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HTLV-1-Associated Myelopathy (HAM)

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)

Sponsored by Mitsubishi Tanabe Pharma Corporation

About this trial

Last updated 2 years ago

Study ID

MT-3921-C-101

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
20+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM). Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- 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

Locations

Location

Status