A three-period multicenter study, with a randomized-withdrawal, double-blinded, placebo-controlled design to evaluate the clinical efficacy, safety and tolerability of MAS825 in patients with monogenic IL-18 driven autoinflammatory diseases, including NLRC4-GOF, XIAP deficiency, or CDC42 mutations.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504419-34-00

Acronym

CMAS825D12201

Enrollment

Registered

2024-06-10

Start date

2021-04-29

Completion date

Unknown

Last updated

2025-11-07

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

Conditions

Autoinflammatory diseases including NLRC4-Gain of Function (GOF) also known as AIFEC (autoinflammation with infantile enterocolitis), or Cell division control protein 42 homolog (CDC42) mutation., X-linked Inhibitor of Apoptosis Protein (XIAP) deficiency

Brief summary

Occurrence of disease flare in patients with MAS825 treated patients compared with placebo during Period 2 assessed by Physician's Global Assessment and inflammatory markers

Detailed description

- Confirmation of serological markers of MAS825, - PGA and inflammatory markers at Day 29, end of Period 1 and Period 2, - Serological remission via inflammatory markers, - Glucocorticoid therapy ≤0.2mg/kg/day by end of period 1, - Time to first flare during period 2, - Physician Severity Assessment of Disease Signs and Symptoms scale, - Patient' / Parent's global assessment of disease activity (PPGA) scale

Interventions

DRUG-

DRUGPlacebo to MAS825 100 mg/1 mL Concentrate for solution for infusion / Solution for injection

DRUGMAS825

DRUGCICLOSPORIN

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Occurrence of disease flare in patients with MAS825 treated patients compared with placebo during Period 2 assessed by Physician's Global Assessment and inflammatory markers	—

Secondary

Measure	Time frame
- Confirmation of serological markers of MAS825, - PGA and inflammatory markers at Day 29, end of Period 1 and Period 2, - Serological remission via inflammatory markers, - Glucocorticoid therapy ≤0.2mg/kg/day by end of period 1, - Time to first flare during period 2, - Physician Severity Assessment of Disease Signs and Symptoms scale, - Patient' / Parent's global assessment of disease activity (PPGA) scale	—

Measure

Time frame

—

Countries

Czechia, France, Italy, Spain

Outcome results

None listed

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