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

June 9, 2020 updated by: Messoud Ashina

An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Glostrup, Denmark, Dk-2600
        • Recruiting
        • Danish Headache Center
        • Contact:
          • Nita Wienholtz, MD
        • Sub-Investigator:
          • Nita Wienholtz, MD
        • Sub-Investigator:
          • Thien Do, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Erenumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
12 weeks
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)
12 weeks
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)
12 weeks
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)
8 weeks
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).
12 weeks
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.
12 weeks
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
12 weeks
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.
12 weeks
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.
12 weeks
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
12 weeks
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 weeks
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)
12 weeks
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)
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Messoud Ashina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danish Headache Center
Novartis Pharmaceuticals
Herlev and Gentofte Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Messoud Ashina, Professor, Danish Headache Center
  • Study Director: Nita KF Wienholtz, MD, Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROS031019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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