CLNP023R12201
Research type
Research Study
Full title
A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA associated vasculitis
IRAS ID
1010484
Contact name
Narae Bae
Contact email
Sponsor organisation
Novartis Pharmaceuticals Corporation
Research summary
This study is designed to find out if iptacopan at a dose of 200 mg twice daily is safe and effective when used together with rituximab and quick reduction of glucocorticoids (GC) dose, can help patients with ANCA-associated vasculitis to become better (induce remission) and keep the disease controlled (maintain remission) without rituximab redosing.
ANCA-associated vasculitis (AAV) is a group of disease that makes your body attack healthy cells by mistake and is characterized by damage to small blood vessels. The two most common types of AAV are granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). AAV is affected by uncontrolled activation of an important system in the body called the complement alternative pathway (AP). The “AP” usually provides protection against infections.
Iptacopan is a new oral medication being developed in AAV, which blocks the activity of a protein called factor B which is part of the “AP”. By preventing activation of AP, it is expected to reduce AAV symptoms including tissue damage.
This is a randomized study that will last for a duration of up to 54 weeks. Participants will receive iptacopan or placebo on top of rituximab and quick reduction of glucocorticoid dose for the treatment of newly diagnosed or relapsed (return of the disease) active GPA or MPA. The study consists of 4 periods: screening period (up to 2 weeks), induction period (24 weeks), maintenance period (24 weeks), and safety follow-up period (4 weeks).
Approximately 78 participants aged 18 years or older with newly diagnosed or relapsed active GPA or MPA who require treatment with rituximab and glucocorticoid will be enrolled in the study.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0869
Date of REC Opinion
9 Jan 2025
REC opinion
Further Information Favourable Opinion