzonte temporale Weeks 24 and 52

  7. Esito secondario

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

    Measure disease activity in SLE

    Orizzonte temporale Weeks 24 and 52

  8. Esito secondario

    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

    Orizzonte temporale Week 24 and Week 52

Date

Data di inizio10 agosto 2022 (effettiva)
Conclusione primaria19 marzo 2026 (effettiva)
Conclusione28 settembre 2028 (stimata)
Prima pubblicazione7 marzo 2022 (effettiva)
Ultimo aggiornamento30 luglio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaluglio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

39 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Novartis Investigative SiteRosarioSanta Fe ProvinceRitirato
Novartis Investigative SiteSan LuisRitirato
Novartis Investigative SiteSanta FeAttivo, non in reclutamento

Brazil

StrutturaCittàStato o regioneStato
Novartis Investigative SiteBarretosSão PauloAttivo, non in reclutamento
Novartis Investigative SiteBelo HorizonteMinas GeraisCompletato
Novartis Investigative SiteJuiz de ForaMinas GeraisAttivo, non in reclutamento
Novartis Investigative SiteSalvadorEstado de BahiaAttivo, non in reclutamento
Novartis Investigative SiteSalvadorAttivo, non in reclutamento
Novartis Investigative SiteSão PauloSão PauloAttivo, non in reclutamento
Novartis Investigative SiteSão PauloSão PauloAttivo, non in reclutamento
Novartis Investigative SiteSão PauloSão PauloCompletato

China

StrutturaCittàStato o regioneStato
Novartis Investigative SiteBeijingAttivo, non in reclutamento
Novartis Investigative SiteNanningGuangxiCompletato
Novartis Investigative SiteShenyangLiaoningIn reclutamento
Novartis Investigative SiteShenzhenIn reclutamento
Novartis Investigative SiteWuhanHubeiIn reclutamento
Novartis Investigative SiteYinchuanNingxiaAttivo, non in reclutamento

Colombia

StrutturaCittàStato o regioneStato
Novartis Investigative SiteBarranquillaAtlánticoAttivo, non in reclutamento
Novartis Investigative SiteBogotaCundinamarcaAttivo, non in reclutamento
Novartis Investigative SiteBucaramangaSantander DepartmentAttivo, non in reclutamento
Novartis Investigative SiteMonteríaCompletato

France

StrutturaCittàStato o regioneStato
Novartis Investigative SiteMarseilleCompletato
Novartis Investigative SiteNantesIn reclutamento
Novartis Investigative SiteParisRitirato
Novartis Investigative SiteStrasbourgRitirato

Germany

StrutturaCittàStato o regioneStato
Novartis Investigative SiteBerlinRitirato
Novartis Investigative SiteBraunschweigLower SaxonyIn reclutamento
Novartis Investigative SiteCologneNorth Rhine-WestphaliaIn reclutamento
Novartis Investigative SiteFrankfurt am MainHesseRitirato
Novartis Investigative SiteLudwigshafenGermanyRitirato
Novartis Investigative SiteMainzIn reclutamento
Novartis Investigative SiteMunichBavariaRitirato

Hong Kong

StrutturaCittàStato o regioneStato
Novartis Investigative SiteHong KongHong KongAttivo, non in reclutamento

Hungary

StrutturaCittàStato o regioneStato
Novartis Investigative SiteBudapestIn reclutamento
Novartis Investigative SiteDebrecenHajdu Bihar MegyeIn reclutamento
Novartis Investigative SiteSzegedAttivo, non in reclutamento

India

StrutturaCittàStato o regioneStato
Novartis Investigative SiteAhmedabadGujaratRitirato
Novartis Investigative SiteHyderabadTelanganaIn reclutamento
Novartis Investigative SiteKozhikodeKeralaIn reclutamento
Novartis Investigative SiteLucknowUttar PradeshIn reclutamento
Novartis Investigative SiteNew DelhiNational Capital Territory of DelhiIn reclutamento
Novartis Investigative SitePuducherryRitirato
Novartis Investigative SiteVelloreTamil NaduRitirato

Israel

StrutturaCittàStato o regioneStato
Novartis Investigative SiteAshkelonRitirato
Novartis Investigative SiteJerusalemRitirato
Novartis Investigative SiteRamat GanRitirato

Malaysia

StrutturaCittàStato o regioneStato
Novartis Investigative SiteKuantanPahangIn reclutamento
Novartis Investigative SiteSelangor Darul EhsanIn reclutamento
Novartis Investigative SiteTaipingPerakIn reclutamento

Mexico

StrutturaCittàStato o regioneStato
Novartis Investigative SiteAguascalientesCompletato

Nella scheda del registro sono indicati altri 53 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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