Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea

NCT ID: NCT04419259

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2021-08-31

Brief Summary

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.

Conditions

Rosacea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

AMG 334

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Erenumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Messoud Ashina

OTHER

Sponsor Role: lead

Responsible Party

Messoud Ashina

Professor, MD, PhD, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Messoud Ashina, Professor

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Nita KF Wienholtz, MD

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

Danish Headache Center

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nita KF Wienholtz, MD

Role: CONTACT

nita.wienholtz@regionh.dk

0045-38634612

Facility Contacts

Nita Wienholtz, MD

Role: primary

References

Wienholtz NKF, Christensen CE, Do TP, Frifelt LEW, Snellman J, Lopez-Lopez CL, Egeberg A, Thyssen JP, Ashina M. Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial. JAMA Dermatol. 2024 Jun 1;160(6):612-619. doi: 10.1001/jamadermatol.2024.0408.

Reference Type: DERIVED

PMID: 38630457 (View on PubMed)

Other Identifiers

ROS031019

Identifier Type: -

Identifier Source: org_study_id