CompletedPhase 1

An Exploratory Study of MT-2990 in Patients With AAV

Japan5 participantsStarted 2024-06-24

Plain-language summary

To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged 18 years or older on the day of informed consent
. Clinical diagnosis of microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), or eosinophilic granulomatosis with polyangiitis (EGPA) according to 2022 ACR/EULAR Classification Criteria by the date of informed consent
. Patients who meet at least one of the following criteria 1) or 2)
. FDG-PET/CT image finding(s) (Grade \>= 2 \[defined as FDG uptake = liver\], and judged that the findings indicate inflammation by radiologist)
. FVC(mL) below the lower limit of normal calculated using the "new reference range for Japanese using LMS method" and KL-6 \>= 500 U/mL
. History or presence of asthma and eosinophils counts \>= 1000/µL
. eGFR \< 60 mL/min/1.73 m 2 and first-morning urine protein/creatinine ratio \> 0.2 g/g Cr
. Presence of hearing loss due to active AAV and air conduction hearing threshold (average of measurements at 0.25,0.5,1, 2, and 4 kHz) \>= 30 dB in at least one ear

Exclusion criteria

. Patients who have manifestations leading to life-threatening or vital organ dysfunction due to AAV, in the opinion of the Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Birmingham Vasculitis Activity Score (BVAS) at each scheduled timepoints

Timeframe: Up to Week 24

Proportion of subjects who achieve BVAS=0 at each scheduled timepoints

Timeframe: Up to week 24

Change from baseline in Vasculitis Damage Index (VDI) at each scheduled timepoints.

Timeframe: Up to week 24

Patient Global Impression of Change (PGIC) at each scheduled timepoints

Timeframe: Up to week 24

Clinical Global Impression of Change (CGIC) at each scheduled timepoints

Timeframe: Up to week 24

Change from baseline in FDG-PET/CT findings at week 24

Timeframe: Baseline and week 24

Change from baseline in chest CT findings at each scheduled timepoints

Timeframe: Up to week 24

Trial details

NCT IDNCT06196905

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-14

View on ClinicalTrials.gov More Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged 18 years or older on the day of informed consent
. Clinical diagnosis of microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), or eosinophilic granulomatosis with polyangiitis (EGPA) according to 2022 ACR/EULAR Classification Criteria by the date of informed consent
. Patients who meet at least one of the following criteria 1) or 2)
. FDG-PET/CT image finding(s) (Grade \>= 2 \[defined as FDG uptake = liver\], and judged that the findings indicate inflammation by radiologist)
. FVC(mL) below the lower limit of normal calculated using the "new reference range for Japanese using LMS method" and KL-6 \>= 500 U/mL
. History or presence of asthma and eosinophils counts \>= 1000/µL
. eGFR \< 60 mL/min/1.73 m 2 and first-morning urine protein/creatinine ratio \> 0.2 g/g Cr
. Presence of hearing loss due to active AAV and air conduction hearing threshold (average of measurements at 0.25,0.5,1, 2, and 4 kHz) \>= 30 dB in at least one ear

Exclusion criteria

. Patients who have manifestations leading to life-threatening or vital organ dysfunction due to AAV, in the opinion of the Investigator.

What they're measuring

Change from baseline in Birmingham Vasculitis Activity Score (BVAS) at each scheduled timepoints

Timeframe: Up to Week 24

Proportion of subjects who achieve BVAS=0 at each scheduled timepoints

Timeframe: Up to week 24

Change from baseline in Vasculitis Damage Index (VDI) at each scheduled timepoints.

Timeframe: Up to week 24

Patient Global Impression of Change (PGIC) at each scheduled timepoints

Timeframe: Up to week 24

Clinical Global Impression of Change (CGIC) at each scheduled timepoints

Timeframe: Up to week 24

Change from baseline in FDG-PET/CT findings at week 24

Timeframe: Baseline and week 24

Change from baseline in chest CT findings at each scheduled timepoints

Timeframe: Up to week 24