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Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea (STOP Ros)

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ClinicalTrials.gov Identifier: NCT04419259
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Danish Headache Center
Novartis Pharmaceuticals
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Messoud Ashina, Danish Headache Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: AMG 334 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea
Actual Study Start Date : June 9, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Erenumab
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)
Drug: AMG 334
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)
Other Name: Erenumab




Primary Outcome Measures :
  1. Effect of erenumab on days of flushing [ Time Frame: 12 weeks ]
    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)


Secondary Outcome Measures :
  1. Effect of erenumab on erythema [ Time Frame: 12 weeks ]
    Mean change in erythema from Baseline to week 4, 8 and 12. Will be evaluated by Clinicians Erythema Assessment (CEA)

  2. Effect of erenumab on quality of life: Dermatology Life Quality Index (DLQI) [ Time Frame: 12 weeks ]
    Mean change in quality of life from Baseline to week 4, 8 and 12. Will be evaluated by Dermatology Life Quality Index (DLQI)

  3. Proportion of patients that reach a 50% reduction in number of days with flushing [ Time Frame: 12 weeks ]
    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)

  4. Effect of erenumab on days of flushing [ Time Frame: 8 weeks ]
    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)

  5. Effect of erenumab on depression [ Time Frame: 12 weeks ]
    Mean change in depressive symptoms from Baseline to week 4, 8 and 12. Evaluated by Hospital Anxiety and Depression Scale (HADS).

  6. Effect of erenumab on overall rosacea symptoms [ Time Frame: 12 weeks ]
    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.

  7. Effect of erenumab on inflammatory lesions [ Time Frame: 12 weeks ]
    Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12

  8. Proportion of patients that reach a 50% reduction in self-assessed rosacea symptoms [ Time Frame: 12 weeks ]
    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.

  9. Effect of erenumab on self-assessed rosacea symptoms [ Time Frame: 12 weeks ]
    Mean change in Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.

  10. Effect of erenumab on depressive symptoms [ Time Frame: 12 weeks ]
    Mean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12

  11. Effect of erenumab on overall rosacea severity [ Time Frame: 12 weeks ]
    Mean change in overall rosacea severity from Baseline to week 4, 8 and 12. Evaluated by Rosacea Area and Severity Index (RASI)

  12. Effect of erenumab on rosacea symptoms [ Time Frame: 12 weeks ]
    Mean change in rosacea symptoms from Baseline to week 4, 8 and 12. Evaluated by Rosacea Clinical Scorecard (RCS)

  13. Effect of erenumab on rosacea-specific quality of life: Rosacea-specific Quality-of-Life index (RosaQoL) [ Time Frame: 12 weeks ]
    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)


Other Outcome Measures:
  1. Tolerability of erenumab in patients with rosacea [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between ages 18 - 65 years who have suffered from rosacea for at least 12 months.
  • If patient has concurrent migraine, a daily headache diary must be filled out

Criteria to be met prior to enrollment in the 4-week run-in period:

•Erythematotelangiectatic rosacea with a minimum of 15 days of either:

  • PSA > 2, and/or
  • Moderate, severe or extreme flushing measured by the Flushing Assessment Tool (FAST)

Exclusion Criteria:

  • Systemic treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
  • Topical treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
  • Cardiovascular disease of any kind, including cerebrovascular disease
  • Hypertension on the experimental day (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Hypotension on the experimental day (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
  • Ongoing psychiatric disease of any kind - unless it has been effectively treated with a stable treatment for at least 2 months.
  • Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient
  • Pregnant or breastfeeding women, or women expecting to conceive during the study
  • Women of childbearing potential who are unwilling to use an acceptable method of effective contraception during treatment through 16 weeks after the last dose of erenumab. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:

    • Age ≥ 55 years with cessation of menses for 12 or more months, OR
    • Age < 55 years but no spontaneous menses for at least 2 years, OR
    • Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g. spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved OR Underwent bilateral oophorectomy OR Underwent hysterectomy OR Underwent bilateral salpingectomy
  • Known sensitivity to any component of erenumab
  • Previously randomized into an erenumab study
  • Member of investigational site staff or relative of the investigator
  • Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419259


Contacts
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Contact: Nita KF Wienholtz, MD 0045-38634612 nita.wienholtz@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, Dk-2600
Contact: Nita Wienholtz, MD         
Principal Investigator: Messoud Ashina, MD, PhD, DMSc         
Sub-Investigator: Nita Wienholtz, MD         
Sub-Investigator: Thien Do, MD         
Sponsors and Collaborators
Messoud Ashina
Danish Headache Center
Novartis Pharmaceuticals
Herlev and Gentofte Hospital
Investigators
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Principal Investigator: Messoud Ashina, Professor Danish Headache Center
Study Director: Nita KF Wienholtz, MD Danish Headache Center
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Responsible Party: Messoud Ashina, Professor, MD, PhD, DMSc, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04419259    
Other Study ID Numbers: ROS031019
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rosacea
Flushing
Skin Diseases
Skin Manifestations
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs