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A Study of MT-0551 in Patients With Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status

Recruiting

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Inebilizumab

Placebo

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
Skin thickening score based on the mRTSS between 10 and 22 inclusive.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

Pulmonary hypertension associated with SSc.
Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
Finding of inadequate respiratory reserve capacity.
Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
Presence of a clinically significant active infection requiring antimicrobial therapy.
A past history of cancer.
Past history of a recurrent, clinically significant infection.
Past history of severe allergy or anaphylactic reaction to a biologic drug product.
Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

Sites / Locations

University of Fukui HospitalRecruiting
Kanazawa University HospitalRecruiting
St. Marianna University HospitalRecruiting
The University of Tokyo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-0551 group

Placebo group

Arm Description

Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks.

Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in the mRTSS at Week 26

Secondary Outcome Measures

Pulmonary function tests: Change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)

Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco

Change from baseline in the mRTSS

Composite response index in diffuse cutaneous systemic sclerosis

Full Information

NCT ID

NCT05198557

First Posted

January 6, 2022

Last Updated

September 11, 2023

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05198557

Brief Title

A Study of MT-0551 in Patients With Systemic Sclerosis

Official Title

Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 20, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

July 2026 (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

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.

6. Conditions and Keywords

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

Systemic Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MT-0551 group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Inebilizumab

Other Intervention Name(s)

MT-0551

Intervention Description

Participants will receive IV inebilizumab.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive IV placebo matched to inebilizumab.

Primary Outcome Measure Information:

Title

Change from baseline in the mRTSS at Week 26

Time Frame

Baseline and Week 26

Secondary Outcome Measure Information:

Title

Pulmonary function tests: Change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)

Time Frame

Baseline to at least 52 weeks or early termination

Title

Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco

Time Frame

Baseline to at least 52 weeks or early termination

Title

Change from baseline in the mRTSS

Time Frame

Baseline to at least 52 weeks or early termination

Title

Composite response index in diffuse cutaneous systemic sclerosis

Time Frame

Week 26 to at least 52 weeks or early termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Additional screening criteria check may apply for qualification: ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. Skin thickening score based on the mRTSS between 10 and 22 inclusive. Exclusion Criteria: Additional screening criteria check may apply for qualification: Pulmonary hypertension associated with SSc. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. Finding of inadequate respiratory reserve capacity. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. Presence of a clinically significant active infection requiring antimicrobial therapy. A past history of cancer. Past history of a recurrent, clinically significant infection. Past history of severe allergy or anaphylactic reaction to a biologic drug product. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trials, to prevent miscommunication,

Phone

please e-mail

cti-inq-ml@ml.mt-pharma.co.jp

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

University of Fukui Hospital

City

Yoshida-gun

State/Province

Fukui

ZIP/Postal Code

910-1193

Country

Japan

Individual Site Status

Recruiting

Facility Name

Kanazawa University Hospital

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

Individual Site Status

Recruiting

Facility Name

St. Marianna University Hospital

City

Kawasaki-shi

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Individual Site Status

Recruiting

Facility Name

The University of Tokyo Hospital

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of MT-0551 in Patients With Systemic Sclerosis

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