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

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: Unknown
• Conditions: Rosacea
• Intervention / Treatment: Drug: AMG 334

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nita KF Wienholtz, MD; Phone Number: 0045-38634612; Email: nita.wienholtz@regionh.dk

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Erenumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of erenumab on days of flushing	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

Outcome Measure	Measure Description	Time Frame
Effect of erenumab on erythema	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)	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	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	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	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	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	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	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	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	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	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	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)	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

Outcome Measure	Measure Description	Time Frame
Tolerability of erenumab in patients with rosacea	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

• Sponsor: Messoud Ashina
• Collaborators: Danish Headache Center; Novartis Pharmaceuticals; Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Messoud Ashina, Professor, Danish Headache Center; Study Director: Nita KF Wienholtz, MD, Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Flushing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID 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