search
Back to results

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

Primary Purpose

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selexipag
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Phenomenon Secondary to Systemic Sclerosis focused on measuring Systemic Sclerosis, Raynaud's Phenomenon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Selexipag

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Number of patients with treatment-emergent serious adverse events

Full Information

First Posted
October 6, 2014
Last Updated
May 9, 2016
Sponsor
Actelion
search

1. Study Identification

Unique Protocol Identification Number
NCT02260557
Brief Title
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Keywords
Systemic Sclerosis, Raynaud's Phenomenon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selexipag
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo matching selexipag tablets is administered according to the same schedule as selexipag
Intervention Type
Drug
Intervention Name(s)
Selexipag
Other Intervention Name(s)
ACT-293987
Intervention Description
Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching selexipag 200 μg tablets to be administered orally twice daily
Primary Outcome Measure Information:
Title
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
Description
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
Time Frame
From Day 26 to Day 56 ( +/- 7 days)
Secondary Outcome Measure Information:
Title
Number of patients with treatment-emergent adverse events
Description
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
Time Frame
Up to end of study (Day 86 +/- 7 days)
Title
Number of patients with treatment-emergent serious adverse events
Time Frame
Up to end of study (Day 86 +/- 7 days)
Other Pre-specified Outcome Measures:
Title
Change from baseline in quality of life (QOL)
Description
QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)
Time Frame
At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Preiss, MD
Organizational Affiliation
Actelion
Official's Role
Study Chair
Facility Information:
Facility Name
Investigator Site
City
Grenoble cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Investigator Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigator Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Investigator Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Investigator Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Investigator Site
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Investigator Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigator Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Investigator Site
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Investigator Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Investigator Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Investigator Site
City
Bath
ZIP/Postal Code
BA11RL
Country
United Kingdom
Facility Name
Investigator Site
City
Leeds
ZIP/Postal Code
LS74SA
Country
United Kingdom
Facility Name
Investigator Site
City
Liverpool
ZIP/Postal Code
L97AL
Country
United Kingdom
Facility Name
Investigator Site
City
London
ZIP/Postal Code
NW32QG
Country
United Kingdom
Facility Name
Investigator Site
City
Salford
ZIP/Postal Code
M55AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29193819
Citation
Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs