A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2014-000865-34-DE
• Date of registration: 10/09/2014
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis
• Scientific 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
• Date of first enrolment: 31/10/2014
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000865-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Run-in period: single-blind placebo If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany, United Kingdom

Contacts

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
At Screening visit:
• Signed informed consent prior to any study-mandated procedure.
• Male and female subjects aged 18 years and above with history of
recurrent multiple weekly RP attacks secondary to SSc.
• A woman of childbearing potential is eligible only if the following
applies:
-Negative urine pregnancy test at screening visit.
-Agreement to undertake monthly pregnancy tests during the
study and up to 30 days after study treatment discontinuation.
-Agreement to use one reliable method of birth control

At randomization visit all the above apply and:
• Subjects with RP who have experienced at least 7 RP attacks in the 7 days prior to the randomization visit (i.e., baseline week) with attacks on at least 5 different days.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
At screening visit:
• Known 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 or are scheduled to receive any of
those treatments during the intended study period.
• Subjects who have received a Phosphodiesterase type 5 (PDE-5)
inhibitor within 1 week prior to the screening visit or are scheduled
to receive any such treatment during the intended study period.
• Any dose change or initiation of any of the following drugs within 1
month prior to the screening visit:
oCalcium channel blockers
oNitrates or nitric oxide donors
oERA's
oAlpha-blockers
oAntithrombotic agents
oNSAIDs (occasional use allowed)
oAngiotensin Converting Enzyme (ACE) inhibitors
oBeta-blockers
oClonidine
oSystemic corticosteroids
oFluoxetine

At randomization visit all the above apply and:
• Severe renal insufficiency: estimated creatinine clearance <30
mL/min/1.73 m² or serum creatinine >2.5 mg/dL (221 µmol/L)
based on central laboratory results from screening visit blood sample
• Subjects who were not compliant with run-in procedures




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Product Name: Selexipag
Product Code: ACT-293987
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Selexipag
Current Sponsor code: ACT-293987
Other descriptive name: SELEXIPAG
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is the average weekly number of RP attacks during maintenance period as determined from daily entries in electronic Diaries (eDiary).

Timepoint(s) of evaluation of this end point: NA

Secondary Objective: • to explore the effect of selexipag in reducing the impact of RP on subject's Quality of Life (QoL).
• to assess the safety and tolerability of selexipag in subjects with RP secondary to SSc.
• to explore relationships between plasma concentration of selexipag and its metabolite ACT-333679 to IP receptor activation or SSc biomarkers

Main Objective: 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).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

2014-000865-34-GB

AC-065C202

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd