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

NCT ID: NCT05240612

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2023-12-28

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.

Conditions

HTLV-1-Associated Myelopathy (HAM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT-3921

Intravenous (IV)

Group Type: EXPERIMENTAL

MT-3921

Intervention Type: BIOLOGICAL

Solution for infusion; Intravenous (IV)

Placebo

Intravenous (IV)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Solution for infusion; Intravenous (IV)

Interventions

MT-3921

Solution for infusion; Intravenous (IV)

Intervention Type: BIOLOGICAL

Placebo

Solution for infusion; Intravenous (IV)

Intervention Type: BIOLOGICAL

Other Intervention Names

Unasnemab

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, Japan

Countries

Japan

Other Identifiers

jRCT2031210616

Identifier Type: REGISTRY

Identifier Source: secondary_id

MT-3921-C-101

Identifier Type: -

Identifier Source: org_study_id