Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01474109
• Date of registration: 31/10/2011
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients DUAL-1
• Scientific title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis
• Date of first enrolment: December 2011
• Target sample size: 289
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01474109
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Belarus, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, Germany, Hungary, India, Italy, Poland, Russian Federation, Ukraine, United States

Key inclusion & exclusion criteria

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 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Ulcers

Intervention(s)

Drug: macitentan 3mg

Drug: placebo

Drug: macitentan 10mg

Primary Outcome(s)

Incidence Rate of New Digital Ulcers (DUs) up to Week 16 [Time Frame: Baseline to week 16]

Secondary Outcome(s)

Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16 [Time Frame: Baseline to week 16]

Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16 [Time Frame: Baseline to week 16]

Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16 [Time Frame: Baseline to week 16]

Percentage of Participants With at Least One DU Complication [Time Frame: Up to approximately 90 weeks]

Percentage of Participants Without a New DU Up To Week 16 [Time Frame: Baseline to week 16]

Secondary ID(s)

AC-055C301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01474109