Last Update: Jul 30, 2026 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 ClinicalTrials.gov Identifier: [NCT05268289](https://clinicaltrials.gov/ct2/show/NCT05268289) Novartis Reference Number:CLNP023K12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study 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. 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. Condition Lupus Nephritis Phase Phase2 Overall Status Recruiting Number of Participants240 Start Date Aug 10, 2022 Completion Date Sep 28, 2028 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## 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 ## Eligibility Criteria 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 China #### Novartis Investigative Site Recruiting Shenzhen,518036,China #### Novartis Investigative Site Recruiting Wuhan,Hubei,430022,China #### Novartis Investigative Site Recruiting Shenyang,Liaoning,110004,China France #### Novartis Investigative Site Recruiting Nantes,44093,France Germany #### Novartis Investigative Site Recruiting Mainz,55131,Germany #### Novartis Investigative Site Recruiting Cologne,North Rhine-Westphalia,51109,Germany #### Novartis Investigative Site Recruiting Braunschweig,Lower Saxony,38126,Germany Hungary #### Novartis Investigative Site Recruiting Budapest,H-1083,Hungary #### Novartis Investigative Site Recruiting Debrecen,Hajdu Bihar Megye,4032,Hungary India #### Novartis Investigative Site Recruiting Lucknow,Uttar Pradesh,226014,India #### Novartis Investigative Site Recruiting Hyderabad,Telangana,500082,India #### Novartis Investigative Site Recruiting New Delhi,National Capital Territory of Delhi,110029,India #### Novartis Investigative Site Recruiting Kozhikode,Kerala,673008,India Malaysia #### Novartis Investigative Site Recruiting Kuantan,Pahang,25100,Malaysia #### Novartis Investigative Site Recruiting Taiping,Perak,34000,Malaysia #### Novartis Investigative Site Recruiting Selangor Darul Ehsan,68100,Malaysia Philippines #### Novartis Investigative Site Recruiting Makati City,National Capital Region,1218,Philippines #### Novartis Investigative Site Recruiting Quezon,1102,Philippines Portugal #### Novartis Investigative Site Recruiting Vila Nova de Gaia,4434 502,Portugal Puerto Rico #### FDI Clinical Research Recruiting San Juan,00927,Puerto Rico ###### Jose Cangiano ###### Digmarie Rivera Franceschini Phone: [+1 787 722 1248]() Email: Singapore #### Novartis Investigative Site Recruiting Singapore,Singapore,S308433,Singapore Spain #### Novartis Investigative Site Recruiting Ciudad Real,13005,Spain #### Novartis Investigative Site Recruiting Madrid,28040,Spain #### Novartis Investigative Site Recruiting Madrid,28034,Spain Turkey (Türkiye) #### Novartis Investigative Site Recruiting Bursa,Nilufer,16059,Turkey (Türkiye) United States #### Wichita Community Clcl Onco Program Recruiting Wichita,Kansas,67214,United States ###### Wissam Saliba ###### Barb Johnson Phone: [+1 316 494 4912]() Email: #### Ronald Reagan UCLA Medical Center Recruiting Los Angeles,California,90095,United States ###### Lama Abdelnour ###### Rana Nikbakht Malvajerdi Email: #### University of Colorado Denver Recruiting Aurora,Colorado,80045,United States ###### Amber Podoll ###### Elizabeth Wagner Email: #### Royal Research Corp Recruiting Hollywood,Florida,33021,United States ###### Elio Torres ###### Yaili Perez Phone: [+1 954 940 0208]() Email: #### Mayo Clinic Jacksonville Recruiting Jacksonville,Florida,32224,United States ###### Nabeel Aslam ###### Tia Wilkes Phone: [+1 904 953 7648]() Email: #### Florida Kidney Physicians Recruiting Riverview,Florida,33578,United States ###### Amit Johnsingh ###### Marc Richards ###### Myra Rodriguez Email: ###### Yvette Martinez Email: #### Prolato Clinical Research Center Recruiting Houston,Texas,77054,United States ###### Biruh Workeneh ###### Dilshad Begum Phone: [+1 832 338 9118]() Email: #### Ochsner Health System Recruiting New Orleans,Louisiana,70121,United States ###### Gavin Skipper Phone: [+1 504 842 3930]() Email: ###### Ivo Lukitsch #### Brigham and Womens Hosp Harvard Med School Recruiting Boston,Massachusetts,02115,United States ###### Finnian McCausland ###### Valentina Castro Email: #### Cleveland Clinic Foundation Recruiting Cleveland,Ohio,44195,United States ###### Sarah Cleveland Email: ###### Laura Ferreira-Provenzano #### Stony Brook Internists PC Recruiting East Setauket,New York,11733,United States ###### Asad Syed Email: ###### Sobia Khan #### Temple University Recruiting Philadelphia,Pennsylvania,19140,United States ###### Iris Lee ###### Julia Aruta Phone: [+1 215 707 8984]() Email: #### Virginia Commonwealth University Recruiting Richmond,Virginia,23298,United States ###### Keila Najera Phone: [+1 804 828 0180]() Email: ###### Jason Kidd ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: