<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/NCT04419259</url>
  </required_header>
  <id_info>
    <org_study_id>ROS031019</org_study_id>
    <nct_id>NCT04419259</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea</brief_title>
  <acronym>STOP Ros</acronym>
  <official_title>An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Messoud Ashina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herlev and Gentofte Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danish Headache Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An exploratory open-label study of rosacea patients to study the efficacy and tolerability of&#xD;
      erenumab in the prophylactic treatment of persistent redness and flushing attributed to&#xD;
      rosacea. Approximately 30 subjects will be included in the study and receive erenumab 140 mg&#xD;
      for three months. The study will begin June 2020 and is expected to last nine months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of erenumab on days of flushing</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 12. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on erythema</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in erythema from Baseline to week 4, 8 and 12. Will be evaluated by Clinicians Erythema Assessment (CEA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on quality of life: Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in quality of life from Baseline to week 4, 8 and 12. Will be evaluated by Dermatology Life Quality Index (DLQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that reach a 50% reduction in number of days with flushing</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on days of flushing</measure>
    <time_frame>8 weeks</time_frame>
    <description>Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 4 and 8. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on depression</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in depressive symptoms from Baseline to week 4, 8 and 12. Evaluated by Hospital Anxiety and Depression Scale (HADS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on overall rosacea symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of patients with Investigator's Global Assessment (IGA) '0' or '1' with an at least 2-point reduction from baseline to week 4, 8 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on inflammatory lesions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that reach a 50% reduction in self-assessed rosacea symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of patients with at least 50% reduction in number of days with Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on self-assessed rosacea symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on depressive symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on overall rosacea severity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in overall rosacea severity from Baseline to week 4, 8 and 12. Evaluated by Rosacea Area and Severity Index (RASI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on rosacea symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in rosacea symptoms from Baseline to week 4, 8 and 12. Evaluated by Rosacea Clinical Scorecard (RCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of erenumab on rosacea-specific quality of life: Rosacea-specific Quality-of-Life index (RosaQoL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean change in rosacea-specific quality of life from Baseline to week 4, 8 and 12. Evaluated by the Rosacea-specific Quality-of-Life index (RosaQoL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tolerability of erenumab in patients with rosacea</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the tolerability of erenumab in patient with rosacea through assessment of adverse events at every visit from Baseline to week 4, 8 and 12.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Erenumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 334</intervention_name>
    <description>30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)</description>
    <arm_group_label>Erenumab</arm_group_label>
    <other_name>Erenumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between ages 18 - 65 years who have suffered from rosacea for at least&#xD;
             12 months.&#xD;
&#xD;
          -  If patient has concurrent migraine, a daily headache diary must be filled out&#xD;
&#xD;
        Criteria to be met prior to enrollment in the 4-week run-in period:&#xD;
&#xD;
        •Erythematotelangiectatic rosacea with a minimum of 15 days of either:&#xD;
&#xD;
          -  PSA &gt; 2, and/or&#xD;
&#xD;
          -  Moderate, severe or extreme flushing measured by the Flushing Assessment Tool (FAST)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic treatment for rosacea ended less than five half-lives or 28 days ago,&#xD;
             whichever is longest&#xD;
&#xD;
          -  Topical treatment for rosacea ended less than five half-lives or 28 days ago,&#xD;
             whichever is longest&#xD;
&#xD;
          -  Cardiovascular disease of any kind, including cerebrovascular disease&#xD;
&#xD;
          -  Hypertension on the experimental day (systolic blood pressure &gt; 150 mmHg and/or&#xD;
             diastolic blood pressure &gt; 100 mmHg)&#xD;
&#xD;
          -  Hypotension on the experimental day (systolic blood pressure &lt; 90 mmHg and/or&#xD;
             diastolic blood pressure &lt; 50 mmHg)&#xD;
&#xD;
          -  Ongoing psychiatric disease of any kind - unless it has been effectively treated with&#xD;
             a stable treatment for at least 2 months.&#xD;
&#xD;
          -  Anamnestic or clinical symptoms of any kind that are deemed relevant for study&#xD;
             participation by the physician who examines the patient&#xD;
&#xD;
          -  Pregnant or breastfeeding women, or women expecting to conceive during the study&#xD;
&#xD;
          -  Women of childbearing potential who are unwilling to use an acceptable method of&#xD;
             effective contraception during treatment through 16 weeks after the last dose of&#xD;
             erenumab. Acceptable methods of effective birth control include not having intercourse&#xD;
             (true abstinence, when this is in line with the preferred and usual lifestyle of the&#xD;
             subject), hormonal birth control methods (pills, shots/injections, implants, or&#xD;
             patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical&#xD;
             assessment of the surgical success of this procedure or bilateral tubal ligation), or&#xD;
             two barrier methods (each partner must use one barrier method) with spermicide - males&#xD;
             must use a condom with spermicide; females must choose either a diaphragm with&#xD;
             spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide.&#xD;
             Female subjects not of childbearing potential are defined as any female who: is&#xD;
             post-menopausal by history, defined as:&#xD;
&#xD;
               -  Age ≥ 55 years with cessation of menses for 12 or more months, OR&#xD;
&#xD;
               -  Age &lt; 55 years but no spontaneous menses for at least 2 years, OR&#xD;
&#xD;
               -  Age &lt; 55 years and spontaneous menses within the past 1 year, but currently&#xD;
                  amenorrhoeic (e.g. spontaneous or secondary to hysterectomy), AND with&#xD;
                  postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating&#xD;
                  hormone levels &gt; 40 IU/L) or postmenopausal estradiol levels (&lt; 5 ng/dL) or&#xD;
                  according to the definition of &quot;postmenopausal range&quot; for the laboratory involved&#xD;
                  OR Underwent bilateral oophorectomy OR Underwent hysterectomy OR Underwent&#xD;
                  bilateral salpingectomy&#xD;
&#xD;
          -  Known sensitivity to any component of erenumab&#xD;
&#xD;
          -  Previously randomized into an erenumab study&#xD;
&#xD;
          -  Member of investigational site staff or relative of the investigator&#xD;
&#xD;
          -  Unlikely to be able to complete all protocol required study visits or procedures,&#xD;
             and/or to comply with all required study procedures to the best of the subject's and&#xD;
             investigator's knowledge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Messoud Ashina, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Headache Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nita KF Wienholtz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Danish Headache Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nita KF Wienholtz, MD</last_name>
    <phone>0045-38634612</phone>
    <email>nita.wienholtz@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Danish Headache Center</name>
      <address>
        <city>Glostrup</city>
        <zip>Dk-2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nita Wienholtz, MD</last_name>
    </contact>
    <investigator>
      <last_name>Messoud Ashina, MD, PhD, DMSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nita Wienholtz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thien Do, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Messoud Ashina</investigator_full_name>
    <investigator_title>Professor, MD, PhD, DMSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
    <mesh_term>Flushing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erenumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04419259
org study id: ROS031019
nct id: NCT04419259
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
An exploratory open-label study of rosacea patients to study the efficacy and tolerability of
      erenumab in the prophylactic treatment of persistent redness and flushing attributed to
      rosacea. Approximately 30 subjects will be included in the study and receive erenumab 140 mg
      for three months. The study will begin June 2020 and is expected to last nine months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of erenumab on days of flushing
time frame: 12 weeks
description: Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 12. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
measure: Effect of erenumab on erythema
time frame: 12 weeks
description: Mean change in erythema from Baseline to week 4, 8 and 12. Will be evaluated by Clinicians Erythema Assessment (CEA)
measure: Effect of erenumab on quality of life: Dermatology Life Quality Index (DLQI)
time frame: 12 weeks
description: Mean change in quality of life from Baseline to week 4, 8 and 12. Will be evaluated by Dermatology Life Quality Index (DLQI)
measure: Proportion of patients that reach a 50% reduction in number of days with flushing
time frame: 12 weeks
description: To evaluate the proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
measure: Effect of erenumab on days of flushing
time frame: 8 weeks
description: Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 4 and 8. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)
measure: Effect of erenumab on depression
time frame: 12 weeks
description: Mean change in depressive symptoms from Baseline to week 4, 8 and 12. Evaluated by Hospital Anxiety and Depression Scale (HADS).
measure: Effect of erenumab on overall rosacea symptoms
time frame: 12 weeks
description: Proportion of patients with Investigator's Global Assessment (IGA) '0' or '1' with an at least 2-point reduction from baseline to week 4, 8 and 12.
measure: Effect of erenumab on inflammatory lesions
time frame: 12 weeks
description: Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12
measure: Proportion of patients that reach a 50% reduction in self-assessed rosacea symptoms
time frame: 12 weeks
description: Proportion of patients with at least 50% reduction in number of days with Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.
measure: Effect of erenumab on self-assessed rosacea symptoms
time frame: 12 weeks
description: Mean change in Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.
measure: Effect of erenumab on depressive symptoms
time frame: 12 weeks
description: Mean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12
measure: Effect of erenumab on overall rosacea severity
time frame: 12 weeks
description: Mean change in overall rosacea severity from Baseline to week 4, 8 and 12. Evaluated by Rosacea Area and Severity Index (RASI)
measure: Effect of erenumab on rosacea symptoms
time frame: 12 weeks
description: Mean change in rosacea symptoms from Baseline to week 4, 8 and 12. Evaluated by Rosacea Clinical Scorecard (RCS)
measure: Effect of erenumab on rosacea-specific quality of life: Rosacea-specific Quality-of-Life index (RosaQoL)
time frame: 12 weeks
description: Mean change in rosacea-specific quality of life from Baseline to week 4, 8 and 12. Evaluated by the Rosacea-specific Quality-of-Life index (RosaQoL)
measure: Tolerability of erenumab in patients with rosacea
time frame: 12 weeks
description: To evaluate the tolerability of erenumab in patient with rosacea through assessment of adverse events at every visit from Baseline to week 4, 8 and 12.
arm group label: Erenumab
arm group type: Experimental
description: 30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
intervention type: Drug
intervention name: AMG 334
description: 30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
arm group label: Erenumab
other name: Erenumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Messoud Ashina, Professor
role: Principal Investigator
affiliation: Danish Headache Center
last name: Nita KF Wienholtz, MD
role: Study Director
affiliation: Danish Headache Center
last name: Nita KF Wienholtz, MD
phone: 0045-38634612
email: nita.wienholtz@regionh.dk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Danish Headache Center
investigator full name: Messoud Ashina
investigator title: Professor, MD, PhD, DMSc
mesh term: Rosacea
mesh term: Flushing
mesh term: Erenumab
sharing ipd: No