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

Sponsor

Actelion (Industry)

Overall Status

Completed

CT.gov ID

NCT02260557

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Raynaud's Phenomenon Secondary to Systemic Sclerosis	Drug: Selexipag Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selexipag 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 Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily Other Names: ACT-293987
Experimental: Placebo Placebo matching selexipag tablets is administered according to the same schedule as selexipag	Drug: Placebo Placebo matching selexipag 200 μg tablets to be administered orally twice daily

Arm

Intervention/Treatment

Experimental: Selexipag

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

Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily

Other Names:

ACT-293987

Experimental: Placebo

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

Drug: Placebo

Placebo matching selexipag 200 μg tablets to be administered orally twice daily

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Investigator Site	Grenoble cedex	France	38043
2	Investigator Site	Lille Cedex	France	59037
3	Investigator Site	Nantes Cedex 1	France	44093
4	Investigator Site	Paris	France	75679
5	Investigator Site	Strasbourg	France	67200
6	Investigator Site	Bad Nauheim	Germany	61231
7	Investigator Site	Berlin	Germany	10117
8	Investigator Site	Erlangen	Germany	91054
9	Investigator Site	Koln	Germany	50937
10	Investigator Site	Magdeburg	Germany	39120
11	Investigator Site	Mainz	Germany	55131
12	Investigator Site	Bath	United Kingdom	BA11RL
13	Investigator Site	Leeds	United Kingdom	LS74SA
14	Investigator Site	Liverpool	United Kingdom	L97AL
15	Investigator Site	London	United Kingdom	NW32QG
16	Investigator Site	Salford	United Kingdom	M55AP