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

Primary Purpose

HTLV-1-Associated Myelopathy (HAM)

Status

Active

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

MT-3921

Placebo

About this trial

This is an interventional treatment trial for HTLV-1-Associated Myelopathy (HAM)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Marianna University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-3921

Placebo

Arm Description

Intravenous (IV)

Outcomes

Primary Outcome Measures

Percentage of subjects with adverse events

Percentage of subjects with adverse reactions

Serum concentrations of MT-3921

CSF concentrations of MT-3921

Secondary Outcome Measures

Full Information

NCT ID

NCT05240612

First Posted

February 13, 2022

Last Updated

September 20, 2023

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05240612

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 2, 2022 (Actual)

Primary Completion Date

September 14, 2023 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HTLV-1-Associated Myelopathy (HAM)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MT-3921

Arm Type

Experimental

Arm Description

Intravenous (IV)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intravenous (IV)

Intervention Type

Biological

Intervention Name(s)

MT-3921

Other Intervention Name(s)

Unasnemab

Intervention Description

Solution for infusion; Intravenous (IV)

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Solution for infusion; Intravenous (IV)

Primary Outcome Measure Information:

Title

Percentage of subjects with adverse events

Time Frame

36 weeks

Title

Percentage of subjects with adverse reactions

Time Frame

36 weeks

Title

Serum concentrations of MT-3921

Time Frame

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.

Title

CSF concentrations of MT-3921

Time Frame

PK samples will be collected at 2, 4, 12, 24 weeks post-dose.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

General Manager

Organizational Affiliation

Mitsubishi Tanabe Pharma Corporation

Official's Role

Study Director

Facility Information:

Facility Name

St. Marianna University Hospital

City

Kawasaki-shi

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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