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A Clinical Pharmacological Study of MT-3921 in Subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)

A Clinical Pharmacological Study of MT-3921 in Subjects with HAM

Kazuoki Kondou

Mitsubishi Tanabe Pharma Corporation

1-1-1, Marunouchi Chiyoda-ku, Tokyo

cti-inq-ml@ml.mt-pharma.co.jp

Clinical Trials Information Desk

Mitsubishi Tanabe Pharma Corporation

1-1-1, Marunouchi Chiyoda-ku, Tokyo

+81-3-5960-9608

cti-inq-ml@ml.mt-pharma.co.jp

Complete

May. 02, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Additional screening criteria check may apply for qualification:
- Subjects aged 20 years or older on the day of consent
- Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent
- Subjects with an Osame's motor disability score (OMDS) of >=4 and =<6 at Screening and on the first day of the Treatment period (predose)
- Subjects with no change in OMDS for at least 3 months before the day of consent
- Subjects with a CSF concentration neopterin of >=6 pmol/mL at Screening
-Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to =<10 mg/day of prednisolone for at least 3 months before the day of consent

Additional screening criteria check may apply for qualification:
- Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
- Subjects exhibiting or with a history of malignant tumor.
- Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
- Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
- Subjects with psychiatric disorders, epileptic seizures, or dementia.
- Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
- Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
- Subjects with the novel Coronavirus disease 2019 (COVID-19)
- Subjects with severe illness
- Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
- Female subjects who are pregnant, lactating, or may be pregnant
- Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
- Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent

Both

Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)

MT-3921 or placebo will be administered intravenously.

Percentage of subjects with adverse events
Percentage of subjects with adverse reactions
Serum concentrations of MT-3921
CSF concentrations of MT-3921

+81-44-977-8111

Feb. 17, 2022

No

none