Bosentan in Systemic Sclerosis

The effect of bosentan on digital ulcers (DU) was studied in two randomized placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the heterogeneous study population. More importantly, there were no endpoints that assessed changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to effectively demonstrate blood flow restrictions in the hands of patients with Systemic Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser Doppler imaging and the extent of DU disease has not been studied. The current study will attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2 years and a clinically relevant reduction of blood flow in the hands, will be assessed.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Digital Ulcers Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VUmc, Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female subjects > 18 years diagnosed with SSc;
Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to the healthy volunteers;
Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
A history of 1 or more DUs within 2 years prior to inclusion;
No use of bosentan in the past;
Subjects willing and able to sign informed consent.

Exclusion criteria

Parenteral prostanoid treatment for DU < 3 months ago;
Chronic treatment with PDE-5 inhibitor or ERA;
History of bosentan use
Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
Other types of system- or connective tissue diseases;
Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
Moderate to severe liver function disorder;
Pregnancy or breastfeeding;
Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
Hypersensitivity for bosentan or one of its components;
Subjects not able to follow the protocol.

Treatment and study plan

Bosentan

Drug

2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.

Primary outcomes

Mean blood flow restriction in patients

Time frame: Baseline to 12 weeks

Relationship between blood flow in the hands, as measured by laser Doppler imaging, and extent of Digital Ulcer disease assessed by the mean blood flow restriction in four distinct groups of patients: patients without current Digital Ulcers (pitting scars allowed), patients with new Digital Ulcers (< 3 months), patients with persistent Digital Ulcers (> 3 months) and patients with significant tip-necrosis.

Secondary outcomes

Change in blood flow in the hands

Time frame: Baseline to 12 weeks of bosentan treatment

Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands

Acronym: HOME

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 18, 2011
Registry last updated: Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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