Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selexipag | Experimental | 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 | Experimental | Placebo matching selexipag tablets is administered according to the same schedule as selexipag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selexipag | Drug | Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Key inclusion criteria:
Key exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ralph Preiss, MD | Actelion | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Grenoble | 38043 | France | |||
| Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29193819 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching selexipag 200 μg tablets to be administered orally twice daily |
|
| Number of patients with treatment-emergent serious adverse events | Up to end of study (Day 86 +/- 7 days) |
| Lille |
| 59037 |
| France |
| Investigator Site | Nantes | 44093 | France |
| Investigator Site | Paris | 75679 | France |
| Investigator Site | Strasbourg | 67200 | France |
| Investigator Site | Bad Nauheim | 61231 | Germany |
| Investigator Site | Berlin | 10117 | Germany |
| Investigator Site | Cologne | 50937 | Germany |
| Investigator Site | Erlangen | 91054 | Germany |
| Investigator Site | Magdeburg | 39120 | Germany |
| Investigator Site | Mainz | 55131 | Germany |
| Investigator Site | Bath | BA11RL | United Kingdom |
| Investigator Site | Leeds | LS74SA | United Kingdom |
| Investigator Site | Liverpool | L97AL | United Kingdom |
| Investigator Site | London | NW32QG | United Kingdom |
| Investigator Site | Salford | M55AP | United Kingdom |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
Not provided
Not provided
| ID | Term |
|---|---|
| C523468 | selexipag |
Not provided
Not provided
Not provided