A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis(scleroderma)

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. - DUAL-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002684

Enrollment

285

Registered

2012-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Digital Ulcers Associated with Systemic Sclerosis.

Interventions

Intervention1: Macitentan: Macitentan 10mg q.d up to 25 months, oral. Intervention2: Macitentan: Macitentan 3mg q.d upto 25 months, oral. Control Intervention1: Placebo: Placebo q.d upto 25 months, or

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR), or having ever met criteria for CREST syndrome (with sclerodactyly and 2 out of the 4 remaining criteria: calcinosis,raynauds phenomenon, esophageal dysfunction, telangiectasia). 2.At least one visible, active ischemic DU at baseline, located at or distal to the proximal interphalangeal joints (PIP) or at the digital tip, and that developed or worsened within 8 weeks prior to sreening. 3.History of at least one additional active ischemic DU within 6 months, or at least two within 12 months prior to Screening

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.DUs due to condition other than SSc. 2.Symptomatic pulmonary arterial hypertension (PAH). 3.Body mass index (BMI: kg/m2) less than 18. 4.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal (ULN). 5.Hemoglobin less than 75 percent of the lower limit of the normal range. 6.Systolic blood pressure less than 95 mmHg or diastolic blood pressure less than 50mmHg. 7.Severe malabsorption, any severe organ failure (e.g., lung, kidney), or any life-threatening condition. 8.Comorbidities, other than SSc, that could seriously affect the assessment of hand function. 9.Females who are pregnant or breastfeeding or plan to do so during the course of this study. 10.Substance or alcohol abuse or dependence, or tobacco use. 11.Treatment with PDE5 inhibitors (e.g., sildenafil, tadalafil). 12.Patients on statins (e.g., atorvastatin, simvastatin), who have received treatment for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable during this period. 13.Patients on vasodilators, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment for less than 2 weeks prior to Screening (Visit 1) or whose treatment has not been stable during this period. 14.Treatment with prostanoids. 15.Treatment with disease modifying agents such as methotrexate and cyclophosphamide if present for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable for at least 1 month prior to Screening (Visit 1).

Design outcomes

Primary

Measure	Time frame
Cumulative number of new ulcers on the finger .Timepoint: Cumulative number of new ulcers on the finger.	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

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

Contacts

Public ContactChristo Mannil

Krishna Institute of Medical Sciences Ltd

sarath10@hotmail.com9866000685

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026