Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Systemic Sclerosis, Pulmonary; Hypertension

In brief

A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients. The study will determine safety and the primary outcome variability for DMF in treating SSc-PAH; the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance (6MWD).

Key facts

Study ID

NCT02981082

Run by

Robert Lafyatis

People needed

6

Starts

2016-12-01

Expected to finish

2020-02-10

Last updated by the study team

2022-03-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed inform consent prior to any study-mandated procedures
• Adult patients 18-80 years of age
• World Health Organization Group 1 PAH associated with scleroderma (SSc-PAH)
• WHO functional Class II-III
• 6MWD 150 to 450 meters
• Right heart catheterization demonstrating mPAP≥ 25 mmHg and PCWP or left ventricular end diastolic pressure ≤15mm Hg and pulmonary vascular resistance ≥240 dynes/cm-5 (3 Wood units) within 12 weeks prior to study entry.
• ACR defined systemic sclerosis

You may not qualify if…

• Pulmonary hypertension associated with
• PAH of any etiology other than scleroderma
• PH of any etiology other than WHO Group I PAH
• Pulmonary venous hypertension defined as PCWP or LVEDP >15 mHg
• Untreated sleep apnea with AHI >20 or SaO2 Nadir <87%
• Chronic thromboembolic disease
• Sarcoidosis
• Participation in a clinical investigational study within the previous 30 days
• Moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C)
• Renal failure defined as:
• estimated creatinine clearance <30 m/min
• serum creatinine>2.5 mg/dl
• Serum aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal
• Systolic blood pressure < 90mmHg
• Recently started (< 8 weeks prior to randomization) or planned cardiopulmonary rehabilitation program based on exercise
• Pregnant or lactating women
• Need for HAART therapy
• Planned treatment or treatment with another investigational drug within 1 month prior to start
• Moderate to severe interstitial lung disease, defined by FVC < 80% or evidence on HRCT of fibrosis or ground glass changes involving more than 30% of lung parenchyma

Where it is running

• National Jewish — Denver, Colorado, United States
• John Hopkins — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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