Atopic DermatitisPhase 2NCT04922021
An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
A Phase 2 study testing LEO 138559 in people with Atopic Dermatitis, run by LEO Pharma at 17 sites in 4 countries.
Trial summary
This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 138559
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 14 Jul 2021to 26 Sep 2022
- 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
- 18-64 years old (both included) at screening.
- Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology 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.
- Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline.
- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline.
- Body surface area (BSA) of AD involvement ≥10% at screening and baseline.
- Worst Daily Pruritus Numeric Rating Scale (NRS, weekly average) of ≥3 points at baseline.
Who cannot join
- Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer.
- Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer.
- Treatment with topical corticosteroid(s) (TCS), topical calcineurin inhibitor(s) (TCI), topical phosphodiesterase-4 (PDE-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization.
- Treatment with a live (attenuated) vaccine within 12 weeks prior to randomization.
- Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject.
- Skin infection within 1 week prior to the baseline visit.
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- Presence of hepatitis B or C infection at screening.
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- Participant has a positive or indeterminate test for tuberculosis at screening.
- Participant is pregnant or lactating.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States5 sites
LEO Pharma Investigational Site
Birmingham, Alabama, 35209
LEO Pharma Investigational Site
Doral, Florida, 33122
LEO Pharma Investigational Site
Fountain Valley, California, 92708
LEO Pharma Investigational Site
Hialeah, Florida, 33012
LEO Pharma Investigational Site
Los Angeles, California, 90045
Poland5 sites
LEO Pharma Investigational Site
Krakow, 30-033
LEO Pharma Investigational Site
Krakow, 31-011
LEO Pharma nvestigational Site
Rzeszów, 35-055
LEO Pharma Investigational Site
Warsaw, 02-625
LEO Pharma Investigational Site
Wroclaw, 51-685
Germany4 sites
LEO Pharma Investigational Site
Berlin, 10117
LEO Pharma Investigational Site
Dresden, 01307
LEO Pharma Investigational Site
Leipzig, 04103
LEO Pharma Investigational Site
Lübeck, 23538
Canada3 sites
LEO Pharma Investigational Site
Markham, Ontario, L3P 1X3
LEO Pharma Investigational Site
Mississauga, Ontario, L5H 1G9
LEO Pharma Investigational Site
Peterborough, Ontario, K9J 5K2
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).
This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD).
The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient.
The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.
- Conditions
- Atopic Dermatitis
- Being tested
- LEO 138559, LEO 138559 placebo
- 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 injection just under the skin.
LEO 138559 placeboDrug
LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
| Study group | Role | What they receive |
|---|---|---|
| LEO 138559 | Experimental | Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). Receives: Drug: LEO 138559 |
| Placebo | Placebo comparator | Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). Receives: Drug: LEO 138559 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EASI Score From Baseline to Week 16
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 and/or severe condition.
Measured: Week 0 to Week 16
Secondary outcomes (1)
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Measured: Week 0 to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start14 Jul 2021
- Primary completion2 Jun 2022
- Study completion26 Sep 2022
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922021
- Sponsor's protocol ID
- LP0145-1376
- Other IDs
- 2020-005541-16
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2021
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).
- ClinicalTrials.gov ID
- NCT04922021
- Acronym / sponsor ID
- LP0145-1376
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 24 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD).
The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient.
The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.
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 will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). |
| Placebo | Placebo comparator | Drug: LEO 138559 placeboParticipants will receive injections of placebo 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 (7 listed)
- 18-64 years old (both included) at screening.
- Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology 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.
- Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline.
- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline.
Key exclusion criteria (10 listed)
- Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer.
- Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer.
- Treatment with topical corticosteroid(s) (TCS), topical calcineurin inhibitor(s) (TCI), topical phosphodiesterase-4 (PDE-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization.
- Treatment with a live (attenuated) vaccine within 12 weeks prior to randomization.
- Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject.
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 injection just under the skin. | Drug | LEO 138559 |
| LEO 138559 placeboLEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559. | Drug | Placebo |
Primary outcome
Change in EASI Score From Baseline to Week 16
Time frame: Week 0 to Week 16
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 and/or severe condition.
1 secondary outcome
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Week 0 to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 138559 in people with Atopic Dermatitis, run by LEO Pharma at 17 sites in 4 countries.
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 7 inclusion and 10 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 13 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 17 sites in United States, Poland, Germany, Canada. 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. Some participants in this study may receive a placebo. 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 24 Jul 2023). 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 EASI Score From Baseline to Week 16 (time frame: Week 0 to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.