Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (NCT01474109) | Clinical Trial Compass
CompletedPhase 3
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
United States, Australia, Belarus289 participantsStarted 2011-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* 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
Exclusion Criteria :
* 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 modifyin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rate of New Digital Ulcers (DUs) up to Week 16