Trial Outcomes & Findings for Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT) (NCT NCT03531957)
NCT ID: NCT03531957
Last Updated: 2023-07-03
Results Overview
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.
COMPLETED
PHASE2
244 participants
Week 12
2023-07-03
Participant Flow
First Patient Enrolled July 5, 2018 Last Patient Out August 14, 2019
Participant milestones
| Measure |
ASN002 40 mg
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
63
|
60
|
|
Overall Study
COMPLETED
|
51
|
54
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
14
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
Baseline characteristics by cohort
| Measure |
ASN002 40 mg
n=61 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=113 Participants
|
50 Participants
n=163 Participants
|
56 Participants
n=160 Participants
|
56 Participants
n=483 Participants
|
219 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Age, Continuous
|
40 years
n=113 Participants
|
36 years
n=163 Participants
|
39 years
n=160 Participants
|
42 years
n=483 Participants
|
40 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=113 Participants
|
28 Participants
n=163 Participants
|
32 Participants
n=160 Participants
|
31 Participants
n=483 Participants
|
125 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=113 Participants
|
31 Participants
n=163 Participants
|
31 Participants
n=160 Participants
|
29 Participants
n=483 Participants
|
118 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
13 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=113 Participants
|
46 Participants
n=163 Participants
|
46 Participants
n=160 Participants
|
47 Participants
n=483 Participants
|
190 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=113 Participants
|
6 participants
n=163 Participants
|
4 participants
n=160 Participants
|
5 participants
n=483 Participants
|
21 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=113 Participants
|
43 participants
n=163 Participants
|
51 participants
n=160 Participants
|
47 participants
n=483 Participants
|
188 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=113 Participants
|
10 participants
n=163 Participants
|
8 participants
n=160 Participants
|
8 participants
n=483 Participants
|
34 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: mITT
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.
Outcome measures
| Measure |
ASN002 40 mg
n=61 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12
|
-15.8 score on a scale
Standard Deviation 10.88
|
-15.8 score on a scale
Standard Deviation 9.82
|
-17.5 score on a scale
Standard Deviation 11.6
|
-13.1 score on a scale
Standard Deviation 11.87
|
SECONDARY outcome
Timeframe: Week 12Population: mITT (compared to PP all participants qualified for mITT were included but missing data were not imputed and not included in the percentages calculations)
Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12
Outcome measures
| Measure |
ASN002 40 mg
n=61 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)
|
49 percentage of patients
|
48.9 percentage of patients
|
48.8 percentage of patients
|
38.1 percentage of patients
|
SECONDARY outcome
Timeframe: Week 12Population: mITT (MMRM model was used)
The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).
Outcome measures
| Measure |
ASN002 40 mg
n=61 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in 5-D Pruritus (Itching) Scale
|
-6.6 change in score on a scale
Standard Deviation 5.29
|
-6.7 change in score on a scale
Standard Deviation 4.48
|
-6.3 change in score on a scale
Standard Deviation 5.14
|
-5.1 change in score on a scale
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Week 12Population: mITT (MMRM model was used to analyze the data)
In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease.
Outcome measures
| Measure |
ASN002 40 mg
n=61 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
|
-45.0 percentage change from baseline
Standard Deviation 33.81
|
-47.3 percentage change from baseline
Standard Deviation 28.41
|
-48.8 percentage change from baseline
Standard Deviation 28.02
|
-38.5 percentage change from baseline
Standard Deviation 31.66
|
SECONDARY outcome
Timeframe: Week 12Population: All patients with evaluable data at Week 12.
The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe.
Outcome measures
| Measure |
ASN002 40 mg
n=49 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=47 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=43 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=42 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1
|
26.5 percentage of patients
|
29.8 percentage of patients
|
23.3 percentage of patients
|
19.0 percentage of patients
|
SECONDARY outcome
Timeframe: Week 12Population: Change from baseline at Week 12
The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is.
Outcome measures
| Measure |
ASN002 40 mg
n=49 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=47 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=42 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=41 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
|
-8.9 score on a scale
Standard Deviation 8.37
|
-8.5 score on a scale
Standard Deviation 8.1
|
-9.1 score on a scale
Standard Deviation 7.91
|
-5.4 score on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: Week 12Population: All patients with available data at Week 12
Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is.
Outcome measures
| Measure |
ASN002 40 mg
n=49 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=47 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=43 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=41 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI)
|
-8.1 score on a scale
Standard Deviation 8.28
|
-5.9 score on a scale
Standard Deviation 6.59
|
-8.5 score on a scale
Standard Deviation 5.64
|
-5.5 score on a scale
Standard Deviation 6.48
|
SECONDARY outcome
Timeframe: Week 12Population: All patients with available data at Week 12
The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).
Outcome measures
| Measure |
ASN002 40 mg
n=49 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=47 Participants
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=43 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=42 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA)
|
-57.2 percentage change from baseline
Standard Deviation 36.22
|
-51.1 percentage change from baseline
Standard Deviation 51.6
|
-50.1 percentage change from baseline
Standard Deviation 53.57
|
-38.1 percentage change from baseline
Standard Deviation 47.65
|
Adverse Events
ASN002 40 mg
ASN002 60 mg
ASN002 80 mg
Placebo Oral Tablet
Serious adverse events
| Measure |
ASN002 40 mg
n=61 participants at risk
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 participants at risk
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 participants at risk
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 participants at risk
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.6%
1/61 • Number of events 1 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
0.00%
0/63 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
General disorders
pyrexia
|
1.6%
1/61 • Number of events 1 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
0.00%
0/63 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Nervous system disorders
dysarthria
|
1.6%
1/61 • Number of events 2 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
0.00%
0/63 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
1.6%
1/61 • Number of events 1 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
0.00%
0/63 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Nervous system disorders
seizure
|
0.00%
0/61 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
1.6%
1/63 • Number of events 1 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Infections and infestations
staphylococcal bacteremia
|
0.00%
0/61 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
1.6%
1/63 • Number of events 1 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
Other adverse events
| Measure |
ASN002 40 mg
n=61 participants at risk
40 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 60 mg
n=59 participants at risk
60 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
ASN002 80 mg
n=63 participants at risk
80 mg ASN002
ASN002: Daily dose of ASN002 for 12 weeks
|
Placebo Oral Tablet
n=60 participants at risk
Matching placebo for ASN002 doses
Placebo Oral Tablet: Placebo of ASN002 for 12 weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.6%
4/61 • Number of events 4 • 1 year, 1 month
|
13.6%
8/59 • Number of events 8 • 1 year, 1 month
|
6.3%
4/63 • Number of events 5 • 1 year, 1 month
|
8.3%
5/60 • Number of events 5 • 1 year, 1 month
|
|
Nervous system disorders
Headache
|
9.8%
6/61 • Number of events 6 • 1 year, 1 month
|
11.9%
7/59 • Number of events 7 • 1 year, 1 month
|
6.3%
4/63 • Number of events 4 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Gastrointestinal disorders
Nausea
|
8.2%
5/61 • Number of events 5 • 1 year, 1 month
|
6.8%
4/59 • Number of events 4 • 1 year, 1 month
|
7.9%
5/63 • Number of events 5 • 1 year, 1 month
|
3.3%
2/60 • Number of events 2 • 1 year, 1 month
|
|
Renal and urinary disorders
Urinary tract infection
|
6.6%
4/61 • Number of events 4 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
3.2%
2/63 • Number of events 2 • 1 year, 1 month
|
3.3%
2/60 • Number of events 2 • 1 year, 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/61 • Number of events 1 • 1 year, 1 month
|
0.00%
0/59 • 1 year, 1 month
|
9.5%
6/63 • Number of events 8 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61 • Number of events 1 • 1 year, 1 month
|
1.7%
1/59 • Number of events 1 • 1 year, 1 month
|
6.3%
4/63 • Number of events 5 • 1 year, 1 month
|
0.00%
0/60 • 1 year, 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place