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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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.

שלב 2דרושים 240 משתתפים103 אתרים20 מדינות

קטגוריות

נפרולוגיה ואורולוגיה58%אימונולוגיה וראומטולוגיה27%רפואת עור8%מיילדות וגינקולוגיה8%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Lupus Nephritis

זכאות

מיןהכול
גילאים18 Years – 100 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 2
הקצאהאקראי
מודל ההתערבותSEQUENTIAL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 240 משתתפים

נותן חסות ושותפים

  • Novartis Pharmaceuticals נותן חסות

זרועות והתערבויות

  • 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

התערבויות

  • תרופה Iptacopan (part 1)

    Taken for 52 Weeks

  • תרופה Iptacopan (part 2)

    Taken for 52 Weeks

  • תרופה Iptacopan + placebo

    Taken for 52 Weeks

  • תרופה Placebo + standard of care

    Taken for 52 Weeks

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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.

    מסגרת זמן Baseline and week 24

  2. מדד תוצאה משני

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

    Measure disease activity

    מסגרת זמן Weeks 24 and 52

  3. מדד תוצאה משני

    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

    מסגרת זמן Baseline, week 24, week 52

  4. מדד תוצאה משני

    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

    מסגרת זמן Baseline, week 24 week 52

  5. מדד תוצאה משני

    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)

    מסגרת זמן Baseline week 24

  6. מדד תוצאה משני

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    מסגרת זמן Weeks 24 and 52

  7. מדד תוצאה משני

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

    Measure disease activity in SLE

    מסגרת זמן Weeks 24 and 52

  8. מדד תוצאה משני

    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

    מסגרת זמן Week 24 and Week 52

תאריכים

תאריך התחלה10 באוגוסט 2022 (בפועל)
סיום ראשוני19 במרץ 2026 (בפועל)
סיום28 בספטמבר 2028 (משוער)
פורסם לראשונה7 במרץ 2022 (בפועל)
עודכן לאחרונה30 ביולי 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

39 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteRosarioSanta Fe Provinceבוטל
Novartis Investigative SiteSan Luisבוטל
Novartis Investigative SiteSanta Feפעיל, ללא גיוס

Brazil

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteBarretosSão Pauloפעיל, ללא גיוס
Novartis Investigative SiteBelo HorizonteMinas Geraisהושלם
Novartis Investigative SiteJuiz de ForaMinas Geraisפעיל, ללא גיוס
Novartis Investigative SiteSalvadorEstado de Bahiaפעיל, ללא גיוס
Novartis Investigative SiteSalvadorפעיל, ללא גיוס
Novartis Investigative SiteSão PauloSão Pauloפעיל, ללא גיוס
Novartis Investigative SiteSão PauloSão Pauloפעיל, ללא גיוס
Novartis Investigative SiteSão PauloSão Pauloהושלם

China

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteBeijingפעיל, ללא גיוס
Novartis Investigative SiteNanningGuangxiהושלם
Novartis Investigative SiteShenyangLiaoningמגייס
Novartis Investigative SiteShenzhenמגייס
Novartis Investigative SiteWuhanHubeiמגייס
Novartis Investigative SiteYinchuanNingxiaפעיל, ללא גיוס

Colombia

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteBarranquillaAtlánticoפעיל, ללא גיוס
Novartis Investigative SiteBogotaCundinamarcaפעיל, ללא גיוס
Novartis Investigative SiteBucaramangaSantander Departmentפעיל, ללא גיוס
Novartis Investigative SiteMonteríaהושלם

France

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteMarseilleהושלם
Novartis Investigative SiteNantesמגייס
Novartis Investigative SiteParisבוטל
Novartis Investigative SiteStrasbourgבוטל

Germany

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteBerlinבוטל
Novartis Investigative SiteBraunschweigLower Saxonyמגייס
Novartis Investigative SiteCologneNorth Rhine-Westphaliaמגייס
Novartis Investigative SiteFrankfurt am MainHesseבוטל
Novartis Investigative SiteLudwigshafenGermanyבוטל
Novartis Investigative SiteMainzמגייס
Novartis Investigative SiteMunichBavariaבוטל

Hong Kong

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteHong KongHong Kongפעיל, ללא גיוס

Hungary

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteBudapestמגייס
Novartis Investigative SiteDebrecenHajdu Bihar Megyeמגייס
Novartis Investigative SiteSzegedפעיל, ללא גיוס

India

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteAhmedabadGujaratבוטל
Novartis Investigative SiteHyderabadTelanganaמגייס
Novartis Investigative SiteKozhikodeKeralaמגייס
Novartis Investigative SiteLucknowUttar Pradeshמגייס
Novartis Investigative SiteNew DelhiNational Capital Territory of Delhiמגייס
Novartis Investigative SitePuducherryבוטל
Novartis Investigative SiteVelloreTamil Naduבוטל

Israel

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteAshkelonבוטל
Novartis Investigative SiteJerusalemבוטל
Novartis Investigative SiteRamat Ganבוטל

Malaysia

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteKuantanPahangמגייס
Novartis Investigative SiteSelangor Darul Ehsanמגייס
Novartis Investigative SiteTaipingPerakמגייס

Mexico

מתקןעירמדינה או אזורמצב
Novartis Investigative SiteAguascalientesהושלם

53 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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