Abrocitnib compared with Dupilumab in adults with Atopic Dermatitis
Research type
Research Study
Full title
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
IRAS ID
281192
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2019-004013-13
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
Research Summary
The purpose of this study is to compare the effects of the study drugs (abrocitinib, also known as PF-04965842, and dupilumab) to find out which is better for treating AD in adults who are also receiving medicated and non-medicated skin therapy.
Abrocitinib is in tablet form and Dupilumab is an injectable. The participant will receive either Abrocitinib along with a placebo (which is an injectable to look like Dupilumab) or Dupilumab along with a placebo (which is in tablet form to look like Abrocitinib).This phase 3 the researchers will compare the results of taking abrocitinib to the results of taking dupilumab to see if there are any differences. This is randomised and double blinded which means participant or the study doctor will not know what drug they are assigned to.
The participant will be in this study for about 34 weeks (about 8 months). They will need to visit the study site about 10 times during the study and will have 2 phone calls from the study team.
There will be approximately 600 people in this study. The study is being done at about 220 different study sites in about 22 countries. This study is available to adults over the age of 18.Summary of Results
Study Design This was a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg QD (once daily) administered orally compared with dupilumab 300 mg or its matching placebo administered by subcutaneous injection Q2W (every 2 weeks), with a loading dose of 600 mg at baseline as per label guidelines, concomitantly with topical therapy in adult participants with moderate to severe atopic dermatitis (AD). This study provided data that estimated the relative efficacy of abrocitinib and dupilumab. The treatment duration was 26 weeks, with the last dose of dupilumab occurring at Week 24. There were primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints were assessed throughout the entire study.
Efficacy Results
The results of the primary endpoints, Peak Pruritus Numerical Rating Scale (PP-NRS4) at Week 2 and EASI total score (EASI-90) at Week 4, demonstrated that abrocitinib 200 mg QD is superior to dupilumab 300 mg Q2W as a therapy for AD. The key secondary endpoint result, EASI-90 at Week 16, demonstrated that abrocitinib 200 mg QD is not inferior, and is superior, to dupilumab 300 mg Q2W as a therapy for AD.
All of the secondary endpoint results and most of the patient reported outcomes (PRO) endpoint results measured in this study demonstrated that abrocitinib 200 mg QD showed improved efficacy as a therapy for AD, compared with dupilumab 300 mg Q2W.Safety Results
This study, in accordance with past clinical studies with abrocitinib and dupilumab, demonstrated that abrocitinib administered 200 mg QD had an acceptable safety profile as compared with dupilumab 300 mg Q2W and was well-tolerated as a therapy for AD. No new or unexpected safety findings were observed in either treatment group.
Two deaths were reported, 1 resulting from a COVID-19 infection, the other from cardio-respiratory arrest and intracranial hemorrhage. Both events occurred in participants in the abrocitinib 200 mg QD treatment group; neither were considered treatment-related by investigator or sponsor.
Most adverse events (AEs) were mild to moderate in severity. The proportion of participants with AEs was greater in the abrocitinib treatment group compared with the dupilumab treatment group. The proportion of participants with serious adverse Events (SAEs) was similar in both treatment groups.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0149
Date of REC Opinion
26 Aug 2020
REC opinion
Further Information Favourable Opinion