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

RecruitingTaking participants now, according to the registry record.

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In brief

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 sought103 sites20 countries

Registered in 1 registry

ClinicalTrials.govNCT05268289Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

Present: Registered before enrolment beganFirst posted 2022-03-07; recorded start 2022-08-10
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
Present: 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.

Summary

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.

Conditions

Lupus Nephritis

Eligibility

Eligibility
Sex	All
Ages	18 Years – 100 Years
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 2
Allocation	Randomised
Intervention model	SEQUENTIAL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	240 participants sought

Sponsor and collaborators

Novartis Pharmaceuticals Sponsor

Arms and 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

Drug Iptacopan (part 1)
Taken for 52 Weeks
Drug Iptacopan (part 2)
Taken for 52 Weeks
Drug Iptacopan + placebo
Taken for 52 Weeks
Drug Placebo + standard of care
Taken for 52 Weeks

Outcome measures

Primary outcome
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.
Time frame Baseline and week 24
Secondary outcome
Change from baseline in BILAG-2004 score at weeks 24 and 52
Measure disease activity
Time frame Weeks 24 and 52
Secondary outcome
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
Time frame Baseline, week 24, week 52
Secondary outcome
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
Time frame Baseline, week 24 week 52
Secondary outcome
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)
Time frame Baseline week 24
Secondary outcome
Change from baseline FACIT-Fatigue Score
Measure fatigue in patients
Time frame Weeks 24 and 52
Secondary outcome
Change from baseline in SLEDAI-2K score at weeks 24 and 52
Measure disease activity in SLE
Time frame Weeks 24 and 52
Secondary outcome
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
Time frame Week 24 and Week 52

Dates

Dates
Start date	August 10, 2022 (actual)
Primary completion	March 19, 2026 (actual)
Completion	September 28, 2028 (estimated)
First posted	March 7, 2022 (actual)
Last updated	July 30, 2026
Results posted	Not stated in the registry record
Status last verified	July 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

39 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
Novartis Investigative Site	Rosario	Santa Fe Province	Withdrawn
Novartis Investigative Site	San Luis		Withdrawn
Novartis Investigative Site	Santa Fe		Active, not recruiting

Brazil

Brazil
Facility	City	State or region	Status
Novartis Investigative Site	Barretos	São Paulo	Active, not recruiting
Novartis Investigative Site	Belo Horizonte	Minas Gerais	Completed
Novartis Investigative Site	Juiz de Fora	Minas Gerais	Active, not recruiting
Novartis Investigative Site	Salvador	Estado de Bahia	Active, not recruiting
Novartis Investigative Site	Salvador		Active, not recruiting
Novartis Investigative Site	São Paulo	São Paulo	Active, not recruiting
Novartis Investigative Site	São Paulo	São Paulo	Active, not recruiting
Novartis Investigative Site	São Paulo	São Paulo	Completed

China

China
Facility	City	State or region	Status
Novartis Investigative Site	Beijing		Active, not recruiting
Novartis Investigative Site	Nanning	Guangxi	Completed
Novartis Investigative Site	Shenyang	Liaoning	Recruiting
Novartis Investigative Site	Shenzhen		Recruiting
Novartis Investigative Site	Wuhan	Hubei	Recruiting
Novartis Investigative Site	Yinchuan	Ningxia	Active, not recruiting

Colombia

Colombia
Facility	City	State or region	Status
Novartis Investigative Site	Barranquilla	Atlántico	Active, not recruiting
Novartis Investigative Site	Bogota	Cundinamarca	Active, not recruiting
Novartis Investigative Site	Bucaramanga	Santander Department	Active, not recruiting
Novartis Investigative Site	Montería		Completed

France

France
Facility	City	Status
Novartis Investigative Site	Marseille	Completed
Novartis Investigative Site	Nantes	Recruiting
Novartis Investigative Site	Paris	Withdrawn
Novartis Investigative Site	Strasbourg	Withdrawn

Germany

Germany
Facility	City	State or region	Status
Novartis Investigative Site	Berlin		Withdrawn
Novartis Investigative Site	Braunschweig	Lower Saxony	Recruiting
Novartis Investigative Site	Cologne	North Rhine-Westphalia	Recruiting
Novartis Investigative Site	Frankfurt am Main	Hesse	Withdrawn
Novartis Investigative Site	Ludwigshafen	Germany	Withdrawn
Novartis Investigative Site	Mainz		Recruiting
Novartis Investigative Site	Munich	Bavaria	Withdrawn

Hong Kong

Hong Kong
Facility	City	State or region	Status
Novartis Investigative Site	Hong Kong	Hong Kong	Active, not recruiting

Hungary

Hungary
Facility	City	State or region	Status
Novartis Investigative Site	Budapest		Recruiting
Novartis Investigative Site	Debrecen	Hajdu Bihar Megye	Recruiting
Novartis Investigative Site	Szeged		Active, not recruiting

India

India
Facility	City	State or region	Status
Novartis Investigative Site	Ahmedabad	Gujarat	Withdrawn
Novartis Investigative Site	Hyderabad	Telangana	Recruiting
Novartis Investigative Site	Kozhikode	Kerala	Recruiting
Novartis Investigative Site	Lucknow	Uttar Pradesh	Recruiting
Novartis Investigative Site	New Delhi	National Capital Territory of Delhi	Recruiting
Novartis Investigative Site	Puducherry		Withdrawn
Novartis Investigative Site	Vellore	Tamil Nadu	Withdrawn

Israel

Israel
Facility	City	Status
Novartis Investigative Site	Ashkelon	Withdrawn
Novartis Investigative Site	Jerusalem	Withdrawn
Novartis Investigative Site	Ramat Gan	Withdrawn

Malaysia

Malaysia
Facility	City	State or region	Status
Novartis Investigative Site	Kuantan	Pahang	Recruiting
Novartis Investigative Site	Selangor Darul Ehsan		Recruiting
Novartis Investigative Site	Taiping	Perak	Recruiting

Mexico

Mexico
Facility	City	State or region	Status
Novartis Investigative Site	Aguascalientes		Completed

53 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Brazil

China

Colombia

France

Germany

Hong Kong

Hungary

India

Israel

Malaysia

Mexico

Study documents

Changes over time