CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry

Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alopecia Areata

Detailed Description

The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • CorEvitas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients are enrolled in the AA Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.

Description

Inclusion Criteria:

• A subject must meet all the following criteria to participate in the registry:

  1. Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
  2. Is at least 18 years of age or older.
  3. Is willing to provide Personal Information.
  4. Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.

Exclusion Criteria:

• Any of the following would exclude the subject from participating in the registry:

  1. Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:

Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Alopecia Areata; Pts presenting to enrolling sites across the US are invited to enroll if eligible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alopecia epidemiology, presentation, natural history, management, and outcomes	The major clinical outcomes include an assessment of the epidemiology of AA; to better understand the presentation, natural history, management and outcomes.	A minimum of 10 years from last patient enrolled

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician Reported - Skindex-16	every 6 months for 10 years
Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)	every 6 months for 10 years
Physician Reported - Dermatology Life Quality Index (DLQI)	every 6 months for 10 years
Physician Reported - Severity of Alopecia Tool (SALT)	every 6 months for 10 years
Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA)	every 6 months for 10 years
Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance	every 6 months for 10 years
Physician Reported - Alopecia Areata Scale (AAS)	every 6 months for 10 years
Patient Reported - Scalp Hair Assessment PRO	every 6 months for 10 years
Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance	every 6 months for 10 years
Patient Reported - Work Productivity and Activity Impairment (WPAI)	every 6 months for 10 years

Collaborators and Investigators

• Sponsor: CorEvitas

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: CorEvitas-AA-560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No