A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA-associated vasculitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510525-15-00

Acronym

CLNP023R12201

Enrollment

Registered

2024-09-17

Start date

2024-11-18

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

active antineutrophilic cytoplasmic antibody (ANCA) associated vasculitis

Brief summary

Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.

Detailed description

Time to reach BVAS = 0, Time to major relapse through Week 48, Estimated glomerular filtration rate (eGFR) using the CKD-EI formula, urinary protein excretion and hematuria over 48 weeks.

Interventions

DRUGIPTACOPAN

DRUGPlacebo 0 mg hard gelatin capsule size 0

DRUG(placebo to LNP023)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Time to reach BVAS = 0, Time to major relapse through Week 48, Estimated glomerular filtration rate (eGFR) using the CKD-EI formula, urinary protein excretion and hematuria over 48 weeks.	—

Primary

Measure	Time frame
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Netherlands, Spain

Outcome results

None listed

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