A Phase 2 interventional study of AMG 334 in Rosacea, sponsored by Messoud Ashina. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Messoud Ashina · Phase 2, Interventional, and Treatment
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.
Criteria to be met prior to enrollment in the 4-week run-in period:
•Erythematotelangiectatic rosacea with a minimum of 15 days of either:
Exclusion Criteria:
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:
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)
Also known as: Erenumab
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)
Time frame: 12 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 12 weeks
Effect of erenumab on inflammatory lesions
Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Effect of erenumab on depressive symptoms
Mean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
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.
Time frame: 12 weeks
Plan to share: No
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