Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

NCT ID: NCT02307643

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1

MT-1303 Low dose+Corticosteroid

Group Type EXPERIMENTAL

MT-1303 Low dose

Intervention Type DRUG

Part 2-A

MT-1303 High dose+Corticosteroid

Group Type EXPERIMENTAL

MT-1303 High dose

Intervention Type DRUG

Part 2-B

MT-1303 Low dose+Corticosteroid+Immunosuppressant

Group Type EXPERIMENTAL

MT-1303 Low dose

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MT-1303 Low dose

Intervention Type DRUG

MT-1303 High dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Severe active lupus nephritis, neuropsychiatric SLE
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tsutomu Takeuchi, MD

Role: STUDY_CHAIR

Keio University Hospital

Yoshiya Tanaka, MD

Role: STUDY_DIRECTOR

University of Occupational and Environmental Health

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inverstigational site

Bunkyō City, , Japan

Site Status

Inverstigational site

Chiba, , Japan

Site Status

Inverstigational site

Chūōku, , Japan

Site Status

Inverstigational site

Fuchu-shi, , Japan

Site Status

Investigational site

Fukuoka, , Japan

Site Status

Inverstigational site

Kawagoe-shi, , Japan

Site Status

Inverstigational site

Maebashi, , Japan

Site Status

Inverstigational site

Meguro-ku, , Japan

Site Status

Investigational site

Narashino-shi, , Japan

Site Status

Investigational site

Sendai, , Japan

Site Status

Inverstigational site

Shimotsuga-gun, , Japan

Site Status

Inverstigational site

Shinjuku-ku, , Japan

Site Status

Inverstigational site

Tsukuba, , Japan

Site Status

Investigational site

Urayasu-shi, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33115374 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MT-1303-J03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of GR1803 in Systemic Lupus Erythematosus
NCT07348055 RECRUITING PHASE1/PHASE2