Systemic Lupus ErythematosusPhase 1NCT02307643
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
A Phase 1 study testing MT-1303 Low dose and MT-1303 High dose in people with Systemic Lupus Erythematosus, run by Tanabe Pharma Corporation at 14 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MT-1303 Low dose and MT-1303 High dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 14 sitesJapan
- Study dates
- Feb 2015to May 2017
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
- Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
- Stable doses of corticosteroids
Who cannot join
- Severe active lupus nephritis, neuropsychiatric SLE
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Inverstigational site
Bunkyō City
Inverstigational site
Chiba
Inverstigational site
Chūōku
Inverstigational site
Fuchu-shi
Investigational site
Fukuoka
Inverstigational site
Kawagoe-shi
Inverstigational site
Maebashi
Inverstigational site
Meguro-ku
Investigational site
Narashino-shi
Investigational site
Sendai
Inverstigational site
Shimotsuga-gun
Inverstigational site
Shinjuku-ku
Inverstigational site
Tsukuba
Investigational site
Urayasu-shi
About this study
Official title: An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)
The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MT-1303 Low dose, MT-1303 High dose
- Keywords
- Systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-1303 Low doseDrug
MT-1303 High doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | MT-1303 Low dose+Corticosteroid Receives: Drug: MT-1303 Low dose |
| Part 2-A | Experimental | MT-1303 High dose+Corticosteroid Receives: Drug: MT-1303 High dose |
| Part 2-B | Experimental | MT-1303 Low dose+Corticosteroid+Immunosuppressant Receives: Drug: MT-1303 Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Adverse Events
Measured: up to 36 weeks
Secondary outcomes (2)
Change from Baseline in anti-dsDNA and complement
Measured: baseline and 24 weeks
Change from Baseline in Lymphocyte counts
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsutomu Takeuchi, MD, Study chair, Keio University HospitalYoshiya Tanaka, MD, Study director, University of Occupational and Environmental HealthKazuoki Kondo, MD, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307643
- Sponsor's protocol ID
- MT-1303-J03
- Status last verified
- Jun 2017
- First submitted
- 18 Nov 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tanaka Y, Kondo K, Ichibori A, Yanai Y, Susuta Y, Inoue S, Takeuchi T. Amiselimod, a sphingosine 1-phosphate receptor-1 modulator, for systemic lupus erythematosus: A multicenter, open-label exploratory study. Lupus. 2020 Dec;29(14):1902-1913. doi: 10.1177/0961203320966385. Epub 2020 Oct 28.
PubMed 33115374
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)
- ClinicalTrials.gov ID
- NCT02307643
- Acronym / sponsor ID
- MT-1303-J03
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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 purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: MT-1303 Low doseMT-1303 Low dose+Corticosteroid |
| Part 2-A | Experimental | Drug: MT-1303 High doseMT-1303 High dose+Corticosteroid |
| Part 2-B | Experimental | Drug: MT-1303 Low doseMT-1303 Low dose+Corticosteroid+Immunosuppressant |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
- Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
- Stable doses of corticosteroids
Key exclusion criteria (1 listed)
- Severe active lupus nephritis, neuropsychiatric SLE
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-1303 Low dose | Drug | Part 1, Part 2-B |
| MT-1303 High dose | Drug | Part 2-A |
Primary outcome
Number of Subjects with Adverse Events
Time frame: up to 36 weeks
2 secondary outcomes
Change from Baseline in anti-dsDNA and complement
Time frame: baseline and 24 weeks
Change from Baseline in Lymphocyte counts
Time frame: baseline and 24 weeks
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 14 Jun 2017.
- Derived from this study: PubMed 33115374Tanaka Y, Kondo K, Ichibori A, Yanai Y, Susuta Y, Inoue S, Takeuchi T. Amiselimod, a sphingosine 1-phosphate receptor-1 modulator, for systemic lupus erythematosus: A multicenter, open-label exploratory study. Lupus. 2020 Dec;29(14):1902-1913. doi: 10.1177/0961203320966385. Epub 2020 Oct 28.
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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.
Tsutomu Takeuchi, MD study chair
Keio University Hospital
Yoshiya Tanaka, MD study director
University of Occupational and Environmental Health
Kazuoki Kondo, MD study director
Tanabe Pharma Corporation
14 sites 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-1303 Low dose and MT-1303 High dose in people with Systemic Lupus Erythematosus, run by Tanabe Pharma Corporation at 14 sites 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 3 inclusion and 1 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. 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?
Number of Subjects with Adverse Events (time frame: up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307643, which also lists 1 linked publication.
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 14 Jun 2017.