CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Recruiting

• Conditions: Alopecia Areata

• Registration Number: NCT06562270
• Lead Sponsor: CorEvitas

Brief Summary

Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areata,receiving routine care from dermatology providers. Visit schedules for patients will be determined by the provider in accordance with routine clinical care, and any prescriptions provided to patients will adhere to product availability and local prescribing guidelines/regulations in the country where the participating registry site is located.

Detailed Description

The objective of the registry is to create a cohort of adolescent subjects to evaluate the long-term real-world safety and effectiveness of routine clinical care of treatments for severe AA. Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers.

This will be enabled through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.

Study Timeline

• Study Start: 2024-03-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2099-12-31
• Study Completion: 2099-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

To be eligible to participate in this registry, an individual must meet all the following criteria:

1. Has ever been diagnosed with severe AA by a dermatologist or a qualified dermatology provider.
2. Is 12-17 years of age at the time of enrollment.
3. Is willing to provide consent/assent for participation in the registry.
4. Has been prescribed a new commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents in the context of routine clinical care that is consistent with local prescribing guidelines and/or regulations for the country where the site is located.

A new therapy is a medication that the subject has never taken before.

1. At the time of registry enrollment OR
2. Within 6 months prior to registry enrollment In the opinion of the treating provider, is deemed a candidate for treatment with a commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents but has not received nor is planning to initiate treatment at the time of registry enrollment.

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Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in the registry:

1. Is participating or planning to participate in a blinded clinical trial for any investigational medication.
2. Is unwilling or unable to provide standing height measurements.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AA epidemiology, presentation, natural history, management, and outcomes	Through Study completion until the subject is 18 years	The major clinical outcomes include an assessment of the epidemiology of Alopecia Areata; to better understand the presentation, natural history, management and outcomes.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with history of comorbidities	at registry enrollment	Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs
Patient reported : Hair Concealment Question	every 6 months until the subject is 18 years	Helps to determine alopecia
Patient reported : Stressful Life Event	every 6 months until the subject is 18 years	Determines correlation between the disease \& stressful life events
Patient reported : Scalp Hair Assessment	every 6 months until the subject is 18 years	Determines hair loss
Patient reported :Measures for Eye Irritation & Nail Appearance	every 6 months until the subject is 18 years	Determines eye irritation \& nail appearance due to alopecia
Patient reported : Numerical Rating Scale for Nasal irritation	every 6 months until the subject is 18 years	Determines nasal irritation due to alopecia
Patient reported : Patient Health Questionnaire (PHQ)	every 6 months until the subject is 18 years	Determines depression in subjects with alopecia
Patient reported :PROMIS Pediatric Sleep Disturbance 4 a	every 6 months until the subject is 18 years	Determines sleep disturbance in subjects with alopecia
Patient reported : PROMIS Pediatric Stigma 8a	every 6 months until the subject is 18 years	Determines Stigma in subjects with alopecia
Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO)	every 6 months until the subject is 18 years	To assess the consequences associated with Alopecia Areata (AA) of the highest priority to the patients, including hair loss signs, emotional symptoms, and activity limitations
Patient reported : Grief Assessment	every 6 months until the subject is 18 years	Determines level of grief in subjects with alopecia
Patient reported : Pubertal Tanner Staging	every 6 months until the subject is 18 years	Determines pubertal progression
Physician reported : Pubertal Progression: Tanner Staging Assessment	Every six Months until a subject is 18 years or the subjects reaches stage 5 of the tanner stangings assessment	Determines pubertal progression
Physician reported : Severity of Alopecia Tool (SALT)	every 6 months until the subject is 18 years	Determines percentage for hair loss \& ranges from 0 to 100
Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA)	every 6 months until the subject is 18 years	Helps in clinical evaluation of Alopecia Aareata
Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance	every 6 months until the subject is 18 years	Determines hair loss in patients with alopecia aareata

Trial Locations

Locations (1)

CorEvitas, LLC; 🇺🇸 Waltham, Massachusetts, United States