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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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.

Phase 2240 participants recherchés103 sites20 pays

Catégories

Néphrologie et urologie58%Immunologie et rhumatologie27%Dermatologie8%Obstétrique et gynécologie8%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Lupus Nephritis

Éligibilité

SexeTous
Âges18 Years – 100 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2
RépartitionRandomisée
Modèle d'interventionSEQUENTIAL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement240 participants recherchés

Promoteur et collaborateurs

  • Novartis Pharmaceuticals Promoteur

Groupes et interventions

  • 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

Interventions

  • Médicament Iptacopan (part 1)

    Taken for 52 Weeks

  • Médicament Iptacopan (part 2)

    Taken for 52 Weeks

  • Médicament Iptacopan + placebo

    Taken for 52 Weeks

  • Médicament Placebo + standard of care

    Taken for 52 Weeks

Critères de jugement

  1. Critère de jugement 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.

    Délai Baseline and week 24

  2. Critère de jugement secondaire

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

    Measure disease activity

    Délai Weeks 24 and 52

  3. Critère de jugement secondaire

    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

    Délai Baseline, week 24, week 52

  4. Critère de jugement secondaire

    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

    Délai Baseline, week 24 week 52

  5. Critère de jugement secondaire

    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)

    Délai Baseline week 24

  6. Critère de jugement secondaire

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    Délai Weeks 24 and 52

  7. Critère de jugement secondaire

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

    Measure disease activity in SLE

    Délai Weeks 24 and 52

  8. Critère de jugement secondaire

    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

    Délai Week 24 and Week 52

Dates

Date de début10 août 2022 (réelle)
Achèvement principal19 mars 2026 (réelle)
Achèvement28 septembre 2028 (estimée)
Première publication7 mars 2022 (réelle)
Dernière mise à jour30 juillet 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

39 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteRosarioSanta Fe ProvinceRetiré
Novartis Investigative SiteSan LuisRetiré
Novartis Investigative SiteSanta FeActif, sans recrutement

Brazil

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteBarretosSão PauloActif, sans recrutement
Novartis Investigative SiteBelo HorizonteMinas GeraisTerminé
Novartis Investigative SiteJuiz de ForaMinas GeraisActif, sans recrutement
Novartis Investigative SiteSalvadorEstado de BahiaActif, sans recrutement
Novartis Investigative SiteSalvadorActif, sans recrutement
Novartis Investigative SiteSão PauloSão PauloActif, sans recrutement
Novartis Investigative SiteSão PauloSão PauloActif, sans recrutement
Novartis Investigative SiteSão PauloSão PauloTerminé

China

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteBeijingActif, sans recrutement
Novartis Investigative SiteNanningGuangxiTerminé
Novartis Investigative SiteShenyangLiaoningEn recrutement
Novartis Investigative SiteShenzhenEn recrutement
Novartis Investigative SiteWuhanHubeiEn recrutement
Novartis Investigative SiteYinchuanNingxiaActif, sans recrutement

Colombia

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteBarranquillaAtlánticoActif, sans recrutement
Novartis Investigative SiteBogotaCundinamarcaActif, sans recrutement
Novartis Investigative SiteBucaramangaSantander DepartmentActif, sans recrutement
Novartis Investigative SiteMonteríaTerminé

France

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteMarseilleTerminé
Novartis Investigative SiteNantesEn recrutement
Novartis Investigative SiteParisRetiré
Novartis Investigative SiteStrasbourgRetiré

Germany

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteBerlinRetiré
Novartis Investigative SiteBraunschweigLower SaxonyEn recrutement
Novartis Investigative SiteCologneNorth Rhine-WestphaliaEn recrutement
Novartis Investigative SiteFrankfurt am MainHesseRetiré
Novartis Investigative SiteLudwigshafenGermanyRetiré
Novartis Investigative SiteMainzEn recrutement
Novartis Investigative SiteMunichBavariaRetiré

Hong Kong

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteHong KongHong KongActif, sans recrutement

Hungary

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteBudapestEn recrutement
Novartis Investigative SiteDebrecenHajdu Bihar MegyeEn recrutement
Novartis Investigative SiteSzegedActif, sans recrutement

India

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteAhmedabadGujaratRetiré
Novartis Investigative SiteHyderabadTelanganaEn recrutement
Novartis Investigative SiteKozhikodeKeralaEn recrutement
Novartis Investigative SiteLucknowUttar PradeshEn recrutement
Novartis Investigative SiteNew DelhiNational Capital Territory of DelhiEn recrutement
Novartis Investigative SitePuducherryRetiré
Novartis Investigative SiteVelloreTamil NaduRetiré

Israel

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteAshkelonRetiré
Novartis Investigative SiteJerusalemRetiré
Novartis Investigative SiteRamat GanRetiré

Malaysia

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteKuantanPahangEn recrutement
Novartis Investigative SiteSelangor Darul EhsanEn recrutement
Novartis Investigative SiteTaipingPerakEn recrutement

Mexico

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteAguascalientesTerminé

53 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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