Atopic Dermatitis
Conditions
Keywords
eczema, atopic dermatitis
Brief summary
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.
Detailed description
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.
Interventions
DRUGAbrocitinib
Abrocitinib administered as liquid oral suspension.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
for the Extension Cohort: 1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old). • No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention. Inclusion Criteria for the De Novo Cohort: Age 1. Children aged 6 to \<12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Disease Characteristics: 2. Participants who meet all of the following AD criteria: * 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. Other Inclusion Criteria: 3. Body weight ≥15 kg
Exclusion criteria
for the Extension Cohort: Medical Conditions: 1. 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. If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents. Prior/Concomitant Therapy: 2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol. 3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment. Diagnostic Assessments: 4. 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. 5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation | 0-24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Abnormalities | 0-24 months | 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 | Baseline, 24 months | 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 | 0-24 months | 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 | 0-24 months | 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. |
| 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 | 0-24 months | 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. |
| Percent Change from Baseline (CFB) in EASI total score at all scheduled time points. | 0-24 months | Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib |
| Percentage of Participants with Flares | 0-24 months | Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib. |
| CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points | 0-24 months | Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib. |
| CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points. | 0-24 months | Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to \<16 years with moderate-to-severe disease treated with abrocitinib. |
| CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points | 0-24 months | 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 |
| CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points | 0-24 months | Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib. |
| CFB in Dermatitis Family Impact (DFI) at all scheduled time points | 0-24 months | Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib. |
| CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points | 0-24 months | 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. |
| CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points | 0-24 months | 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 |
| CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y) | 0-24 months | Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo. |
| Number of topical corticosteroid and /or topical calcineurin inhibitor free days | 0-24 months | Mean number of days free from topical corticosteroids and /or topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib. |
| 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 | 0-24 months | 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. |
Countries
China, Germany, Hungary, Japan, Mexico, Poland, Spain, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed