Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneou… (NCT04440592) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
United States76 participantsStarted 2021-02-05
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able to (in the judgment of the Investigator) understand the nature of the study and all risks involved with participation in the study. Subjects must be willing to cooperate and comply with all protocol restrictions and procedures including study visits.
✓. Male or female age ≥ 18 years at screening with documented diagnosis of systemic sclerosis (SSc), as defined using the 2013 ACR/European League Against Rheumatism (EULAR) criteria.
✓. Has diffuse cutaneous form of SSc according to Leroy and Medsger's criteria.
✓. Disease duration ≤ 5 years from the first non-Raynaud's phenomenon manifestation.
✓. Has an mRSS of 15 to 45 units at screening and have clinical skin involvement proximal and distal to the elbows, knees, or both or any truncal involvement, with or without face involvement.
✓. If disease duration is \> 24 months defined as time from the first non Raynaud phenomenon manifestation, subject must fulfill at least 1 of the criteria listed below that are indicatives of active disease at screening:
✓. A documentation of new skin involvement that occurred within the past 9 months, or
✓. Increase in mRSS ≥ 3 units within the past 9 months, or
Exclusion criteria
✕. Has a history or presence of rheumatic autoimmune diseases other than dcSSc unless the dominant features of the disease are dcSSc, as determined by the Investigator.
. Has a pulmonary disease with FVC ≤ 50% of predicted at time of screening.
✕. Has a diagnosis of clinically significant resting pulmonary hypertension (if exceeding estimated right ventricular systolic pressure of \> 40 mmHg estimated by transthoracic echocardiography \[unless the right heart catheterization is normal within the last 6 months\] or mean pulmonary artery pressure \> 30 mmHg as measured by right heart catheterization) and requires treatment with more than one oral medication.
✕. Has a cardiac abnormality such as left ventricular failure with ejection fraction \< 45%, significant arrhythmia, congestive heart failure (New York Heart Association Class II-IV), unstable angina, uncontrolled hypertension, or symptomatic pericardial effusion at screening.
✕. Has a history of myocardial infarction in the last 26 weeks prior to screening.
✕. Has a history of renal crisis within the past 52 weeks prior to screening.
✕. Has a documented history of chronic kidney disease (stage 4-5, an estimated glomerular filtration rate \[eGFR\] \< 30 mL/min at screening).
✕. Presence or history of hepatobiliary disease at screening, determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor.