Trial design
ANZUPGO was evaluated in DELTA 1 & DELTA 2:
Two randomized, multicenter, double-blind, vehicle controlled, 16-week trials. Upon completion, patients were eligible to enter a single-arm, 36-week open-label extension, DELTA 3.1,3
RANDOMIZED, MULTICENTER, DOUBLE-BLIND,VEHICLE-CONTROLLED TRIALS
Primary endpoint1:
IGA-CHE treatment success (IGA-CHE 0/1 with at least a 2-point improvement from baseline) at Week 16
Select inclusion criteria4:
- CHE >3 months or relapsed ≥2x in a year, IGA-CHE score of 3 or 4, HESD-itch score of ≥4
- Inadequate response to TCS within 12 months or TCS medically inadvisable
Single-arm, open-label extension trial
Objective1:
To evaluate the long-term safety of ANZUPGO when used as needed
Select inclusion criteria5:
- Participants must have met the eligibility criteria at screening and baseline and have completed the treatment period in DELTA 1 and 2
BID=twice daily; HESD=Hand Eczema Symptom Diary; IGA-CHE=Investigator's Global Assessment of Chronic Hand Eczema; OLE=open-label extension.
†Patients were assessed at regular intervals and instructed to either use ANZUPGO BID (if IGA-CHE≥2) or pause until next assessment (if IGA-CHE=0/1).
Baseline Demographics1,3,4‡
Mean Age
44.1
Years
Che Severity
Severe
28%
Moderate
72%
Failed TCS3
99%
Gender
Female
64%
Male
36%
Symptoms§
Pain
6.7/10
Itch
7.1/10
Flares4
46%
Of patients had
6+ Flares
In the previous
Year
TCS=topical corticosteroids.
‡Pooled data from DELTA 1 and DELTA 2 trials.
§Evaluated using HESD, a self-reported 11-point rating scale designed to measure 6 CHE signs and symptoms over the past 24 hours.1
Primary Subtype Distribution1,7,8¶||
Atopic hand eczema
Hyperkeratotic
eczema
Irritant contact
dermatitis
Allergic contact
dermatitis
Vesicular hand
eczema
of all patients
were diagnosed with ≥2 overlapping CHE subtypes at the start of the studies1
¶Pooled data from DELTA 1 and DELTA 2 trials.
||Only one case of contact urticaria/protein contact dermatitis was reported in the cream vehicle group; none in the ANZUPGO group.1,9