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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intervention / Treatment
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* Drug: Selexipag
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selexipag<br>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<br>* Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily<br>* Other names: ACT-293987;|
| Experimental: Placebo<br>Placebo matching selexipag tablets is administered according to the same schedule as selexipag | Drug: Placebo<br>* Placebo matching selexipag 200 μg tablets to be administered orally twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period | 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 | 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 |  | Up to end of study (Day 86 +/- 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Sclerosis, Raynaud's Phenomenon