Trial Outcomes & Findings for Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (NCT NCT05117060)
NCT ID: NCT05117060
Last Updated: 2024-06-04
Results Overview
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
216 participants
Primary outcome timeframe
Week 0 to Week 16
Results posted on
2024-06-04
Participant Flow
This trial was conducted at 45 sites that screened subjects in 8 countries (Australia, Canada, Czech Republic (Czechia), Germany, Japan, Poland, Spain and the United States).
285 subjects were screened and 216 were randomized in a 4:3:3:4 ratio into the 4 treatment groups.
Participant milestones
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
45
|
49
|
61
|
|
Overall Study
COMPLETED
|
44
|
29
|
33
|
46
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
16
|
15
|
Reasons for withdrawal
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
5
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
5
|
6
|
|
Overall Study
Other
|
2
|
1
|
3
|
1
|
Baseline Characteristics
Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
n=61 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
n=45 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
n=49 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
n=61 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
204 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
35.0 years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
10 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
14 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 16Population: FAS, full analysis set.
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition.
Outcome measures
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
n=61 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
n=45 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
n=49 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
n=61 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Change in EASI From Baseline to Week 16
|
-9.99 score on a scale
Interval -12.85 to -7.13
|
-8.83 score on a scale
Interval -12.63 to -5.04
|
-8.87 score on a scale
Interval -12.47 to -5.28
|
-9.11 score on a scale
Interval -11.88 to -6.35
|
SECONDARY outcome
Timeframe: Week 0 to Week 16+3 daysPopulation: SAF, safety analysis set
Only treatment-emergent adverse events will be reported for this outcome measure. An adverse event will be considered treatment emergent if occurring after the first dose of treatment (Week 0) and up until 3 days after the last dose of treatment (Week 16+3 days for a participant completing the 16-week treatment period).
Outcome measures
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
n=44 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
n=31 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
n=33 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
n=38 Participants
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
|
109 events
|
67 events
|
80 events
|
75 events
|
Adverse Events
LEO 152020 - Dosing Regimen 1 (Higher Dose)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
LEO 152020 - Dosing Regimen 2 (Middle Dose)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
LEO 152020 - Dosing Regimen 3 (Lower Dose)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
LEO 152020 - Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
n=61 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
n=45 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
n=49 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
n=61 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/61 • Week 0 to Week 16+3 days
|
4.4%
2/45 • Number of events 2 • Week 0 to Week 16+3 days
|
0.00%
0/49 • Week 0 to Week 16+3 days
|
0.00%
0/61 • Week 0 to Week 16+3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/61 • Week 0 to Week 16+3 days
|
0.00%
0/45 • Week 0 to Week 16+3 days
|
2.0%
1/49 • Number of events 1 • Week 0 to Week 16+3 days
|
0.00%
0/61 • Week 0 to Week 16+3 days
|
Other adverse events
| Measure |
LEO 152020 - Dosing Regimen 1 (Higher Dose)
n=61 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 2 (Middle Dose)
n=45 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
|
LEO 152020 - Dosing Regimen 3 (Lower Dose)
n=49 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
|
LEO 152020 - Placebo
n=61 participants at risk
Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
4/61 • Number of events 5 • Week 0 to Week 16+3 days
|
2.2%
1/45 • Number of events 1 • Week 0 to Week 16+3 days
|
0.00%
0/49 • Week 0 to Week 16+3 days
|
0.00%
0/61 • Week 0 to Week 16+3 days
|
|
Gastrointestinal disorders
Nausea
|
13.1%
8/61 • Number of events 10 • Week 0 to Week 16+3 days
|
4.4%
2/45 • Number of events 2 • Week 0 to Week 16+3 days
|
10.2%
5/49 • Number of events 5 • Week 0 to Week 16+3 days
|
1.6%
1/61 • Number of events 1 • Week 0 to Week 16+3 days
|
|
Infections and infestations
COVID-19
|
9.8%
6/61 • Number of events 6 • Week 0 to Week 16+3 days
|
13.3%
6/45 • Number of events 6 • Week 0 to Week 16+3 days
|
4.1%
2/49 • Number of events 2 • Week 0 to Week 16+3 days
|
1.6%
1/61 • Number of events 1 • Week 0 to Week 16+3 days
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
6/61 • Number of events 6 • Week 0 to Week 16+3 days
|
8.9%
4/45 • Number of events 6 • Week 0 to Week 16+3 days
|
6.1%
3/49 • Number of events 3 • Week 0 to Week 16+3 days
|
4.9%
3/61 • Number of events 3 • Week 0 to Week 16+3 days
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
3/61 • Number of events 3 • Week 0 to Week 16+3 days
|
6.7%
3/45 • Number of events 3 • Week 0 to Week 16+3 days
|
4.1%
2/49 • Number of events 3 • Week 0 to Week 16+3 days
|
11.5%
7/61 • Number of events 7 • Week 0 to Week 16+3 days
|
|
Investigations
Electrocardiogram QT prolonged
|
1.6%
1/61 • Number of events 2 • Week 0 to Week 16+3 days
|
6.7%
3/45 • Number of events 3 • Week 0 to Week 16+3 days
|
12.2%
6/49 • Number of events 10 • Week 0 to Week 16+3 days
|
1.6%
1/61 • Number of events 1 • Week 0 to Week 16+3 days
|
|
Nervous system disorders
Headache
|
3.3%
2/61 • Number of events 2 • Week 0 to Week 16+3 days
|
8.9%
4/45 • Number of events 4 • Week 0 to Week 16+3 days
|
4.1%
2/49 • Number of events 2 • Week 0 to Week 16+3 days
|
1.6%
1/61 • Number of events 6 • Week 0 to Week 16+3 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
16.4%
10/61 • Number of events 14 • Week 0 to Week 16+3 days
|
24.4%
11/45 • Number of events 15 • Week 0 to Week 16+3 days
|
14.3%
7/49 • Number of events 8 • Week 0 to Week 16+3 days
|
21.3%
13/61 • Number of events 14 • Week 0 to Week 16+3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER