A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

2 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Abrocitinib — DRUG
  Abrocitinib administered as liquid oral suspension.

Study Details

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Key Dates

Start date

Dec 2, 2025

Status verified

Apr 2026

Primary completion

Feb 22, 2032

Completion

Feb 22, 2032

Study Design

Enrollment

500 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Extension
  Patients who have completed other abrocitinib studies
• Experimental: De novo
  Patients who have not participated other abrocitinib studies

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation [ Time Frame: 0-24 months ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (7)

Find similar trials in Birmingham, AL

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