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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis

Treatments: Drug: Selexipag; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260557

AC-065C202

Details and patient eligibility

About

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).

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups

Selexipag

Experimental group

Description:

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.

Treatment:

Drug: Selexipag

Placebo

Experimental group

Description:

Placebo matching selexipag tablets is administered according to the same schedule as selexipag

Treatment:

Drug: Placebo