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.
Children aged 6 to <12 years at the time of informed consent/assent.
A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and
A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy.
Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.
Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.
Single group
Abrocitinib
DrugAbrocitinib 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.
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.
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
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.
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.
