Trial Outcomes & Findings for Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema (NCT NCT04378569)
NCT ID: NCT04378569
Last Updated: 2024-04-05
Results Overview
The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
230 participants
Primary outcome timeframe
Up to 3 weeks
Results posted on
2024-04-05
Participant Flow
This study was conducted at 36 centers in the United States, Canada, and Australia.
Participant milestones
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
65
|
61
|
32
|
33
|
32
|
|
Overall Study
COMPLETED
|
7
|
56
|
50
|
28
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
11
|
4
|
10
|
10
|
Reasons for withdrawal
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
7
|
4
|
5
|
4
|
|
Overall Study
Lack of response
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
All participants with baseline data available are included.
Baseline characteristics by cohort
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=65 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=61 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=32 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=33 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
n=32 Participants
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 9.18 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 15.08 • n=65 Participants
|
43.3 years
STANDARD_DEVIATION 15.05 • n=61 Participants
|
41.6 years
STANDARD_DEVIATION 15.33 • n=32 Participants
|
40.3 years
STANDARD_DEVIATION 12.06 • n=33 Participants
|
43.3 years
STANDARD_DEVIATION 13.36 • n=32 Participants
|
42.2 years
STANDARD_DEVIATION 14.24 • n=230 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=7 Participants
|
37 Participants
n=65 Participants
|
39 Participants
n=61 Participants
|
21 Participants
n=32 Participants
|
15 Participants
n=33 Participants
|
23 Participants
n=32 Participants
|
140 Participants
n=230 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=7 Participants
|
28 Participants
n=65 Participants
|
22 Participants
n=61 Participants
|
11 Participants
n=32 Participants
|
18 Participants
n=33 Participants
|
9 Participants
n=32 Participants
|
90 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=7 Participants
|
11 Participants
n=65 Participants
|
12 Participants
n=61 Participants
|
5 Participants
n=32 Participants
|
8 Participants
n=33 Participants
|
5 Participants
n=32 Participants
|
44 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=7 Participants
|
54 Participants
n=65 Participants
|
49 Participants
n=61 Participants
|
27 Participants
n=32 Participants
|
25 Participants
n=33 Participants
|
27 Participants
n=32 Participants
|
186 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
4 Participants
n=65 Participants
|
2 Participants
n=61 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
3 Participants
n=32 Participants
|
15 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=61 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=7 Participants
|
9 Participants
n=65 Participants
|
8 Participants
n=61 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
4 Participants
n=32 Participants
|
28 Participants
n=230 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=7 Participants
|
51 Participants
n=65 Participants
|
48 Participants
n=61 Participants
|
23 Participants
n=32 Participants
|
27 Participants
n=33 Participants
|
25 Participants
n=32 Participants
|
180 Participants
n=230 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
2 Participants
n=61 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=61 Participants
|
2 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=230 Participants
|
|
Investigator Global Assessment (IGA) Categorical Scores at Baseline
0 - Clear
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=230 Participants
|
|
Investigator Global Assessment (IGA) Categorical Scores at Baseline
1 - Almost Clear
|
0 Participants
n=7 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=230 Participants
|
|
Investigator Global Assessment (IGA) Categorical Scores at Baseline
2 - Mild
|
1 Participants
n=7 Participants
|
12 Participants
n=65 Participants
|
8 Participants
n=61 Participants
|
8 Participants
n=32 Participants
|
7 Participants
n=33 Participants
|
9 Participants
n=32 Participants
|
45 Participants
n=230 Participants
|
|
Investigator Global Assessment (IGA) Categorical Scores at Baseline
3 - Moderate
|
5 Participants
n=7 Participants
|
45 Participants
n=65 Participants
|
44 Participants
n=61 Participants
|
21 Participants
n=32 Participants
|
21 Participants
n=33 Participants
|
21 Participants
n=32 Participants
|
157 Participants
n=230 Participants
|
|
Investigator Global Assessment (IGA) Categorical Scores at Baseline
4 - Severe
|
1 Participants
n=7 Participants
|
8 Participants
n=65 Participants
|
9 Participants
n=61 Participants
|
3 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=32 Participants
|
28 Participants
n=230 Participants
|
|
IGA Mean Scores at Baseline
|
3.0 score on a scale
STANDARD_DEVIATION 0.58 • n=7 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 0.56 • n=65 Participants
|
3.0 score on a scale
STANDARD_DEVIATION 0.53 • n=61 Participants
|
2.8 score on a scale
STANDARD_DEVIATION 0.57 • n=32 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 0.61 • n=33 Participants
|
2.8 score on a scale
STANDARD_DEVIATION 0.55 • n=32 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 0.56 • n=230 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
|
6.7 score on a scale
STANDARD_DEVIATION 2.56 • n=7 Participants • All participants with baseline data available are included.
|
5.8 score on a scale
STANDARD_DEVIATION 2.45 • n=64 Participants • All participants with baseline data available are included.
|
5.8 score on a scale
STANDARD_DEVIATION 2.75 • n=60 Participants • All participants with baseline data available are included.
|
6.0 score on a scale
STANDARD_DEVIATION 3.19 • n=32 Participants • All participants with baseline data available are included.
|
5.5 score on a scale
STANDARD_DEVIATION 2.83 • n=33 Participants • All participants with baseline data available are included.
|
5.0 score on a scale
STANDARD_DEVIATION 2.80 • n=31 Participants • All participants with baseline data available are included.
|
5.7 score on a scale
STANDARD_DEVIATION 2.74 • n=227 Participants • All participants with baseline data available are included.
|
|
Hand Eczema Severity Index (HECSI) Mean Baseline Score
|
57.4 score on a scale
STANDARD_DEVIATION 58.35 • n=7 Participants
|
43.7 score on a scale
STANDARD_DEVIATION 31.43 • n=65 Participants
|
43.9 score on a scale
STANDARD_DEVIATION 35.74 • n=61 Participants
|
37.1 score on a scale
STANDARD_DEVIATION 34.51 • n=32 Participants
|
45.8 score on a scale
STANDARD_DEVIATION 50.31 • n=33 Participants
|
38.9 score on a scale
STANDARD_DEVIATION 32.72 • n=32 Participants
|
42.9 score on a scale
STANDARD_DEVIATION 37.08 • n=230 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All treated participants in Cohort 1 are included.
The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All treated participants in Cohort 1 are included.
The number of Cohort 1 participants with AEs coded as application site events is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With an Application Site Reaction
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All treated participants in Cohort 1 are included.
The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All treated participants in Cohort 1 are included.
The number of Cohort 1 participants with a significant change in hematology is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All treated participants in Cohort 1 are included.
The number of Cohort 1 participants with a significant change in chemistry is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=59 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=50 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=28 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=46 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
|
0 Participants
|
23 Participants
|
15 Participants
|
10 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus ≥2-point improvement (ie, decrease) from Baseline is presented.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=58 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=31 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=64 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Week 2
|
0 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Week 4
|
0 Participants
|
14 Participants
|
11 Participants
|
2 Participants
|
13 Participants
|
—
|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Week 8
|
0 Participants
|
12 Participants
|
15 Participants
|
4 Participants
|
14 Participants
|
—
|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Week 12
|
0 Participants
|
20 Participants
|
13 Participants
|
5 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline in IGA score is presented.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=58 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=31 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=64 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Week 2
|
—
|
9 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
—
|
|
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Week 4
|
—
|
15 Participants
|
14 Participants
|
2 Participants
|
13 Participants
|
—
|
|
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Week 8
|
—
|
13 Participants
|
17 Participants
|
4 Participants
|
14 Participants
|
—
|
|
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Week 12
|
—
|
22 Participants
|
16 Participants
|
5 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline is presented.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=58 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=31 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=64 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Week 4
|
—
|
15 Participants
|
13 Participants
|
4 Participants
|
15 Participants
|
—
|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Week 2
|
—
|
9 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
—
|
|
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Week 8
|
—
|
15 Participants
|
16 Participants
|
6 Participants
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All participants in Cohort 2 are included.
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=65 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=61 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=32 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=65 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Week 8
|
—
|
-0.73 units on a scale
Standard Deviation 0.149
|
-0.84 units on a scale
Standard Deviation 0.153
|
-0.57 units on a scale
Standard Deviation 0.203
|
-0.78 units on a scale
Standard Deviation 0.150
|
—
|
|
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Week 2
|
—
|
-0.55 units on a scale
Standard Deviation 0.107
|
-0.50 units on a scale
Standard Deviation 0.109
|
-0.35 units on a scale
Standard Deviation 0.143
|
-0.48 units on a scale
Standard Deviation 0.105
|
—
|
|
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Week 4
|
—
|
-0.68 units on a scale
Standard Deviation 0.126
|
-0.71 units on a scale
Standard Deviation 0.129
|
-0.58 units on a scale
Standard Deviation 0.174
|
-0.72 units on a scale
Standard Deviation 0.129
|
—
|
|
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Week 12
|
—
|
-1.04 units on a scale
Standard Deviation 0.149
|
-0.93 units on a scale
Standard Deviation 0.155
|
-0.73 units on a scale
Standard Deviation 0.205
|
-0.80 units on a scale
Standard Deviation 0.150
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All participants in Cohort 2 with data available are included.
The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean change from baseline in WI-NRS is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=61 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=59 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=32 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=59 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 4
|
—
|
-3.00 score on a scale
Standard Error 0.359
|
-2.48 score on a scale
Standard Error 0.372
|
-3.75 score on a scale
Standard Error 0.504
|
-2.49 score on a scale
Standard Error 0.373
|
—
|
|
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 2
|
—
|
-2.43 score on a scale
Standard Error 0.365
|
-2.25 score on a scale
Standard Error 0.360
|
-3.16 score on a scale
Standard Error 0.469
|
-1.80 score on a scale
Standard Error 0.355
|
—
|
|
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 8
|
—
|
-3.39 score on a scale
Standard Error 0.338
|
-2.85 score on a scale
Standard Error 0.361
|
-3.48 score on a scale
Standard Error 0.476
|
-2.64 score on a scale
Standard Error 0.362
|
—
|
|
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 12
|
—
|
-3.71 score on a scale
Standard Error 0.323
|
-3.39 score on a scale
Standard Error 0.349
|
-3.87 score on a scale
Standard Error 0.444
|
-3.08 score on a scale
Standard Error 0.354
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All randomized participants in Cohort 2 with data available and who had baseline WI-NRS scores ≥4 are included.
The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of ≥4 who achieved a ≥4-point reduction is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=48 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=47 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=24 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=42 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Week 2
|
—
|
21 Participants
|
20 Participants
|
14 Participants
|
12 Participants
|
—
|
|
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Week 4
|
—
|
23 Participants
|
19 Participants
|
15 Participants
|
14 Participants
|
—
|
|
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Week 8
|
—
|
29 Participants
|
20 Participants
|
15 Participants
|
15 Participants
|
—
|
|
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Week 12
|
—
|
30 Participants
|
21 Participants
|
16 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All participants in Cohort 2 with data available are included.
The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers \[except tips\], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=58 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=31 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=64 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Week 2
|
—
|
-18.3 score on a scale
Standard Deviation 27.39
|
-13.6 score on a scale
Standard Deviation 21.67
|
-4.0 score on a scale
Standard Deviation 22.37
|
-12.4 score on a scale
Standard Deviation 31.84
|
—
|
|
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Week 4
|
—
|
-21.3 score on a scale
Standard Deviation 28.38
|
-21.0 score on a scale
Standard Deviation 24.78
|
-8.8 score on a scale
Standard Deviation 20.22
|
-14.6 score on a scale
Standard Deviation 30.89
|
—
|
|
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Week 8
|
—
|
-22.7 score on a scale
Standard Deviation 29.50
|
-19.7 score on a scale
Standard Deviation 27.12
|
-8.3 score on a scale
Standard Deviation 25.16
|
-17.8 score on a scale
Standard Deviation 33.15
|
—
|
|
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Week 12
|
—
|
-25.8 score on a scale
Standard Deviation 30.25
|
-26.3 score on a scale
Standard Deviation 29.85
|
-14.5 score on a scale
Standard Deviation 19.19
|
-18.6 score on a scale
Standard Deviation 36.12
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All participants in Cohort 2 with data available are included.
The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=59 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=32 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=58 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Week 2
|
—
|
-1.75 score on a scale
Standard Deviation 2.368
|
-1.74 score on a scale
Standard Deviation 2.464
|
-1.86 score on a scale
Standard Deviation 2.923
|
-0.71 score on a scale
Standard Deviation 2.298
|
—
|
|
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Week 4
|
—
|
-2.18 score on a scale
Standard Deviation 2.611
|
-1.66 score on a scale
Standard Deviation 2.704
|
-2.34 score on a scale
Standard Deviation 2.897
|
-0.88 score on a scale
Standard Deviation 2.176
|
—
|
|
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Week 8
|
—
|
-2.15 score on a scale
Standard Deviation 2.722
|
-1.64 score on a scale
Standard Deviation 3.062
|
-2.29 score on a scale
Standard Deviation 3.224
|
-0.89 score on a scale
Standard Deviation 2.205
|
—
|
|
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Week 12
|
—
|
-2.58 score on a scale
Standard Deviation 2.700
|
-1.95 score on a scale
Standard Deviation 2.708
|
-2.11 score on a scale
Standard Deviation 3.439
|
-1.06 score on a scale
Standard Deviation 2.602
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: All participants in Cohort 2 who had baseline NRS Pain scores ≥4 and with data available are included.
The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with ≥4-point reduction from baseline NRS Pain score is reported.
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=30 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=25 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=17 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=20 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Week 2
|
—
|
15 Participants
|
8 Participants
|
8 Participants
|
3 Participants
|
—
|
|
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Week 4
|
—
|
17 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
—
|
|
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Week 8
|
—
|
17 Participants
|
10 Participants
|
9 Participants
|
4 Participants
|
—
|
|
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Week 12
|
—
|
20 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 13Population: All participants in Cohort 2 with data available are included.
The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema').
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=62 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=59 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=30 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=63 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Week 2
|
—
|
-13.7 score on a scale
Standard Error 1.89
|
-15.1 score on a scale
Standard Error 1.92
|
-11.0 score on a scale
Standard Error 2.64
|
-9.3 score on a scale
Standard Error 1.86
|
—
|
|
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Week 4
|
—
|
-17.4 score on a scale
Standard Error 2.44
|
-18.5 score on a scale
Standard Error 2.49
|
-15.3 score on a scale
Standard Error 3.45
|
-13.4 score on a scale
Standard Error 2.56
|
—
|
|
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Week 8
|
—
|
-16.6 score on a scale
Standard Error 2.59
|
-19.6 score on a scale
Standard Error 2.61
|
-20.8 score on a scale
Standard Error 3.65
|
-12.0 score on a scale
Standard Error 2.67
|
—
|
|
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Week 12
|
—
|
-19.2 score on a scale
Standard Error 2.77
|
-24.9 score on a scale
Standard Error 2.95
|
-22.3 score on a scale
Standard Error 3.89
|
-15.3 score on a scale
Standard Error 3.04
|
—
|
|
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Week 13
|
—
|
-20.9 score on a scale
Standard Error 2.76
|
-22.9 score on a scale
Standard Error 2.89
|
-18.9 score on a scale
Standard Error 3.81
|
-15.6 score on a scale
Standard Error 3.04
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12Population: All participants in Cohort 2 with data available are included.
The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions).
Outcome measures
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=61 Participants
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=52 Participants
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=31 Participants
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=63 Participants
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Week 2
|
—
|
-0.185 Percentage of Total BSA
Standard Error 0.0517
|
-0.132 Percentage of Total BSA
Standard Error 0.0559
|
-0.028 Percentage of Total BSA
Standard Error 0.0697
|
-0.119 Percentage of Total BSA
Standard Error 0.0509
|
—
|
|
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Week 4
|
—
|
-0.310 Percentage of Total BSA
Standard Error 0.0583
|
-0.319 Percentage of Total BSA
Standard Error 0.0634
|
-0.151 Percentage of Total BSA
Standard Error 0.0818
|
-0.139 Percentage of Total BSA
Standard Error 0.0616
|
—
|
|
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Week 8
|
—
|
-0.319 Percentage of Total BSA
Standard Error 0.0746
|
-0.273 Percentage of Total BSA
Standard Error 0.0808
|
-0.241 Percentage of Total BSA
Standard Error 0.1039
|
-0.223 Percentage of Total BSA
Standard Error 0.0744
|
—
|
|
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Week 12
|
—
|
-0.429 Percentage of Total BSA
Standard Error 0.0681
|
-0.409 Percentage of Total BSA
Standard Error 0.0759
|
-0.296 Percentage of Total BSA
Standard Error 0.0948
|
-0.307 Percentage of Total BSA
Standard Error 0.0751
|
—
|
Adverse Events
Cohort 1: ARQ-252 Cream 0.3% QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: ARQ-252 Cream 0.3% QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: ARQ-252 Cream 0.3% BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: ARQ-252 Cream 0.1% QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Vehicle Cream QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: Vehicle Cream BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: ARQ-252 Cream 0.3% QD
n=7 participants at risk
Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% QD
n=65 participants at risk
Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.3% BID
n=61 participants at risk
Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.
|
Cohort 2: ARQ-252 Cream 0.1% QD
n=32 participants at risk
Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream QD
n=33 participants at risk
Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.
|
Cohort 2: Vehicle Cream BID
n=32 participants at risk
Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Up to ~14 weeks
All treated participants are included.
|
3.1%
2/65 • Up to ~14 weeks
All treated participants are included.
|
3.3%
2/61 • Up to ~14 weeks
All treated participants are included.
|
6.2%
2/32 • Up to ~14 weeks
All treated participants are included.
|
0.00%
0/33 • Up to ~14 weeks
All treated participants are included.
|
3.1%
1/32 • Up to ~14 weeks
All treated participants are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Up to ~14 weeks
All treated participants are included.
|
0.00%
0/65 • Up to ~14 weeks
All treated participants are included.
|
0.00%
0/61 • Up to ~14 weeks
All treated participants are included.
|
3.1%
1/32 • Up to ~14 weeks
All treated participants are included.
|
6.1%
2/33 • Up to ~14 weeks
All treated participants are included.
|
0.00%
0/32 • Up to ~14 weeks
All treated participants are included.
|
Additional Information
Arcutis Medical Information
Arcutis Biotherapeutics
Phone: +1 (844) 692-6729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER