Clinical trial NCT02260557: Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis
Keywords: Systemic Sclerosis
Raynaud's Phenomenon
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
timeFrame: From Day 26 to Day 56 ( +/- 7 days)
Secondary outcomes:
measure: Number of patients with treatment-emergent adverse events
timeFrame: Up to end of study (Day 86 +/- 7 days)
measure: Number of patients with treatment-emergent serious adverse events
timeFrame: Up to end of study (Day 86 +/- 7 days)
Other outcomes:
measure: Change from baseline in quality of life (QOL)
timeFrame: At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)
Locations:
Study officials:
affiliation: Actelion
name: Ralph Preiss, MD
role: STUDY_CHAIR
References:
citation: Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.