LNP023K12201
Research type
Research Study
Full 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
IRAS ID
1004706
Contact name
Sarah Mofid
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2021-002046-33
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out how safe and well iptacopan works in patients with Class III or IV active lupus nephritis with or without co-existing class V features. All patients will receive the standard treatment for lupus nephritis and iptacopan (or placebo) will be added to this standard treatment. The overall aim of this study is firstly (Part 1) to find out whether the use of iptacopan alongside standard treatment is safe and works well. Once this is established then the aim (Part 2) is to reduce the dose, or completely eliminate, the need for therapy with corticosteroids.
Lupus nephritis is an autoimmune disease which means the body’s natural defense system attacks the kidneys. Its cause is not fully understood. Lupus nephritis is a rare disorder of excessive activation of the alternative complement pathway (AP). AP is an important system in the body which provides protection against infections, however, an over-activated AP is believed to contribute to several kidney diseases, including lupus nephritis. Iptcopan blocks key steps in the AP that may improve lupus nephritis.
The study is split into Part 1 and Part 2. Approximately 80 people with lupus nephritis aged at least 18 years. Based on the results of Part 1, 160 patients will be recruited into Part 2.
Iptacopan or placebo will be given orally at 200 mg twice daily. In addition to iptacopan or placebo, all patients will receive mycophenolate mofetil / mycophenolate sodium (MMF/MPS) and a reducing course of corticosteroids (prednisone or equivalent). These are standard treatments in patients with lupus nephritis.
On study procedures will include medical history, physical exam, height, weight, vital signs, ECG, blood sampling, urinalysis, 24hr urine collection (for lab analysis), patient questionnaires and biopsy, if suitable.REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0097
Date of REC Opinion
17 Jun 2022
REC opinion
Further Information Favourable Opinion