To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
The ACR CRISS Composite Score (0-1) at Week 52
The comparison between MT-7117 treatment group and placebo group will be performed. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Time frame: Week 52
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52
To evaluate the efficacy of MT 7117 treatment for up to 52 weeks using the Health Assessment Questionnaire Disability Index (HAQ DI). The Health Assessment Questionnaire Disability Index (HAQ-DI) is a self-administered instrument consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement.
Time frame: 52 weeks
Change in Percent Predicted Forced Vital Capacity (%pFVC) From Baseline up to Week 52
To evaluate the efficacy of MT-7117 treatment for up to 52 weeks on pulmonary function as measured by percent predicted forced vital capacity (%pFVC)
Time frame: 52 weeks
Change in Patient Global Assessment From Baseline up to Week 52
To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Patient Global Assessment
Time frame: 52 weeks
Change in Physician Global Assessment From Baseline up to Week 52
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Arizona Arthritis
Glendale, Arizona, United States
Pacific Arthritis Care Center
Los Angeles, California, United States
The Board of Trustees of the Leland Stanford Junior University
Redwood City, California, United States
Yale School of Medicine - The Anlyan Center (TAC) for Medical Research & Education
New Haven, Connecticut, United States
GNP Research
Hollywood, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Shelby Research, LLC
Memphis, Tennessee, United States
...and 24 more locations
To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Physician Global Assessment. The Physician Global Assessment is used to assess the physician's rating of overall health of the subject. Physicians rate the perceived health of the subject on an 11-point scale from 0 (excellent) to 10 (extremely poor).
Time frame: 52 weeks
Change in Modified Rodnan Skin Score (mRSS) From Baseline From Baseline up to Week 52
To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the modified Rodnan Skin Score (mRSS). mRSS evaluates a subject's skin thickness which will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units.
Time frame: 52 weeks
ACR CRISS Score up to Week 39
To evaluate the efficacy of MT 7117 treatment for up to 39 weeks using the ACR CRISS Score. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Time frame: 39 weeks
ACR CRISS Score Responder (CRISS>=0.6) From Baseline up to Week 52
To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using CRISS Score. Subjects with CRISS score is \>=0.60 are considered improved, while subjects with CRISS score \< 0.60 are considered not improved.
Time frame: 52 weeks