Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Sclerosis, Ulcers

In brief

The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include: * the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. * the evaluation of the safety and tolerability of macitentan in these patients. * the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.

Key facts

Study ID: NCT01474109
Run by: Actelion
People needed: 289
Starts: 2011-12-01
Expected to finish: 2013-11-01
Last updated by the study team: 2015-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients ≥ 18 years of age
Women of childbearing potential must use two reliable methods of contraception
Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR)
At least one visible, active ischemic digital ulcers (DU) at baseline
History of at least one additional recent active ischemic DU

You may not qualify if…

DUs due to condition other than SSc
Symptomatic Pulmonary arterial hypertension (PAH)
Body mass index (BMI) < 18 kg/m\^2
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x upper limit of the normal range (ULN)
Hemoglobin < 75% of the lower limit of the normal range
Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg
Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition.
Females who are pregnant or breastfeeding or plan to do so during the course of this study.
Substance or alcohol abuse or dependence, or tobacco use at any level.
Treatment with phosphodiesterase type-5 (PDE5) inhibitors.
Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period.
Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period.
Treatment with prostanoids within 3 months.
Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening.
Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent).
Treatment with ERAs within 3 months.
Systemic antibiotics to treat infected DU(s) within 4 weeks.

Where it is running

UCLA Medical School - Rheumatology Division Rehabilitation Center — Los Angeles, California, United States
Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
Sarasota Arthritis Research Center — Sarasota, Florida, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
University of Michigan - Scleroderma Program — Ann Arbor, Michigan, United States
Michigan State University — Grand Rapids, Michigan, United States
University of Medicine & Dentistry of New Jersey, UMDNJ Scleroderma Program — New Brunswick, New Jersey, United States
The Center for Rheumatology — Albany, New York, United States
Shanahan Rheumatology and Immunotherapy, PLLC — Raleigh, North Carolina, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
University of Pittsburgh Department of Rheumatology — Pittsburgh, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Royal Adelaide Hospital — Adelaide, Australia
Wesley Hospital, Thoracic Department — Auchenflower, Australia
Royal Prince Alfred Hospital — Camperdown, Australia
St Vincent's Hospital — Fitzroy, Australia
Menzies Research Institute — Hobart, Australia
Gomel Regional Clinical Hospital — Homyel, Belarus
Healthcare Institution "Minsk City Hospital #1" — Minsk, Belarus
Healthcare Institution "Minsk Clinical Hospital #9" — Minsk, Belarus
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon" — Pleven, Bulgaria
MHAT "Kaspela" EOOD Plovdiv - Rheumatology Ward — Plovdiv, Bulgaria
University of Arizona Arthritis Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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