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 range18 Years

SexALL

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.
✕. Patients with autoimmune diseases or vasculitis other than AAV such as systemic lupus erythematosus, IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane nephritis, cryoglobulinemic vasculitis, idiopathic inflammatory muscle disease, systemic sclerosis.
✕. Patients who are judged by the Investigator to have an improvement trend of active finding(s) for AAV during remission maintenance treatment from the 12 weeks prior to the start of screening to the time of the first dose, and to be expected to improve spontaneously without change of treatment.
✕. Patients who received rituximab or immunosuppressive biologics (eg., TNF inhibitors) from 12 weeks prior to the start of screening to the time of the first dose.
✕. Patients who received mepolizumab from 8 weeks prior to the start of screening to the time of the first dose.
✕. Patients who received cyclophosphamide, methotrexate, mycophenolate mofetil, plasma exchange therapy or other immunosuppressive therapy from 4 weeks prior to screening to the time of the first dose.
✕. Patients who received a live vaccine from 4 weeks before the date of the first dose to the time of the first dose.
✕. Patients who have received steroids at prednisolone equivalent doses of more than 20 mg/day, initiated steroids, or increased the dose of steroids from 4 weeks prior to the start of screening to the time of the first dose.

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

Change from baseline in head and neck CT/MRI findings at each scheduled timepoints

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 range18 Years

SexALL

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.
✕. Patients with autoimmune diseases or vasculitis other than AAV such as systemic lupus erythematosus, IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane nephritis, cryoglobulinemic vasculitis, idiopathic inflammatory muscle disease, systemic sclerosis.
✕. Patients who are judged by the Investigator to have an improvement trend of active finding(s) for AAV during remission maintenance treatment from the 12 weeks prior to the start of screening to the time of the first dose, and to be expected to improve spontaneously without change of treatment.
✕. Patients who received rituximab or immunosuppressive biologics (eg., TNF inhibitors) from 12 weeks prior to the start of screening to the time of the first dose.
✕. Patients who received mepolizumab from 8 weeks prior to the start of screening to the time of the first dose.
✕. Patients who received cyclophosphamide, methotrexate, mycophenolate mofetil, plasma exchange therapy or other immunosuppressive therapy from 4 weeks prior to screening to the time of the first dose.
✕. Patients who received a live vaccine from 4 weeks before the date of the first dose to the time of the first dose.
✕. Patients who have received steroids at prednisolone equivalent doses of more than 20 mg/day, initiated steroids, or increased the dose of steroids from 4 weeks prior to the start of screening to the time of the first dose.

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

Change from baseline in head and neck CT/MRI findings at each scheduled timepoints