<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260557</url>
  </required_header>
  <id_info>
    <org_study_id>AC-065C202</org_study_id>
    <nct_id>NCT02260557</nct_id>
  </id_info>
  <brief_title>Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actelion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Actelion</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the activity of selexipag on Raynaud&#xD;
      attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis&#xD;
      (SSc).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period</measure>
    <time_frame>From Day 26 to Day 56 ( +/- 7 days)</time_frame>
    <description>The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with treatment-emergent adverse events</measure>
    <time_frame>Up to end of study (Day 86 +/- 7 days)</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with treatment-emergent serious adverse events</measure>
    <time_frame>Up to end of study (Day 86 +/- 7 days)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in quality of life (QOL)</measure>
    <time_frame>At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)</time_frame>
    <description>QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Raynaud's Phenomenon Secondary to Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>Selexipag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo matching selexipag tablets is administered according to the same schedule as selexipag</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selexipag</intervention_name>
    <description>Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily</description>
    <arm_group_label>Selexipag</arm_group_label>
    <other_name>ACT-293987</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching selexipag 200 μg tablets to be administered orally twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key inclusion criteria:&#xD;
&#xD;
          -  Signed informed consent prior to any study-mandated procedure.&#xD;
&#xD;
          -  Male and female subjects aged 18 years and above with a history of recurrent multiple&#xD;
             weekly RP attacks secondary to SSc.&#xD;
&#xD;
          -  Women of childbearing potential must agree to use a reliable method of birth control.&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
          -  Known moderate or severe hepatic impairment (i.e. Child-Pugh C).&#xD;
&#xD;
          -  Known hypersensitivity to selexipag or drugs of the same class, or any of their&#xD;
             excipients.&#xD;
&#xD;
          -  Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e.,&#xD;
             treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.&#xD;
&#xD;
          -  Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week&#xD;
             prior to the screening visit.&#xD;
&#xD;
          -  Any dose change or initiation of any of the following drugs within 1 month prior to&#xD;
             the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's,&#xD;
             Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin&#xD;
             Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic&#xD;
             corticosteroids, Fluoxetine.&#xD;
&#xD;
          -  Severe renal insufficiency (at randomization).&#xD;
&#xD;
          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect&#xD;
             the subject's full participation in the study or compliance with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ralph Preiss, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Actelion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Grenoble cedex</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Nantes Cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Koln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Bath</city>
        <zip>BA11RL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Leeds</city>
        <zip>LS74SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L97AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>London</city>
        <zip>NW32QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Salford</city>
        <zip>M55AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>May 9, 2016</last_update_submitted>
  <last_update_submitted_qc>May 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Sclerosis</keyword>
  <keyword>Raynaud's Phenomenon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Raynaud Disease</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Selexipag</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260557
org study id: AC-065C202
nct id: NCT02260557
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
time frame: From Day 26 to Day 56 ( +/- 7 days)
description: The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
measure: Number of patients with treatment-emergent adverse events
time frame: 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
time frame: Up to end of study (Day 86 +/- 7 days)
measure: Change from baseline in quality of life (QOL)
time frame: At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)
description: QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)
arm group label: Selexipag
arm group type: Experimental
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 group label: Placebo
arm group type: Experimental
description: Placebo matching selexipag tablets is administered according to the same schedule as selexipag
intervention type: Drug
intervention name: Selexipag
description: Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
arm group label: Selexipag
other name: ACT-293987
intervention type: Drug
intervention name: Placebo
description: Placebo matching selexipag 200 μg tablets to be administered orally twice daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ralph Preiss, MD
role: Study Chair
affiliation: Actelion
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
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country: France
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Raynaud Disease
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
mesh term: Selexipag