Brepocitinib Overview & RVT-3101 Update
Phase 3 Atopic Dermatitis ADORING Program - Study Design
Two identically-designed pivotal trials followed by long-term, open-label extension
ADORING Study Design
Double-blind
Treatment
(8 weeks)
Tapinarof 1% QD
Long-term Open Label Extension
(48 weeks)
Patients with AD
➤ Ages 2 years & above
(max 20% 18 years)
➤IGA score ≥ 3
BSA ≥ 5% - 35%
EASI score > 6
(N=400 per pivotal study)
ADORING 1
(DMVT 3101)
R 2:1
ADORING 3
Vehicle QD
Tapinarof 1% QD
Long-term Extension (LTE)
(DMVT 3103)
Withdrawal & Re-treatment
ADORING 2
R 2:1
(DMVT 3102)
roivant
Vehicle QD
Primary endpoint:
› Proportion of subjects who have a vIGA-ADTM O or 1 Baseline at Week 8
Secondary endpoints:
› Proportion of subjects with EASI 75 @ week 8
› Mean change in %BSA from Baseline at Week 8
› Proportion of subjects with EASI 90 @ Week 8
› Proportion of subjects with > 4-pt reduction in PP-NRS @ Week 8
•
Follow-
Up
(7 Days)
Off-
Treatment
Enrollment Update
ADORING 1 & 2 enrollment
remains on track with data
expected 1H 2023
•
There is strong patient and
investigator enthusiasm for
the ADORING 3 long-term
extension study
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