Atopic DermatitisPhase 2NCT05470114

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD

A Phase 2 study testing LEO 138559 and Dupixent® in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: LEO 138559 and Dupixent®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteAustria
Study dates: 19 May 2022to 9 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosis of AD [as defined by the American Academy of Dermatology (AAD) Consensus Criteria] that has been present for ≥1 year prior to screening.
Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable.
EASI score ≥12 at screening and ≥16 at baseline.
vIGA-AD score ≥3 at screening and baseline.
Body surface area (BSA) of AD involvement ≥10% at screening and baseline.
Worst Daily Pruritus NRS (weekly average) of ≥3 points at baseline.

Who cannot join

Treatment with systemic immunosuppressive/immunomodulating medication (excluding systemic antihistamines if taken at stable dose already before baseline), e.g., JAK inhibitors, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to baseline, whichever is longer.
Treatment with systemic corticosteroids within 4 weeks prior to baseline (NOTE: Inhaled or intranasal steroids equivalent to doses including and up to 500 µg beclometasone (or equivalent) daily is allowed).
Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to baseline, whichever is longer.
Treatment with TCS, TCI, or topical PDE-4 inhibitor within 1 week prior to baseline (NOTE: Patient may be rescreened (one time) if failed for this criterion.
Intake of nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to baseline. Intake of paracetamol will be allowed.
Treatment with a live (attenuated) vaccine within 12 weeks prior to baseline.

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Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to baseline that may compromise the safety of the subject.
Clinically significant abnormalities detected on vital signs or ECG (apart from 1st degree atrioventricular (AV) block that is allowed).
Serious heart conditions, chronic lung diseases.
Acute asthma, acute bronchospasm, moderate to severe asthma.
Skin infection within 1 week prior to the baseline visit.
Presence of hepatitis B or C infection at screening.
Active inflammatory bowel disease (IBD) or history of IBD, anaphylaxis, immune complex disease, pancreatic disease, zoster infections, viral skin infections (including eczema herpeticum) or known or suspected history of immunosuppressive disorder.
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Subject has a positive test for tuberculosis at screening.
Subject is pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Austria1 site

LEO Investigational Site
Vienna, 1090

Other trials in Austria

About this study

Official title: A Randomized, Double-blinded, Active Comparator-controlled, 16-week, Single-site, Exploratory, Mechanistic Trial to Assess the Effect of LEO 138559 on the Molecular Signature and Safety in Adults With Moderate to Severe Atopic Dermatitis.

This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection.

The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®.

The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

Conditions: Atopic Dermatitis
Being tested: LEO 138559, Dupixent®
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 138559Drug
LEO 138559 is an antibody given by subcutaneous injection.
Dupixent®Drug
Dupixent® is an antibody given by subcutaneous injection.

Study groups in NCT05470114
Study group	Role	What they receive
LEO 138559	Experimental	Participants received injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). Receives: Drug: LEO 138559
Dupixent®	Active comparator	Participants received injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment). Receives: Drug: Dupixent®

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
Measured: From baseline to week 4

Secondary outcomes (1)

Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Measured: Between baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 20229 Oct 2023

First posted22 Jul 2022
Study start19 May 2022
Primary completion7 Jun 2023
Study completion9 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470114
Sponsor's protocol ID: LP0145-2274
Other IDs: 2021-006211-28
Status last verified: Nov 2024
First submitted: 19 May 2022
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Active Comparator-controlled, 16-week, Single-site, Exploratory, Mechanistic Trial to Assess the Effect of LEO 138559 on the Molecular Signature and Safety in Adults With Moderate to Severe Atopic Dermatitis.
ClinicalTrials.gov ID: NCT05470114
Acronym / sponsor ID: LP0145-2274
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 19 May 2022 (actual)
Primary completion: 7 Jun 2023 (actual)
Study completion: 9 Oct 2023 (actual)
First posted: 22 Jul 2022 (actual)
Results: Posted 14 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®.

The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LEO 138559	Experimental	Drug: LEO 138559Participants received injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
Dupixent®	Active comparator	Drug: Dupixent®Participants received injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Diagnosis of AD [as defined by the American Academy of Dermatology (AAD) Consensus Criteria] that has been present for ≥1 year prior to screening.
Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable.
EASI score ≥12 at screening and ≥16 at baseline.
vIGA-AD score ≥3 at screening and baseline.
Body surface area (BSA) of AD involvement ≥10% at screening and baseline.

Key exclusion criteria (16 listed)

Treatment with systemic immunosuppressive/immunomodulating medication (excluding systemic antihistamines if taken at stable dose already before baseline), e.g., JAK inhibitors, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to baseline, whichever is longer.
Treatment with systemic corticosteroids within 4 weeks prior to baseline (NOTE: Inhaled or intranasal steroids equivalent to doses including and up to 500 µg beclometasone (or equivalent) daily is allowed).
Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to baseline, whichever is longer.
Treatment with TCS, TCI, or topical PDE-4 inhibitor within 1 week prior to baseline (NOTE: Patient may be rescreened (one time) if failed for this criterion.
Intake of nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to baseline. Intake of paracetamol will be allowed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LEO 138559LEO 138559 is an antibody given by subcutaneous injection.	Drug	LEO 138559
Dupixent®Dupixent® is an antibody given by subcutaneous injection.	Drug	Dupixent®

Primary outcome

Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Time frame: From baseline to week 4
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression

1 secondary outcome

Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Between baseline and week 16

Results and safety

Results posted to the registry on 14 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LEO 138559	9	7
Dupixent®	4	4

Primary outcome: Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4

Time frame: From baseline to week 4. Mean (Standard Deviation). Unit: fold change

Measure	LEO 138559 n = 8	Dupixent® n = 4
Keratinocytes S100A7	0.212 (7.692)	0.043 (8.899)
Keratinocytes S100A8	0.155 (6.308)	0.048 (5.367)
Keratinocytes S100A9	0.149 (5.52)	0.02 (13.99)
Keratinocytes KRT6A	0.164 (4.08)	0.088 (1.459)
Keratinocytes KRT16	0.246 (2.75)	0.094 (1.731)
Keratinocytes KRT1	1.355 (1.748)	0.851 (5.008)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to 16 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 138559	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
Dupixent®	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Expert study director

LEO Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO 138559 and Dupixent® in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4 (time frame: From baseline to week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.