Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)Phase 1NCT06196905
An Exploratory Study of MT-2990 in Patients With AAV
A Phase 1 study testing MT-2990 in people with Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV), run by Tanabe Pharma Corporation at 8 sites in Japan.
Trial summary
To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)
- What is being tested?
- MT-2990
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 8 sitesJapan
- Study dates
- 24 Jun 2024to 14 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 1) Patients is judged to be indicative of disease activity by the investigator with disease activity satisfying all of the following criteria at screening. If measurements or tests were performed multiple times during the screening period, the results from the latest date should be used to confirm that the criteria are met.
- As elevated CRP due to active AAV, CRP >= 0.2 mg/dL
- BVAS >= 1
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- At least one of the findings in a) to e) below. c) is only applicable to patients with EGPA.
- 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
- 2) Steroid-dependent patients who satisfy the following criteria I and II:
- Worsening of the primary disease due to steroid dose reduction or discontinuation within 6 months before the start of screening period, and then the steroid dose has been maintained at a level exceeding the time point of the worsening. Patients who meet only 2) of the inclusion criteria (3) must be judged by the investigator to be eligible to attempt to discontinue the steroid or reduce the steroid dose to the level at the worsening due to steroid dose reduction by Week 16 in principle.
- No initiation or increased dose of azathioprine or avacopan since the time of the worsening of the primary disease of I.
Who cannot join
- 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.
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- 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.
- Exceptionally, only for rituximab treatment failures are allowed to initiate steroids or increase steroids dose up to that of their most recent induction remission therapy (i.e., doses exceeding 20 mg/day of prednisolone equivalent are allowed) until the day before the first dose.
- Patients who have initiated, increased, or decreased the dose of azathioprine from 4 weeks prior to the start of screening to the time of the first dose.
- Patients who have initiated, increased, or decreased the dose of avacopan from 4 weeks prior to the start of screening to the time of the first dose.
- Patients with concomitant or history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection unless patients have negative test result of hepatitis B virus surface (HBs) antigen, HBs antibody, and hepatitis B virus core (HBc) antibody at screening, or have maintained a negative HCV-RNA test result for at least 12 weeks after completion of hepatitis C treatment.
- Patients with systemic active infections at the day of screening evaluation or the date of the first dose.
- Patients with a history of malignancy within 5 years prior to the start of screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or intraepithelial carcinoma of the cervix who have completed treatment (including therapy other than anticancer agents for the treatment of cancer) without recurrence for at least 1 year.
- History of anaphylaxis or clinically significant allergic symptoms due to administration of antibody products.
- Patients who have received anti-IL-33 antibodies including this investigational drug in the past.
- Patients with serious complications.
- Male and female patients of childbearing potential (Excluding postmenopausal women who have been amenorrheic for at least 1 year and women who have undergone surgical hysterectomy or bilateral oophorectomy) who are unable to obtain consent to use contraception from the date of consent until 12 weeks after completion of study drug administration.
- Female patients who are pregnant, breastfeeding, or possibly pregnant
- Patients who participated in any clinical trial and received the investigational medical product within 12 weeks (or 5 half-lives of investigational medical product, whichever is longer) prior to obtaining consent.
- Patients who are judged by the Investigator to be ineligible for this clinical trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495
Saitama Medical Center
Kawagoe, Saitama, 350-8550
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
NHO Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
About this study
Official title: An Exploratory Study of MT-2990 in Patients With Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)
To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV.
Read the detailed description
Target sample size is 5~10 subjects administered MT-2990
- Being tested
- MT-2990
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-2990Drug
i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| MT-2990 | Experimental | MT-2990 will be administered intravenously every 4 weeks for a total of 6 doses. Receives: Drug: MT-2990 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Birmingham Vasculitis Activity Score (BVAS) at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
Measured: Up to Week 24
Proportion of subjects who achieve BVAS=0 at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in Vasculitis Damage Index (VDI) at each scheduled timepoints.
No primary endpoint is used, because various exploratory analyses are performed.
Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).
Measured: Up to week 24
Patient Global Impression of Change (PGIC) at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Patient Global Impression of Change (PGIC) is a questionnaire to evaluate the overall impression of improvement by patient from 1 (very much improved) to 7 (very much worse). Higher PGIC scores indicated worse outcome.
Measured: Up to week 24
Clinical Global Impression of Change (CGIC) at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Clinician Global Impression of Change (CGIC) a questionnaire to evaluate the overall impression of improvement by clinician from 1 (very much improved) to 7 (very much worse). Higher CGIC scores indicated worse outcome.
Measured: Up to week 24
Change from baseline in FDG-PET/CT findings at week 24
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Baseline and week 24
Change from baseline in chest CT findings at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in head and neck CT/MRI findings at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in respiratory function tests (FVC [mL]) at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in hearing threshold measured by pure-tone audiometry at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Time course of BM {eGFR, urine protein/creatinine ratio (first morning urine), eosinophil count, serum KL-6, CRP, and ANCA-titer (MPO-ANCA, PR3-ANCA)} at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change in dosage of steroid
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in SF-36 at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Change from baseline in EQ-5D-5L at each scheduled timepoints
No primary endpoint is used, because various exploratory analyses are performed.
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start24 Jun 2024
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196905
- Sponsor's protocol ID
- MT-2990-C-101
- Other IDs
- jRCT2031230538
- Status last verified
- Feb 2026
- First submitted
- 25 Dec 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of MT-2990 in Patients With Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)
- ClinicalTrials.gov ID
- NCT06196905
- Acronym / sponsor ID
- MT-2990-C-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV.
Detailed description
Target sample size is 5~10 subjects administered MT-2990
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT-2990 | Experimental | Drug: MT-2990MT-2990 will be administered intravenously every 4 weeks for a total of 6 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
- 1) Patients is judged to be indicative of disease activity by the investigator with disease activity satisfying all of the following criteria at screening. If measurements or tests were performed multiple times during the screening period, the results from the latest date should be used to confirm that the criteria are met.
- As elevated CRP due to active AAV, CRP >= 0.2 mg/dL
Key exclusion criteria (21 listed)
- Exceptionally, only for rituximab treatment failures are allowed to initiate steroids or increase steroids dose up to that of their most recent induction remission therapy (i.e., doses exceeding 20 mg/day of prednisolone equivalent are allowed) until the day before the first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-2990i.v. infusion | Drug | MT-2990 |
Primary outcome
Change from baseline in Birmingham Vasculitis Activity Score (BVAS) at each scheduled timepoints
Time frame: Up to Week 24
No primary endpoint is used, because various exploratory analyses are performed. Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
Proportion of subjects who achieve BVAS=0 at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in Vasculitis Damage Index (VDI) at each scheduled timepoints.
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed. Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).
Patient Global Impression of Change (PGIC) at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed. Patient Global Impression of Change (PGIC) is a questionnaire to evaluate the overall impression of improvement by patient from 1 (very much improved) to 7 (very much worse). Higher PGIC scores indicated worse outcome.
Clinical Global Impression of Change (CGIC) at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed. Clinician Global Impression of Change (CGIC) a questionnaire to evaluate the overall impression of improvement by clinician from 1 (very much improved) to 7 (very much worse). Higher CGIC scores indicated worse outcome.
Change from baseline in FDG-PET/CT findings at week 24
Time frame: Baseline and week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in chest CT findings at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in head and neck CT/MRI findings at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in respiratory function tests (FVC [mL]) at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in hearing threshold measured by pure-tone audiometry at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Time course of BM {eGFR, urine protein/creatinine ratio (first morning urine), eosinophil count, serum KL-6, CRP, and ANCA-titer (MPO-ANCA, PR3-ANCA)} at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change in dosage of steroid
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in SF-36 at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Change from baseline in EQ-5D-5L at each scheduled timepoints
Time frame: Up to week 24
No primary endpoint is used, because various exploratory analyses are performed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-2990 in people with Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV), run by Tanabe Pharma Corporation at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Birmingham Vasculitis Activity Score (BVAS) at each scheduled timepoints (time frame: Up to Week 24). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.