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
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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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →This is the only study on the registry with Messoud Ashina as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 who are unwilling to use an acceptable method of effective 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 by history, defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Mar 2021, 9 months after the start.
Of 20 phase 2 interventional studies under Rosacea, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erenumab