| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06807281 | A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema | PHASE3 | RECRUITING | 500 | — | — | Dec 2, 2025 | Feb 22, 2032 | Apr 7, 2026 | 31 | United States, China +6 |
| NCT05375929 | A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India | PHASE3 | COMPLETED | 200 | — | — | Jul 16, 2022 | Mar 14, 2024 | Oct 15, 2024 | 15 | India |
| NCT04345367 | Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy | PHASE3 | COMPLETED | 727 | — | — | Jun 11, 2020 | Jul 13, 2021 | Jul 8, 2022 | 151 | United States, Australia +13 |
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.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.
The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
| Arm | Type | Description |
|---|---|---|
| Extension | EXPERIMENTAL | Patients who have completed other abrocitinib studies |
| De novo | EXPERIMENTAL | Patients who have not participated other abrocitinib studies |
| Abrocitinib 100 mg | EXPERIMENTAL | Participants will receive abrocitinib 100 mg by mouth (QD). |
| Abrocitinib 200 mg | EXPERIMENTAL | Participants will receive abrocitinib 200 mg QD. |
| Abrocitinib 200 mg plus placebo injection | EXPERIMENTAL | Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24 |
| Dupilumab 300 mg plus placebo tablets | ACTIVE_COMPARATOR | Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26 |
| Name | Type | Description |
|---|---|---|
| Abrocitinib | DRUG | Abrocitinib administered as liquid oral suspension. |
| Abrocitinib 100 mg | DRUG | Orally administered, abrocitinib 100 mg tablets QD |
| Abrocitinib 200 mg | DRUG | Orally administered, abrocitinib 200 mg tablets QD. |
| Dupilumab 300 mg | COMBINATION_PRODUCT | Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily. |
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 partic...