Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-27 @ 9:49 AM
Study NCT ID:
NCT02260557
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D011928', 'term': 'Raynaud Disease'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523468', 'term': 'selexipag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in quality of life (QOL)', 'timeFrame': 'At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)', 'description': 'QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)'}], 'primaryOutcomes': [{'measure': "Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period", 'timeFrame': 'From Day 26 to Day 56 ( +/- 7 days)', 'description': 'The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).'}], 'secondaryOutcomes': [{'measure': 'Number of patients with treatment-emergent adverse events', 'timeFrame': 'Up to end of study (Day 86 +/- 7 days)', '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'}, {'measure': 'Number of patients with treatment-emergent serious adverse events', 'timeFrame': 'Up to end of study (Day 86 +/- 7 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', "Raynaud's Phenomenon"], 'conditions': ["Raynaud's Phenomenon Secondary to Systemic Sclerosis"]}, 'referencesModule': {'references': [{'pmid': '29193819', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key inclusion criteria:\n\n* Signed informed consent prior to any study-mandated procedure.\n* Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.\n* Women of childbearing potential must agree to use a reliable method of birth control.\n\nKey exclusion criteria:\n\n* Known moderate or severe hepatic impairment (i.e. Child-Pugh C).\n* Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.\n* Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.\n* Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.\n* 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.\n* Severe renal insufficiency (at randomization).\n* 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"}, 'identificationModule': {'nctId': 'NCT02260557', 'briefTitle': "Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis", 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'AC-065C202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selexipag', '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.', 'interventionNames': ['Drug: Selexipag']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo matching selexipag tablets is administered according to the same schedule as selexipag', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Selexipag', 'type': 'DRUG', 'otherNames': ['ACT-293987'], 'description': 'Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily', 'armGroupLabels': ['Selexipag']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching selexipag 200 μg tablets to be administered orally twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ralph Preiss, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Actelion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}