Study of Effectiveness and Safety of LNP023 in Patients With Active Lupus Nephritis Class III-IV, +/- V

RECRUITING

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The overall purpose of this two-part study is to assess the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Conditions:

Lupus Nephritis

Study Start (Actual) 2022-08-10

Primary Completion (Estimated) 2024-10-24

Study Completion (Estimated) 2028-03-13

Enrollment (Estimated) 240

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Phoenix, Arizona, United States

📍 Hinsdale, Illinois, United States

📍 Baltimore, Maryland, United States

📍 Sao Paulo, SP, Brazil

📍 Beijing, China

📍 Wuhan, China

📍 Marseille, France

📍 Nantes Cedex 1, France

📍 Paris, France

📍 Strasbourg Cedex, France

📍 Berlin, Germany

📍 Frankfurt, Germany

📍 Muenchen, Germany

📍 Pokfulam, Hong Kong

📍 Debrecen, Hungary

📍 Vellore, Tamil Nadu, India

📍 New Delhi, India

📍 Puducherry, India

📍 Ashkelon, Israel

📍 Jerusalem, Israel

📍 Ramat Gan, Israel

📍 Kuantan, Pahang, Malaysia

📍 Taiping, Perak, Malaysia

📍 Selangor Darul Ehsan, Malaysia

📍 Tampico, Tamaulipas, Mexico

📍 Merida, Yucatan, Mexico

📍 Veracruz, Mexico

📍 Carnaxide - Linda-A-Velha, Lisboa, Portugal

📍 Lisboa, Portugal

📍 Vila Nova de Gaia, Portugal

📍 San Juan, Puerto Rico

📍 Singapore, Singapore

📍 Sevilla, Andalucia, Spain

📍 Madrid, Spain

📍 Bursa, Gorukle, Turkey

📍 Ankara, Turkey

📍 Istanbul, Turkey

📍 Talas / Kayseri, Turkey

More locations available...

Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-02-24
First Submitted that Met QC Criteria2022-02-24
First Posted2022-03-07

Study Record Updates

Last Update Submitted that Met QC Criteria2024-05-29
Last Update Posted2024-05-30
Last Verified2024-05