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

Raynaud's Phenomenon Secondary to Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260557
• Other study ID #: AC-065C202
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2014
• Last updated: May 9, 2016
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Raynaud Disease
• Raynaud's Phenomenon Secondary to Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• Selexipag
Film-coated tablets containing 200 µg of selexipag to be administered orally twice daily
• Placebo
Placebo matching selexipag 200 µg tablets to be administered orally twice daily

Locations

Country	Name	City	State
France	Investigator Site	Grenoble cedex
France	Investigator Site	Lille Cedex
France	Investigator Site	Nantes Cedex 1
France	Investigator Site	Paris
France	Investigator Site	Strasbourg
Germany	Investigator Site	Bad Nauheim
Germany	Investigator Site	Berlin
Germany	Investigator Site	Erlangen
Germany	Investigator Site	Koln
Germany	Investigator Site	Magdeburg
Germany	Investigator Site	Mainz
United Kingdom	Investigator Site	Bath
United Kingdom	Investigator Site	Leeds
United Kingdom	Investigator Site	Liverpool
United Kingdom	Investigator Site	London
United Kingdom	Investigator Site	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in quality of life (QOL)	QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)	At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)	No
Primary	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)	No
Secondary	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)	Yes
Secondary	Number of patients with treatment-emergent serious adverse events		Up to end of study (Day 86 +/- 7 days)	Yes