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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02260557
• Date of registration: 06/10/2014
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02260557
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Germany, United Kingdom

Contacts

• Name: Ralph Preiss, MD
• Affiliation: Actelion

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intervention(s)

Drug: Placebo

Drug: Selexipag

Primary Outcome(s)

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)]

Secondary Outcome(s)

Number of patients with treatment-emergent adverse events [Time Frame: 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)]

Secondary ID(s)

AC-065C202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors