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Completed

NCT Number: NCT02260557

Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

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Key information

Conditions

Raynaud's Phenomenon Secondary to Systemic Sclerosis Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site, Grenoble, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key inclusion criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
  • Women of childbearing potential must agree to use a reliable method of birth control.

Key exclusion criteria:

  • Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
  • Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
  • Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
  • Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
  • Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
  • Severe renal insufficiency (at randomization).
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Treatment and study plan

Selexipag

Drug

Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily

Other names: ACT-293987

Placebo

Drug

Placebo matching selexipag 200 μg tablets to be administered orally twice daily

Primary outcomes

  1. Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period

    Time frame: From Day 26 to Day 56 ( +/- 7 days)

    The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).

Secondary outcomes

  1. Number of patients with treatment-emergent adverse events

    Time frame: Up to end of study (Day 86 +/- 7 days)

    A treatment-emergent adverse event is any adverse event (AE) temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests

  2. Number of patients with treatment-emergent serious adverse events

    Time frame: Up to end of study (Day 86 +/- 7 days)

Other outcomes

  1. Change from baseline in quality of life (QOL)

    Time frame: At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)

    QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2014
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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