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

June 1, 2026 updated by: Actelion

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Investigator Site
      • Lille, France, 59037
        • Investigator Site
      • Nantes, France, 44093
        • Investigator Site
      • Paris, France, 75679
        • Investigator Site
      • Strasbourg, France, 67200
        • Investigator Site
  • Germany
      • Bad Nauheim, Germany, 61231
        • Investigator Site
      • Berlin, Germany, 10117
        • Investigator Site
      • Cologne, Germany, 50937
        • Investigator Site
      • Erlangen, Germany, 91054
        • Investigator Site
      • Magdeburg, Germany, 39120
        • Investigator Site
      • Mainz, Germany, 55131
        • Investigator Site
  • United Kingdom
      • Bath, United Kingdom, BA11RL
        • Investigator Site
      • Leeds, United Kingdom, LS74SA
        • Investigator Site
      • Liverpool, United Kingdom, L97AL
        • Investigator Site
      • London, United Kingdom, NW32QG
        • Investigator Site
      • Salford, United Kingdom, M55AP
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selexipag
Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD.
Drug: Selexipag
Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
Other Names:
  • ACT-293987
Experimental: Placebo
Placebo matching selexipag tablets is administered according to the same schedule as selexipag
Drug: Placebo
Placebo matching selexipag 200 μg tablets to be administered orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From Day 26 to Day 56 ( +/- 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to end of study (Day 86 +/- 7 days)
Number of patients with treatment-emergent serious adverse events
Time Frame: Up to end of study (Day 86 +/- 7 days)
Up to end of study (Day 86 +/- 7 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Chair: Ralph Preiss, MD, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2014

Primary Completion (Actual)

April 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimated)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-065C202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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