Rosacea MedDRA version: 20.0 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Aimovig (Erenumab)
Pharmaceutical Form: Injection
INN or Proposed INN: ERENUMAB
CAS Number: 1582205-90
Other descriptive name: Aimovig
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Rigshospitalet Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Erythematotelangiectatic rosacea with a minimum of 15 days in the run-in period of either: oPSA > 2 for a minimum 15 days, and/or oModerate, severe or extreme flushing for a minimum of 15 days measured by the Flushing Assessment Tool (PSA) •Men and women aged 18 – 65 years •Minimum 12 months of rosacea prior to trial •If patient has concurrent migraine, a daily headache diary must be filled out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II[1]) from Baseline to week 12.;Secondary Objective: 1.Mean change in Clinician’s Erythema Assessment 2.Mean change in Dermatology Life Quality Index 3.Proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing 4.Mean change in number of days with moderate, severe or extreme flushing 5.Mean change in Hospital Anxiety and Depression Scale 6.Proportion of patients with Investigator’s Global Assessment ‘0’ or ‘1’ with an at least 2-point reduction 7.Mean change in Inflammatory Lesion Count 8.Proportion of patients with at least 50% reduction in number of days with Patient’s Self-Assessment (PSA) >2 9.Mean change PSA 10.Mean change in Quick Inventory Depressive Symptomatology 11.Mean change in Rosacea Area and Severity Index 12.Mean change in Rosacea Clinical Scorecard 13.Mean change in Rosacea-specific Quality-of-Life index;Primary end point(s): Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II);Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Mean change in Clinician’s Erythema Assessment (CEA) from baseline to week 4, 8 and 12. 2.Mean change in Dermatology Life Quality Index (DLQI) from baseline to week 4, 8 and 12. 3.Proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II) from baseline to week 4, 8 and 12. 4.Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II) from baseline to week 4 and 8. 5.Mean change in Hospital Anxiety and Depression Scale (HADS) from baseline to week 4, 8 and 12. 6.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.Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12. 8.Proportion of patients with at least 50% reduction in number of days with Patient’s Self-Assessment (PSA) >2 from baseline to week 4, 8 and 12. 9.Mean change Patient’s Self-Assessment (PSA) from baseline to week 4, 8 and 12. 10.Mean change in Quick Inventory Depressive Symptomatology (QIDS) from baseline to week 4, 8 and 12. 11.Mean change in Rosacea Area and Severity Index (RASI) from baseline to week 4, 8 and 12. 12.Mean change in Rosacea Clinical Scorecard (RCS) from baseline to week 4, 8 and 12. 13.Mean change in Rosacea-specific Quality-of-Life index (RosaQoL) from baseline to week 4, 8 and 12.;Timepoint(s) of evaluation of this end point: 4, 8 and 12 weeks | — |
Countries
Denmark
Contacts
Public ContactNita Wienholtz
Danish Headache Center
Outcome results
None listed