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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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.

المرحلة 2مطلوب 240 مشاركاً103 مواقع20 دولة

الفئات

الكلى والمسالك البولية58%المناعة والروماتيزم27%الأمراض الجلدية8%التوليد وأمراض النساء8%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Lupus Nephritis

الأهلية

الجنسالجميع
الأعمار18 Years – 100 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2
التخصيصمعشّاة
نموذج التدخّلSEQUENTIAL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 240 مشاركاً

الجهة الراعية والمتعاونون

  • Novartis Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء Iptacopan (part 1)

    Taken for 52 Weeks

  • دواء Iptacopan (part 2)

    Taken for 52 Weeks

  • دواء Iptacopan + placebo

    Taken for 52 Weeks

  • دواء Placebo + standard of care

    Taken for 52 Weeks

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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.

    الإطار الزمني Baseline and week 24

  2. مقياس النتيجة الثانوي

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

    Measure disease activity

    الإطار الزمني Weeks 24 and 52

  3. مقياس النتيجة الثانوي

    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

    الإطار الزمني Baseline, week 24, week 52

  4. مقياس النتيجة الثانوي

    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

    الإطار الزمني Baseline, week 24 week 52

  5. مقياس النتيجة الثانوي

    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)

    الإطار الزمني Baseline week 24

  6. مقياس النتيجة الثانوي

    Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    الإطار الزمني Weeks 24 and 52

  7. مقياس النتيجة الثانوي

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

    Measure disease activity in SLE

    الإطار الزمني Weeks 24 and 52

  8. مقياس النتيجة الثانوي

    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

    الإطار الزمني Week 24 and Week 52

التواريخ

تاريخ البدء10 أغسطس 2022 (فعلي)
الإتمام الأولي19 مارس 2026 (فعلي)
الإتمام28 سبتمبر 2028 (تقديري)
أول نشر7 مارس 2022 (فعلي)
آخر تحديث30 يوليو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

39 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteRosarioSanta Fe Provinceمسحوب
Novartis Investigative SiteSan Luisمسحوب
Novartis Investigative SiteSanta Feنشط، دون تجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBarretosSão Pauloنشط، دون تجنيد
Novartis Investigative SiteBelo HorizonteMinas Geraisمكتمل
Novartis Investigative SiteJuiz de ForaMinas Geraisنشط، دون تجنيد
Novartis Investigative SiteSalvadorEstado de Bahiaنشط، دون تجنيد
Novartis Investigative SiteSalvadorنشط، دون تجنيد
Novartis Investigative SiteSão PauloSão Pauloنشط، دون تجنيد
Novartis Investigative SiteSão PauloSão Pauloنشط، دون تجنيد
Novartis Investigative SiteSão PauloSão Pauloمكتمل

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBeijingنشط، دون تجنيد
Novartis Investigative SiteNanningGuangxiمكتمل
Novartis Investigative SiteShenyangLiaoningقيد التجنيد
Novartis Investigative SiteShenzhenقيد التجنيد
Novartis Investigative SiteWuhanHubeiقيد التجنيد
Novartis Investigative SiteYinchuanNingxiaنشط، دون تجنيد

Colombia

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBarranquillaAtlánticoنشط، دون تجنيد
Novartis Investigative SiteBogotaCundinamarcaنشط، دون تجنيد
Novartis Investigative SiteBucaramangaSantander Departmentنشط، دون تجنيد
Novartis Investigative SiteMonteríaمكتمل

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteMarseilleمكتمل
Novartis Investigative SiteNantesقيد التجنيد
Novartis Investigative SiteParisمسحوب
Novartis Investigative SiteStrasbourgمسحوب

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBerlinمسحوب
Novartis Investigative SiteBraunschweigLower Saxonyقيد التجنيد
Novartis Investigative SiteCologneNorth Rhine-Westphaliaقيد التجنيد
Novartis Investigative SiteFrankfurt am MainHesseمسحوب
Novartis Investigative SiteLudwigshafenGermanyمسحوب
Novartis Investigative SiteMainzقيد التجنيد
Novartis Investigative SiteMunichBavariaمسحوب

Hong Kong

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteHong KongHong Kongنشط، دون تجنيد

Hungary

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBudapestقيد التجنيد
Novartis Investigative SiteDebrecenHajdu Bihar Megyeقيد التجنيد
Novartis Investigative SiteSzegedنشط، دون تجنيد

India

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteAhmedabadGujaratمسحوب
Novartis Investigative SiteHyderabadTelanganaقيد التجنيد
Novartis Investigative SiteKozhikodeKeralaقيد التجنيد
Novartis Investigative SiteLucknowUttar Pradeshقيد التجنيد
Novartis Investigative SiteNew DelhiNational Capital Territory of Delhiقيد التجنيد
Novartis Investigative SitePuducherryمسحوب
Novartis Investigative SiteVelloreTamil Naduمسحوب

Israel

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteAshkelonمسحوب
Novartis Investigative SiteJerusalemمسحوب
Novartis Investigative SiteRamat Ganمسحوب

Malaysia

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteKuantanPahangقيد التجنيد
Novartis Investigative SiteSelangor Darul Ehsanقيد التجنيد
Novartis Investigative SiteTaipingPerakقيد التجنيد

Mexico

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteAguascalientesمكتمل

يُدرَج 53 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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