Last Update: May 23, 2023
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:
Novartis Reference Number:CLNP023K12201
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.

Lupus Nephritis
Phase 2
Recruiting
240
Aug 10, 2022
Mar 13, 2028
All
18 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 screening 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 10 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 20 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

Study Location

Novartis Investigative Site

Recruiting

Sao Paulo,SP,05403 000,Brazil

Novartis Investigative Site

Recruiting

Beijing,100034,China

Novartis Investigative Site

Recruiting

Wuhan,430022,China

Novartis Investigative Site

Recruiting

Marseille,13385,France

Novartis Investigative Site

Recruiting

Strasbourg Cedex,67091,France

Novartis Investigative Site

Recruiting

Nantes Cedex 1,44093,France

Novartis Investigative Site

Recruiting

Paris,75015,France

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Muenchen,81377,Germany

Novartis Investigative Site

Recruiting

Frankfurt,60590,Germany

Novartis Investigative Site

Recruiting

Pokfulam,Hong Kong

Novartis Investigative Site

Recruiting

Debrecen,4032,Hungary

Novartis Investigative Site

Recruiting

Vellore,Tamil Nadu,632004,India

Novartis Investigative Site

Recruiting

Puducherry,607403,India

Novartis Investigative Site

Recruiting

New Delhi,110029,India

Novartis Investigative Site

Recruiting

Jerusalem,9112001,Israel

Novartis Investigative Site

Recruiting

Ramat Gan,52621,Israel

Novartis Investigative Site

Recruiting

Ashkelon,78278,Israel

Novartis Investigative Site

Recruiting

Selangor Darul Ehsan,68100,Malaysia

Novartis Investigative Site

Recruiting

Kuantan,Pahang,25100,Malaysia

Novartis Investigative Site

Recruiting

Taiping,Perak,34000,Malaysia

Novartis Investigative Site

Recruiting

Veracruz,91900,Mexico

Novartis Investigative Site

Recruiting

Merida,Yucatan,97070,Mexico

Novartis Investigative Site

Recruiting

Tampico,Tamaulipas,8944,Mexico

Novartis Investigative Site

Recruiting

Vila Nova de Gaia,4434 502,Portugal

Novartis Investigative Site

Recruiting

Carnaxide - Linda-A-Velha,Lisboa,2790-134,Portugal

Novartis Investigative Site

Recruiting

Lisboa,1600190,Portugal

Novartis Investigative Site

Recruiting

San Juan,00927,Puerto Rico

Novartis Investigative Site

Recruiting

Singapore,308433,Singapore

Novartis Investigative Site

Recruiting

Sevilla,Andalucia,41009,Spain

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Madrid,28040,Spain

Novartis Investigative Site

Recruiting

Istanbul,34093,Turkey

Novartis Investigative Site

Recruiting

Bursa,Gorukle,16059,Turkey

Novartis Investigative Site

Recruiting

Ankara,06560,Turkey

Novartis Investigative Site

Recruiting

Talas / Kayseri,38039,Turkey

Novartis Investigative Site

Recruiting

Hinsdale,Illinois,60521,United States

Novartis Investigative Site

Recruiting

Phoenix,Arizona,85016,United States

Novartis Investigative Site

Recruiting

Baltimore,Maryland,21287,United States

Worldwide Contacts

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