Trial record 1 of 979 for:    DUAL-2
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Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (DUAL-2)

This study has been terminated.
(company decision)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01474122
First received: October 31, 2011
Last updated: April 29, 2014
Last verified: April 2014

October 31, 2011
April 29, 2014
December 2011
February 2014   (final data collection date for primary outcome measure)
cumulative number of digital ulcers up to week 16 [ Time Frame: Period1: baseline (visit 2) to week 16. Period2: week 16 to end of study (which will occur when the last randomized patient, not prematurely withdrawn, has completed Period 1 and a 30 day safety follow-up period) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474122 on ClinicalTrials.gov Archive Site
hand functionality assessed through HDISS-DU PRO and HAQ-DI [ Time Frame: Period1: baseline (visit 2) to week 16. Period2: week 16 to end of study (which will occur when the last randomized patient, not prematurely withdrawn, has completed Period 1 and a 30 day safety follow-up period) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Prospective, Randomized, Placebo-controlled, Double-blind, Mutlicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Schemic Digital Ulcers Associated With Systemic Sclerosis

The DUAL-2 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 (DU).

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.

Recurrent digital ulcers (DU) are a manifestation of vascular disease in patients with systemic sclerosis (SSc), are an important source of morbidity and lead to impaired function in these patients. In this study, we are investigating whether treatment with the endothelin receptor antagonist, macitentan, decreases the development of new digital ulcers in patients with SSc. Macitentan is a highly potent, tissue-targeting dual endothelin receptor antagonist. Through complete blockade of endothelin action, macitentan is expected to protect tissue from the damaging effect of elevated endothelin. This therapy is not approved for the treatment of systemic sclerosis, but the use of an ERA is an attractive approach in combating the structural vascular damage observed in SSc leading to complications such as DUs.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Systemic Sclerosis
  • Ulcers
  • Drug: macitentan 3mg
    macitentan tablet 3mg once daily
    Other Name: ACT-064992
  • Drug: macitentan 10mg
    macitentan tablet 10mg once daily
    Other Name: ACT-064992
  • Drug: placebo
    matching placebo once daily
    Other Name: placebo
  • Active Comparator: macitentan 3mg
    macitentan tablet 3mg once daily
    Intervention: Drug: macitentan 3mg
  • Placebo Comparator: placebo
    matching placebo once daily
    Intervention: Drug: placebo
  • Active Comparator: macitentan 10mg
    macitentan tablet 10mg once daily
    Intervention: Drug: macitentan 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
265
February 2014
February 2014   (final data collection date for primary outcome measure)

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 DU at baseline
  • History of at least one additional recent active ischemic digital ulcers(DU)

Exclusion Criteria :

  • DUs due to condition other than SSc
  • Symptomatic PAH
  • BMI < 18 kg/m2
  • AST and/or ALT > 1.5 x 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 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   China,   Colombia,   Germany,   Greece,   Ireland,   Israel,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom
 
NCT01474122
AC-055C302
Yes
Actelion
Actelion
Not Provided
Not Provided
Actelion
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP