Raynaud's Phenomenon Secondary to Systemic Sclerosis
Conditions
Keywords
Systemic Sclerosis, Raynaud's Phenomenon
Brief summary
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).
Interventions
DRUGSelexipag
Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
DRUGPlacebo
Placebo matching selexipag 200 μg tablets to be administered orally twice daily
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period | From Day 26 to Day 56 ( +/- 7 days) | The number of RP attacks is determined from daily entries in electronic Diaries (eDiary). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment-emergent adverse events | 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 |
| Number of patients with treatment-emergent serious adverse events | Up to end of study (Day 86 +/- 7 days) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in quality of life (QOL) | At baseline (Day 1) and end of treatment (Day 56 +/- 7 days) | QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ) |
Outcome results
None listed