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.
Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to \<12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Abrocitinib administered as liquid oral suspension.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation
The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.
Time frame: 0-24 months
Number of Participants With Clinically Significant Laboratory Abnormalities
The number of clinically significant laboratory abnormalities among participants with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a 2 -point reduction from baseline at all scheduled time points
Proportion of responders based on vIGA at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
Time frame: Baseline, 24 months
Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to <6 years
Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WI-NRS (in patients aged ≥2 to \<6 years) with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
Percentage of Response based on achieving a ≥4-point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged ≥6 to 12 years
Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WSI-NRS (in patients aged ≥6 to 12 years) with moderate-to-severe disease treated with abrocitinib.
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Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States
RECRUITINGArkansas Research Trials
North Little Rock, Arkansas, United States
RECRUITINGInvestigational Drug Service - Rady Childrens Hospital-San Diego
San Diego, California, United States
NOT_YET_RECRUITINGUniversity of California, San Diego/ Rady Children's Hospital - San Diego
San Diego, California, United States
NOT_YET_RECRUITINGSolutions Through Advanced Research
Jacksonville, Florida, United States
RECRUITINGAda West Research - Meridian
Meridian, Idaho, United States
NOT_YET_RECRUITINGDawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
RECRUITINGSaint Louis University
St Louis, Missouri, United States
RECRUITINGMedical University of South Carolina - South Carolina Translational Research Nexus Clinic
Charleston, South Carolina, United States
RECRUITINGTribe Clinical Research, LLC
Greenville, South Carolina, United States
RECRUITING...and 31 more locations
Time frame: 0-24 months
Percentage of Responders based on achieving Eczema Area and Severity Index (EASI)-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib
Percentage of response based on achieving ≥50%, ≥90%, 100% improvement from parent study baseline in the EASI total score (EASI-50, EASI-90, EASI-100) at all scheduled time points.
Time frame: 0-24 months
Percent Change from Baseline (CFB) in EASI total score at all scheduled time points.
Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
Time frame: 0-24 months
Percentage of Participants with Flares
Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points
Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points.
Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to \<16 years with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points
Mean CFB in IDQOL Index or CDQLI depending on age at all scheduled time points in participants aged \<4 years with moderate-to-severe disease treated with abrocitinib
Time frame: 0-24 months
CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points
Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in Dermatitis Family Impact (DFI) at all scheduled time points
Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points
Mean CFB in PGIS (in patients aged 6 to \<12 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points
Mean CFB in OGIS (in patients aged 2 to \<6 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
Time frame: 0-24 months
CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y)
Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo.
Time frame: 0-24 months
Number of topical corticosteroid and /or topical calcineurin inhibitor free days
Mean number of days free from topical corticosteroids and /or topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib.
Time frame: 0-24 months
Percentage of Participants Achieving satisfactory response in Tdap/DTaP and/or pneumococcal antibody titers as appropriate in participants who receive Tdap/DTaP and/or pneumococcal vaccinations
For patients that receive Tdap/ DTap and/or pneumococcal vaccinations during the study, the proportion of patients treated with abrocitinib who achieve satisfactory immunogenicity at 4 weeks after receiving the vaccinations.
Time frame: 0-24 months