HTLV-1-Associated Myelopathy (HAM)
Conditions
Brief summary
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.
Interventions
BIOLOGICALMT-3921
Solution for infusion; Intravenous (IV)
BIOLOGICALPlacebo
Solution for infusion; Intravenous (IV)
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with adverse events | 36 weeks |
| Percentage of subjects with adverse reactions | 36 weeks |
| Serum concentrations of MT-3921 | PK samples will be collected at predose, 1.5 hours, 2, 4, 8, 12, 20 (predose and 1.5 hours), 24, 36 weeks post-dose. |
| CSF concentrations of MT-3921 | PK samples will be collected at 2, 4, 12, 24 weeks post-dose. |
Countries
Japan
Outcome results
None listed