Trial Outcomes & Findings for A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD (NCT NCT05470114)
NCT ID: NCT05470114
Last Updated: 2025-03-11
Results Overview
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From baseline to week 4
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
LEO 138559
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
LEO 138559
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
Baseline characteristics by cohort
| Measure |
LEO 138559
n=9 Participants
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
n=4 Participants
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
30.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Baseline height (cm)
|
176.1 cm
STANDARD_DEVIATION 11.1 • n=5 Participants
|
171.0 cm
STANDARD_DEVIATION 4.7 • n=7 Participants
|
174.5 cm
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Baseline weight (kg)
|
82.49 kg
STANDARD_DEVIATION 13.61 • n=5 Participants
|
71.75 kg
STANDARD_DEVIATION 9.98 • n=7 Participants
|
79.18 kg
STANDARD_DEVIATION 13.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 4Population: The analysis population consists of individuals with AD, and the gene expression analysis is based on lesional skin biopsies obtained from these individuals at baseline and week 4. The gene expression values used in the analysis are averaged expression values for each identity class. These values were calculated using the AverageExpression function on the basis of normalized data from the respective Seurat object. In LEO 138559 Arm group, 1 participant screened but not included in the analysis.
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
Outcome measures
| Measure |
LEO 138559
n=8 Participants
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
n=4 Participants
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
|---|---|---|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes S100A7
|
0.212 fold change
Standard Deviation 7.692
|
0.043 fold change
Standard Deviation 8.899
|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes S100A8
|
0.155 fold change
Standard Deviation 6.308
|
0.048 fold change
Standard Deviation 5.367
|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes S100A9
|
0.149 fold change
Standard Deviation 5.52
|
0.02 fold change
Standard Deviation 13.99
|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes KRT6A
|
0.164 fold change
Standard Deviation 4.08
|
0.088 fold change
Standard Deviation 1.459
|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes KRT16
|
0.246 fold change
Standard Deviation 2.75
|
0.094 fold change
Standard Deviation 1.731
|
|
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Keratinocytes KRT1
|
1.355 fold change
Standard Deviation 1.748
|
0.851 fold change
Standard Deviation 5.008
|
SECONDARY outcome
Timeframe: Between baseline and week 16Outcome measures
| Measure |
LEO 138559
n=9 Participants
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
n=4 Participants
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
|---|---|---|
|
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
|
17 Events
|
8 Events
|
Adverse Events
LEO 138559
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Dupixent®
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 138559
n=9 participants at risk
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by subcutaneous injection.
|
Dupixent®
n=4 participants at risk
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®: Dupixent® is an antibody given by subcutaneous injection.
|
|---|---|---|
|
Eye disorders
Eye irritation
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/9 • Baseline to 16 week
|
25.0%
1/4 • Number of events 1 • Baseline to 16 week
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
General disorders
Injection site erythema
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
General disorders
Injection site swelling
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/9 • Baseline to 16 week
|
25.0%
1/4 • Number of events 1 • Baseline to 16 week
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Infections and infestations
Malassezia infection
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Infections and infestations
Staphylococcal skin infection
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Infections and infestations
Tinea pedis
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Injury, poisoning and procedural complications
Joint injury
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Investigations
C-reactive protein increased
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • Baseline to 16 week
|
25.0%
1/4 • Number of events 1 • Baseline to 16 week
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Baseline to 16 week
|
25.0%
1/4 • Number of events 1 • Baseline to 16 week
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Baseline to 16 week
|
25.0%
1/4 • Number of events 4 • Baseline to 16 week
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
33.3%
3/9 • Number of events 3 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
|
Skin and subcutaneous tissue disorders
Scab
|
11.1%
1/9 • Number of events 1 • Baseline to 16 week
|
0.00%
0/4 • Baseline to 16 week
|
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 clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER