Atopic DermatitisPhase 2NCT05117060

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing LEO 152020 tablet in people with Atopic Dermatitis, run by JW Pharmaceutical at 45 sites in 8 countries.

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

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: LEO 152020 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 216 participants
Where: 45 sitesin 8 countries
Study dates: 13 Dec 2021to 26 Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult, age 18 years or older at screening.
Diagnosis of chronic atopic dermatitis (AD).
History of AD ≥1 year prior to baseline.
Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at baseline.

Who cannot join

Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
Previous treatment with 3 or more systemic AD treatments prior to screening.
Women who are pregnant, intend to become pregnant, or are lactating.

Trial locations and contacts

45 sites in 8 countries.

Country

City, postcode or hospital

45 sites in 8 countries

Canada8 sites

LEO Pharma Investigational Site
Calgary, Alberta, T2J 7E1
LEO Pharma Investigational Site
Calgary, Alberta, T3E 0B2
LEO Pharma Investigational Site
Edmonton, Alberta, T5J 3S9
LEO Pharma Investigational Site
Markham, Ontario, L3P 1X3
LEO Pharma Investigational Site
Mississauga, Ontario, L4Y 4C5
LEO Pharma Investigational Site
Niagara Falls, Ontario, L2H 1H5
LEO Pharma Investigational site
Québec, Quebec, G1V 4X7
LEO Pharma Investigational Site
Saint-Jérôme, Quebec, J7Z 7E2

Other trials in Canada

United States6 sites

LEO Pharma Investigational Site
Beverly Hills, California, 90212
LEO Pharma Investigational Site
Cincinnati, Ohio, 45219
LEO Pharma Investigational Site
Frisco, Texas, 75034
LEO Pharma Investigational Site
Los Angeles, California, 90045
LEO Pharma Investigational Site
Murfreesboro, Tennessee, 37130
LEO Pharma Investigational Site
San Diego, California, 92123

Other trials in United States

Australia6 sites

LEO Pharma Investigational Site
Carlton, Victoria, 3053
LEO Pharma Investigational Site
Clayton, Victoria, 3168
LEO Pharma Investigational Site
Darlinghurst, New South Wales, 2010
LEO Pharma Investigational Site
Kogarah, New South Wales, 2217
LEO Pharma Investigational Site
Sydney, New South Wales, 2010
LEO Pharma Investigational Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Japan6 sites

LEO Pharma Investigational Site
Fukuoka, Fukuoka, 812-8582
LEO Pharma Investigational Site
Fukutsu-shi, Fukuoka, 811-3217
LEO Pharma Investigational Site
Koto-ku, Tokyo, 136-0074
LEO Pharma Investigational Site
Kumamoto, Kumamoto, 861-4101
LEO Pharma Investigational Site
Minato-ku, Tokyo, 108-0014
LEO Pharma Investigational Site
Takatsuki-shi, Osaka, 569-0824

Other trials in Japan

Poland6 sites

LEO Pharma Investigational Site
Krakow, 30-033
LEO Pharma Investigational Site
Lodz, 90-436
LEO Pharma Investigational Site
Lublin, 20-081
LEO Pharma Investigational Site
Mikołów, 43-190
LEO Pharma Investigational Site
Wroclaw, 51-124
LEO Pharma Investigational Site
Wroclaw, 51-685

Other trials in Poland

Czechia5 sites

LEO Pharma Investigational Site
Karlovy Vary, 360 01
LEO Pharma Investigational Site
Kutná Hora, 284 01
LEO Pharma Investigational Site
Nový Jičín, 741 01
LEO Pharma Investigational Site
Ostrava-Poruba, 708 52
LEO Pharma Investigational Site
Prague, 100 34

Other trials in Czechia

Germany5 sites

LEO Pharma Investigational Site
Bad Bentheim, 48455
LEO Pharma Investigational Site
Berlin, 10789
LEO Pharma Investigational Site
Hanover, 30625
LEO Pharma Investigational Site
Magdeburg, 39120
LEO Pharma Investigational Site
Merzig, 66663

Other trials in Germany

Spain3 sites

LEO Pharma Investigational Site
Córdoba, 14004
LEO Pharma Investigational Site
Madrid, 28046
LEO Pharma Investigational Site
Pontevedra, 36001

Other trials in Spain

About this study

Official title: A Phase 2 Trial to Evaluate the Efficacy and Safety of Orally Administered LEO 152020 Tablets Compared With Placebo Tablets for up to 16 Weeks of Treatment in Adults With Moderate to Severe Atopic Dermatitis

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD).

The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient.

During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. 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, itch, sleep, and quality of life.

Conditions: Atopic Dermatitis
Being tested: LEO 152020 tablet, LEO 152020 placebo tablet
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 152020 tabletDrug
LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R) and prevent histamine from binding to the receptor. LEO 152020 is a tablet for oral administration.
LEO 152020 placebo tabletDrug
LEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.

Study groups in NCT05117060
Study group	Role	What they receive
LEO 152020 tablet - Dose regimen 1	Experimental	Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). Receives: Drug: LEO 152020 tablet
LEO 152020 tablet - Dose regimen 2	Experimental	Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). Receives: Drug: LEO 152020 tablet; Drug: LEO 152020 placebo tablet
LEO 152020 tablet - Dose regimen 3	Experimental	Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). Receives: Drug: LEO 152020 tablet; Drug: LEO 152020 placebo tablet
LEO 152020 placebo tablet	Placebo comparator	Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment). Receives: Drug: LEO 152020 placebo tablet

What is being measured

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

Change in EASI 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 or severe condition.
Measured: Week 0 to Week 16

Secondary outcomes (1)

Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
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).
Measured: Week 0 to Week 16+3 days

Timeline

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

13 Dec 202126 Jul 2023

First posted11 Nov 2021
Study start13 Dec 2021
Primary completion20 Jul 2023
Study completion26 Jul 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05117060
Sponsor's protocol ID: LP0190-1488
Other IDs: 2020-004561-39, U1111-1281-1895
Status last verified: May 2024
First submitted: 8 Nov 2021
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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

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
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Trial to Evaluate the Efficacy and Safety of Orally Administered LEO 152020 Tablets Compared With Placebo Tablets for up to 16 Weeks of Treatment in Adults With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT05117060
Acronym / sponsor ID: LP0190-1488
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: JW PharmaceuticalIndustry (pharma, biotech, devices)
Collaborators: LEO Pharma
Study start: 13 Dec 2021 (actual)
Primary completion: 20 Jul 2023 (actual)
Study completion: 26 Jul 2023 (actual)
First posted: 11 Nov 2021 (actual)
Results: Posted 31 May 2024

Clinical summary

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

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD).

The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
LEO 152020 tablet - Dose regimen 1	Experimental	Drug: LEO 152020 tabletParticipants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
LEO 152020 tablet - Dose regimen 2	Experimental	Drug: LEO 152020 tablet, Drug: LEO 152020 placebo tabletParticipants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
LEO 152020 tablet - Dose regimen 3	Experimental	Drug: LEO 152020 tablet, Drug: LEO 152020 placebo tabletParticipants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
LEO 152020 placebo tablet	Placebo comparator	Drug: LEO 152020 placebo tabletParticipants will be asked to take tablets from Week 0 to Week 16 (end of treatment).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult, age 18 years or older at screening.
Diagnosis of chronic atopic dermatitis (AD).
History of AD ≥1 year prior to baseline.
Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.

Key exclusion criteria (3 listed)

Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
Previous treatment with 3 or more systemic AD treatments prior to screening.
Women who are pregnant, intend to become pregnant, or are lactating.

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 152020 tabletLEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R) and prevent histamine from binding to the receptor. LEO 152020 is a tablet for oral administration.	Drug	LEO 152020 tablet - Dose regimen 1, LEO 152020 tablet - Dose regimen 2, LEO 152020 tablet - Dose regimen 3
LEO 152020 placebo tabletLEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except that it does not contain the medical ingredient LEO 152020. LEO 152020 placebo is a tablet for oral administration.	Drug	LEO 152020 placebo tablet, LEO 152020 tablet - Dose regimen 2, LEO 152020 tablet - Dose regimen 3

Primary outcome

Change in EASI 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 or severe condition.

1 secondary outcome

Number of Adverse Events From Baseline to Week 16+3 Days Per Subject
Time frame: Week 0 to Week 16+3 days

Results and safety

Results posted to the registry on 31 May 2024, 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 152020 - Dosing Regimen 1 (Higher Dose)	61	44
LEO 152020 - Dosing Regimen 2 (Middle Dose)	45	29
LEO 152020 - Dosing Regimen 3 (Lower Dose)	49	33
LEO 152020 - Placebo	61	46

Primary outcome: Change in EASI From Baseline to Week 16

Time frame: Week 0 to Week 16. Mean (95% Confidence Interval). Unit: score on a scale

Measure	LEO 152020 - Dosing Regimen 1 (Higher Dose) n = 61	LEO 152020 - Dosing Regimen 2 (Middle Dose) n = 45	LEO 152020 - Dosing Regimen 3 (Lower Dose) n = 49	LEO 152020 - Placebo n = 61
Value	-9.99 (-12.85 to -7.13)	-8.83 (-12.63 to -5.04)	-8.87 (-12.47 to -5.28)	-9.11 (-11.88 to -6.35)

Population analysed: FAS, full analysis set.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Week 0 to Week 16+3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 152020 - Dosing Regimen 1 (Higher Dose)	0 of 61 (0%)	29 of 61 (47.5%)	0 of 61
LEO 152020 - Dosing Regimen 2 (Middle Dose)	2 of 45 (4.4%)	24 of 45 (53.3%)	0 of 45
LEO 152020 - Dosing Regimen 3 (Lower Dose)	1 of 49 (2%)	23 of 49 (46.9%)	0 of 49
LEO 152020 - Placebo	0 of 61 (0%)	24 of 61 (39.3%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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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

45 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO 152020 tablet in people with Atopic Dermatitis, run by JW Pharmaceutical at 45 sites in 8 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 6 inclusion and 3 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Canada, United States, Australia, Japan, Poland and 3 more countries. 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 31 May 2024). 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 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?

On the ClinicalTrials.gov record for NCT05117060.

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 4 Jun 2024.