Lupus NephritisPhase 2NCT05268289
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
A Phase 2 study testing Iptacopan (part 1) and Iptacopan (part 2) in people with Lupus Nephritis, run by Novartis Pharmaceuticals at 74 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Iptacopan (part 1) and Iptacopan (part 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 74 sitesin 19 countries
- Study dates
- 10 Aug 2022to 1 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
74 sites in 19 countries.
74 sites in 19 countries
United States16 sites
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Dallas Nephrology Associates
Dallas, Texas, 75204
Stony Brook Internists PC
East Setauket, New York, 11733
Nep Assoc of Northern Illinois
Hinsdale, Illinois, 60521
Royal Research Corp
Hollywood, Florida, 33021
Prolato Clinical Research Center
Houston, Texas, 77054
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Ochsner Health System
New Orleans, Louisiana, 70121
Nephrology Associates Of Central FL
Orlando, Florida, 32806
Temple University
Philadelphia, Pennsylvania, 19140
Florida Kidney Physicians
Riverview, Florida, 33578
Loma Linda University
San Bernardino, California, 92408
Olive View UCLA Medical Center
Sylmar, California, 91342
Wichita Community Clcl Onco Program
Wichita, Kansas, 67214
Brazil8 sites
Novartis Investigative Site
Barretos, São Paulo, 14784-400
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
Novartis Investigative Site
Juiz de Fora, Minas Gerais, 36010-570
Novartis Investigative Site
Salvador, Estado de Bahia, 40150-150
Novartis Investigative Site
Salvador, 40323-010
Novartis Investigative Site
São Paulo, São Paulo, 01308-050
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
China6 sites
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Nanning, Guangxi, 530022
Novartis Investigative Site
Shenyang, Liaoning, 110004
Novartis Investigative Site
Shenzhen, 518036
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Yinchuan, Ningxia, 750004
Spain5 sites
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
Ciudad Real, 13005
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Seville, 41009
Turkey (Türkiye)5 sites
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Bursa, Nilufer, 16059
Novartis Investigative Site
Istanbul, Fatih, 34093
Novartis Investigative Site
Kayseri, Melikgazi, 38039
Novartis Investigative Site
Mersin, Yenisehir, 33110
Colombia4 sites
Novartis Investigative Site
Barranquilla, Atlántico, 080020
Novartis Investigative Site
Bogota, Cundinamarca, 111411
Novartis Investigative Site
Bucaramanga, Santander Department, 680003
Novartis Investigative Site
Montería, 230004
India4 sites
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Kozhikode, Kerala, 673008
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Mexico4 sites
Novartis Investigative Site
Aguascalientes, 20230
Novartis Investigative Site
Mérida, Yucatán, 97070
Novartis Investigative Site
Tampico, Tamaulipas, 89440
Novartis Investigative Site
Veracruz, 91900
Portugal4 sites
Novartis Investigative Site
Carnaxide, 2799-523
Novartis Investigative Site
Coimbra, 3004-561
Novartis Investigative Site
Lisbon, 1649-035
Novartis Investigative Site
Vila Nova de Gaia, 4434-502
Germany3 sites
Novartis Investigative Site
Braunschweig, Lower Saxony, 38126
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 51109
Novartis Investigative Site
Mainz, 55131
Hungary3 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Novartis Investigative Site
Szeged, 6725
Malaysia3 sites
Novartis Investigative Site
Kuantan, Pahang, 25100
Novartis Investigative Site
Selangor Darul Ehsan, 68100
Novartis Investigative Site
Taiping, Perak, 34000
France2 sites
Novartis Investigative Site
Marseille, 13005
Novartis Investigative Site
Nantes, 44093
Philippines2 sites
Novartis Investigative Site
Makati City, National Capital Region, 1218
Novartis Investigative Site
Quezon, 1102
About this study
Official title: 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
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.
Read the detailed description
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
- Being tested
- Iptacopan (part 1), Iptacopan (part 2), Placebo + standard of care, Iptacopan + placebo
- Keywords
- LNP023, Iptacopan, Lupus Nephritis, proteinuria, Urine Protein-to-Creatinine Ratio, complete renal response, estimated glomerular filtration rate, renal flares, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Nephritis, Proteinuria, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iptacopan (part 1)Drug
Also called LNP023
Taken for 52 Weeks
Iptacopan (part 2)Drug
Also called LNP023
Taken for 52 Weeks
Placebo + standard of careDrug
Taken for 52 Weeks
Iptacopan + placeboDrug
Also called LNP023 and placebo
Taken for 52 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Iptacopan + standard of care (part 1) | Active comparator | Iptacopan + standard of care Receives: Drug: Iptacopan (part 1) |
| Placebo matching iptacopan + standard of care (part 1) | Placebo comparator | Placebo matching iptacopan standard of care Receives: Drug: Placebo + standard of care |
| Iptacopan + standard of care (part 2) | Active comparator | Iptacopan + standard of care Receives: Drug: Iptacopan (part 2) |
| Iptacopan + placebo (part 2) | Active comparator | Iptacopan + placebo standard of care Receives: Drug: Iptacopan + placebo |
| Placebo matching iptacopan + standard of care (part 2) | Active comparator | Placebo matching iptacopan + standard of care Receives: Drug: Placebo + standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 24
Secondary outcomes (7)
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
Measured: Baseline, week 24, week 52
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
Measured: Baseline, week 24 week 52
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)
Measured: Baseline week 24
Change from baseline FACIT-Fatigue Score
Measure fatigue in patients
Measured: Weeks 24 and 52
Change from baseline in SLEDAI-2K score at weeks 24 and 52
Measure disease activity in SLE
Measured: Weeks 24 and 52
Change from baseline in BILAG-2004 score at weeks 24 and 52
Measure disease activity
Measured: Weeks 24 and 52
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
Measured: Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start10 Aug 2022
- Primary completion19 Mar 2026
- Study completion1 Oct 2026
Why it stopped: The decision to conclude the study after Part 1 LPLV is based on strategic considerations by the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268289
- Sponsor's protocol ID
- CLNP023K12201
- Other IDs
- 2021-002046-33
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
PubMed 37528520