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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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
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Kurz gefasst

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 Teilnehmende gesucht103 Studienzentren20 Länder

Kategorien

Nephrologie und Urologie58%Immunologie und Rheumatologie27%Dermatologie8%Geburtshilfe und Gynäkologie8%

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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.

Zusammenfassung

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.

Erkrankungen

  • Lupus Nephritis

Eignung

GeschlechtAlle
Alter18 Years – 100 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 2
ZuteilungRandomisiert
InterventionsmodellSEQUENTIAL
Primäres ZielTREATMENT
VerblindungQUADRUPLE (4)
Teilnahme240 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Novartis Pharmaceuticals Sponsor

Studienarme und Interventionen

  • 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

Interventionen

  • Arzneimittel Iptacopan (part 1)

    Taken for 52 Weeks

  • Arzneimittel Iptacopan (part 2)

    Taken for 52 Weeks

  • Arzneimittel Iptacopan + placebo

    Taken for 52 Weeks

  • Arzneimittel Placebo + standard of care

    Taken for 52 Weeks

Endpunkte

  1. Primärer Endpunkt

    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.

    Zeitrahmen Baseline and week 24

  2. Sekundärer Endpunkt

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

    Measure disease activity

    Zeitrahmen Weeks 24 and 52

  3. Sekundärer Endpunkt

    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

    Zeitrahmen Baseline, week 24, week 52

  4. Sekundärer Endpunkt

    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

    Zeitrahmen Baseline, week 24 week 52

  5. Sekundärer Endpunkt

    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)

    Zeitrahmen Baseline week 24

  6. Sekundärer Endpunkt

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    Zeitrahmen Weeks 24 and 52

  7. Sekundärer Endpunkt

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

    Measure disease activity in SLE

    Zeitrahmen Weeks 24 and 52

  8. Sekundärer Endpunkt

    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

    Zeitrahmen Week 24 and Week 52

Daten

Startdatum10. August 2022 (tatsächlich)
Primärer Abschluss19. März 2026 (tatsächlich)
Abschluss28. September 2028 (geschätzt)
Erstveröffentlichung7. März 2022 (tatsächlich)
Zuletzt aktualisiert30. Juli 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtJuli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

39 Studienzentren rekrutieren

Argentina

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteRosarioSanta Fe ProvinceZurückgezogen
Novartis Investigative SiteSan LuisZurückgezogen
Novartis Investigative SiteSanta FeAktiv, rekrutiert nicht

Brazil

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteBarretosSão PauloAktiv, rekrutiert nicht
Novartis Investigative SiteBelo HorizonteMinas GeraisAbgeschlossen
Novartis Investigative SiteJuiz de ForaMinas GeraisAktiv, rekrutiert nicht
Novartis Investigative SiteSalvadorEstado de BahiaAktiv, rekrutiert nicht
Novartis Investigative SiteSalvadorAktiv, rekrutiert nicht
Novartis Investigative SiteSão PauloSão PauloAktiv, rekrutiert nicht
Novartis Investigative SiteSão PauloSão PauloAktiv, rekrutiert nicht
Novartis Investigative SiteSão PauloSão PauloAbgeschlossen

China

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteBeijingAktiv, rekrutiert nicht
Novartis Investigative SiteNanningGuangxiAbgeschlossen
Novartis Investigative SiteShenyangLiaoningRekrutiert
Novartis Investigative SiteShenzhenRekrutiert
Novartis Investigative SiteWuhanHubeiRekrutiert
Novartis Investigative SiteYinchuanNingxiaAktiv, rekrutiert nicht

Colombia

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteBarranquillaAtlánticoAktiv, rekrutiert nicht
Novartis Investigative SiteBogotaCundinamarcaAktiv, rekrutiert nicht
Novartis Investigative SiteBucaramangaSantander DepartmentAktiv, rekrutiert nicht
Novartis Investigative SiteMonteríaAbgeschlossen

France

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteMarseilleAbgeschlossen
Novartis Investigative SiteNantesRekrutiert
Novartis Investigative SiteParisZurückgezogen
Novartis Investigative SiteStrasbourgZurückgezogen

Germany

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteBerlinZurückgezogen
Novartis Investigative SiteBraunschweigLower SaxonyRekrutiert
Novartis Investigative SiteCologneNorth Rhine-WestphaliaRekrutiert
Novartis Investigative SiteFrankfurt am MainHesseZurückgezogen
Novartis Investigative SiteLudwigshafenGermanyZurückgezogen
Novartis Investigative SiteMainzRekrutiert
Novartis Investigative SiteMunichBavariaZurückgezogen

Hong Kong

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteHong KongHong KongAktiv, rekrutiert nicht

Hungary

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteBudapestRekrutiert
Novartis Investigative SiteDebrecenHajdu Bihar MegyeRekrutiert
Novartis Investigative SiteSzegedAktiv, rekrutiert nicht

India

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteAhmedabadGujaratZurückgezogen
Novartis Investigative SiteHyderabadTelanganaRekrutiert
Novartis Investigative SiteKozhikodeKeralaRekrutiert
Novartis Investigative SiteLucknowUttar PradeshRekrutiert
Novartis Investigative SiteNew DelhiNational Capital Territory of DelhiRekrutiert
Novartis Investigative SitePuducherryZurückgezogen
Novartis Investigative SiteVelloreTamil NaduZurückgezogen

Israel

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteAshkelonZurückgezogen
Novartis Investigative SiteJerusalemZurückgezogen
Novartis Investigative SiteRamat GanZurückgezogen

Malaysia

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteKuantanPahangRekrutiert
Novartis Investigative SiteSelangor Darul EhsanRekrutiert
Novartis Investigative SiteTaipingPerakRekrutiert

Mexico

EinrichtungStadtBundesland oder RegionStatus
Novartis Investigative SiteAguascalientesAbgeschlossen

53 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

Register: ClinicalTrials.gov · NCT########

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