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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 adult patients with active lupus nephritis Class III-IV, +/- V

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509332-26-00
Acronym
CLNP023K12201
Enrollment
48
Registered
2024-07-15
Start date
2023-02-16
Completion date
Unknown
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis Class III-IV, +/- V

Brief summary

Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

Detailed description

Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares at weeks 24 and 52, Time-to-Complete Renal Response (CRR) based on first morning void (FMV) urine samples, Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24, Frequency of courses of corticosteroids for renal and non-renal indications at a dose exceeding an average of 20mg/day (of prednisolone or equivalent) for more than 10 days between weeks 24 and 52, Change from baseline FACIT-Fatigue Score at weeks 24 and 52, Change from baseline in SLEDAI-2K score at weeks 24 and 52, Change from baseline in BILAG-2004 score at weeks 24 and 52, Safety endpoints up to week 52 for Part 1 and 2, Log-transformed ratio to baseline of 24h UPCR at week 24

Interventions

DRUGMYCOPHENOLIC ACID
DRUGPREDNISONE
DRUGPlacebo 0 mg hard gelatin capsule size 0 and size 2
DRUGMETHYLPREDNISOLONE
DRUGIPTACOPAN
DRUGLNP023

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

Secondary

MeasureTime frame
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares at weeks 24 and 52, Time-to-Complete Renal Response (CRR) based on first morning void (FMV) urine samples, Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24, Frequency of courses of corticosteroids for renal and non-renal indications at a dose exceeding an average of 20mg/day (of prednisolone or equivalent) for more than 10 days between weeks 24 and 52, Change from baseline FACIT-Fatigue Score at weeks 24 and 52, Change from baseline in SLEDAI-2K score at weeks 24 and 52, Change from baseline in BILAG-2004 score at weeks 24 and 52, Safety endpoints up to week 52 for Part 1 and 2, Log-transformed ratio to baseline of 24h UPCR at week 24

Countries

France, Germany, Hungary, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026