Atopic DermatitisPhase 1NCT03514511
Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis
A Phase 1 study testing LEO 138559 in people with Atopic Dermatitis, run by LEO Pharma at 3 sites in United Kingdom.
Trial summary
The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis. The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LEO 138559
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 7 May 2018to 2 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For healthy subjects and subjects with atopic dermatitis:
- Males and females without childbearing potential.
- Age between 18 and 55, inclusive.
- Body mass index between 18 and 32 kg/m2, inclusive.
- Healthy apart from atopic dermatitis for the subjects presenting the disease.
- For subjects with atopic dermatitis only:
- History of atopic dermatitis for more than 6 months.
- Female subjects with childbearing potential and male subjects with female partners with childbearing potential using highly effective contraception from start of the trial and until a period after the last administered dose of trial drug.
Who cannot join
- For healthy subjects and subjects with atopic dermatitis:
- Any significant disease detected prior to enrolment.
- Subjects who are still participating in a clinical trial or who have participated in a clinical trial within 3 months prior to enrolment or within 5 times of the half-life of the experimental therapy, whichever is longer.
- Skin diseases that may interfere with the diagnosis of atopic dermatitis or assessment of the treatment.
- Use of tanning beds or phototherapy within 6 weeks prior to enrolment.
- Subjects with atopic dermatitis requiring more than 3 bleach baths from 4 weeks prior to screening until end of trial.
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- Blood pressure or pulse rate outside of the normal range.
- For subjects with atopic dermatitis only:
- Initiation of treatment of atopic dermatitis with prescription emollients during the screening period.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Investigational site
Leeds
Investigational site
Liverpool
LEO Pharma investigational site
Manchester
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEO 138559 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis
The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.
The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis.
Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject).
Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).
- 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 a compound in development at LEO Pharma A/S
LEO 138559 placeboDrug
LEO 138559 placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 in healthy subjects | Experimental | LEO 138559 (dose regiment 1) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 2 in healthy subjects | Experimental | LEO 138559 (dose regiment 2) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 3 in healthy subjects | Experimental | LEO 138559 (dose regiment 3) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 4 in healthy subjects | Experimental | LEO 138559 (dose regiment 4) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 5 in healthy subjects | Experimental | LEO 138559 (dose regiment 5) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 6 in healthy subjects | Experimental | LEO 138559 (dose regiment 6) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 7 in healthy subjects | Experimental | LEO 138559 (dose regiment 7) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 8 in subjects with atopic dermatitis | Experimental | LEO 138559 (dose regiment 8) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
| Cohort 9 in subjects with atopic dermatitis | Experimental | LEO 138559 (dose regiment 9) or LEO 138559 placebo Receives: Drug: LEO 138559; Drug: LEO 138559 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LEO 138559 - numbers of subjects with adverse events
Measured: Day 1 to Day 120
Safety of LEO 138559 - number of adverse events
Measured: Day 1 to Day 120
Tolerability of LEO 138559 - number of local site reactions
Measured: Day 1 to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start7 May 2018
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514511
- Sponsor's protocol ID
- LP0145-1315
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2018
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEO 138559 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03514511
- Acronym / sponsor ID
- LP0145-1315
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.
The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis.
Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject).
Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 1) or LEO 138559 placebo |
| Cohort 2 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 2) or LEO 138559 placebo |
| Cohort 3 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 3) or LEO 138559 placebo |
| Cohort 4 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 4) or LEO 138559 placebo |
| Cohort 5 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 5) or LEO 138559 placebo |
| Cohort 6 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 6) or LEO 138559 placebo |
| Cohort 7 in healthy subjects | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 7) or LEO 138559 placebo |
| Cohort 8 in subjects with atopic dermatitis | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 8) or LEO 138559 placebo |
| Cohort 9 in subjects with atopic dermatitis | Experimental | Drug: LEO 138559, Drug: LEO 138559 placeboLEO 138559 (dose regiment 9) or LEO 138559 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females without childbearing potential.
- Age between 18 and 55, inclusive.
- Body mass index between 18 and 32 kg/m2, inclusive.
- Healthy apart from atopic dermatitis for the subjects presenting the disease.
- History of atopic dermatitis for more than 6 months.
Key exclusion criteria (9 listed)
- Any significant disease detected prior to enrolment.
- Subjects who are still participating in a clinical trial or who have participated in a clinical trial within 3 months prior to enrolment or within 5 times of the half-life of the experimental therapy, whichever is longer.
- Skin diseases that may interfere with the diagnosis of atopic dermatitis or assessment of the treatment.
- Use of tanning beds or phototherapy within 6 weeks prior to enrolment.
- Subjects with atopic dermatitis requiring more than 3 bleach baths from 4 weeks prior to screening until end of trial.
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 a compound in development at LEO Pharma A/S | Drug | Cohort 1 in healthy subjects, Cohort 2 in healthy subjects, Cohort 3 in healthy subjects, Cohort 4 in healthy subjects, Cohort 5 in healthy subjects, Cohort 6 in healthy subjects, Cohort 7 in healthy subjects, Cohort 8 in subjects with atopic dermatitis, Cohort 9 in subjects with atopic dermatitis |
| LEO 138559 placeboLEO 138559 placebo | Drug | Cohort 1 in healthy subjects, Cohort 2 in healthy subjects, Cohort 3 in healthy subjects, Cohort 4 in healthy subjects, Cohort 5 in healthy subjects, Cohort 6 in healthy subjects, Cohort 7 in healthy subjects, Cohort 8 in subjects with atopic dermatitis, Cohort 9 in subjects with atopic dermatitis |
Primary outcome
Safety of LEO 138559 - numbers of subjects with adverse events
Time frame: Day 1 to Day 120
Safety of LEO 138559 - number of adverse events
Time frame: Day 1 to Day 120
Tolerability of LEO 138559 - number of local site reactions
Time frame: Day 1 to Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- 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.
Study Director study director
LEO Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 138559 in people with Atopic Dermatitis, run by LEO Pharma at 3 sites in United Kingdom.
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 8 inclusion and 9 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of LEO 138559 - numbers of subjects with adverse events (time frame: Day 1 to Day 120). The study lists 3 primary outcomes in all. 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 24 Feb 2025.