HTLV-1-Associated Myelopathy (HAM)Phase 1NCT05240612
A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)
A Phase 1 study testing MT-3921 in people with HTLV-1-Associated Myelopathy (HAM), run by Tanabe Pharma Corporation at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HTLV-1-Associated Myelopathy (HAM)
- What is being tested?
- MT-3921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- 2 May 2022to 28 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacological Study of MT-3921 in Subjects With Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)
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)
- Being tested
- MT-3921, Placebo
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3921Biological
Also called Unasnemab
Solution for infusion; Intravenous (IV)
PlaceboBiological
Solution for infusion; Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| MT-3921 | Experimental | Intravenous (IV) Receives: Biological: MT-3921 |
| Placebo | Placebo comparator | Intravenous (IV) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with adverse events
Measured: 36 weeks
Percentage of subjects with adverse reactions
Measured: 36 weeks
Serum concentrations of MT-3921
Measured: 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
Measured: PK samples will be collected at 2, 4, 12, 24 weeks post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start2 May 2022
- Primary completion14 Sep 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTLV-1-Associated Myelopathy (HAM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240612
- Sponsor's protocol ID
- MT-3921-C-101
- Other IDs
- jRCT2031210616
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of MT-3921 in Subjects With Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)
- ClinicalTrials.gov ID
- NCT05240612
- Acronym / sponsor ID
- MT-3921-C-101
- Conditions
- HTLV-1-Associated Myelopathy (HAM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-3921 | Experimental | Biological: MT-3921Intravenous (IV) |
| Placebo | Placebo comparator | Biological: PlaceboIntravenous (IV) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-3921Also: UnasnemabSolution for infusion; Intravenous (IV) | Biological | MT-3921 |
| PlaceboSolution for infusion; Intravenous (IV) | Biological | Placebo |
Primary outcome
Percentage of subjects with adverse events
Time frame: 36 weeks
Percentage of subjects with adverse reactions
Time frame: 36 weeks
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.
CSF concentrations of MT-3921
Time frame: PK samples will be collected at 2, 4, 12, 24 weeks post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for HTLV-1-Associated Myelopathy (HAM)
RecruitingObservational study
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Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
HAM/TSP
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-3921 in people with HTLV-1-Associated Myelopathy (HAM), run by Tanabe Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with adverse events (time frame: 36 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.