Status:
COMPLETED
A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
HTLV-1-Associated Myelopathy (HAM)
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 mee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05240612
Start Date
May 2 2022
End Date
December 28 2023
Last Update
January 29 2024
Active Locations (1)
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1
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan, 216-8511