Atopic DermatitisPhase 2NCT05923099

A Trial to Evaluate the Efficacy and Safety of Different Doses 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 73 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 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: 262 participants
Where: 73 sitesin 11 countries
Study dates: 20 Sep 2023to 9 Apr 2025
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated informed consent has been obtained prior to any protocol related procedures.
18-75 years old (both included) at screening (Visit 1).
Willingness to comply with the clinical trial protocol.
At screening, diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD.
History of AD for ≥1 year.
Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with topical corticosteroid(s) (TCS) (±topical calcineurin inhibitor(s) (TCI) as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks).

Show all 11Show fewer

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.
Atopic Dermatitis Symptom Diary (ADSD) Worst Itch score (weekly average) ≥4 at baseline.
A woman of childbearing potential must use a highly effective form of birth control throughout the trial and for at least 18 weeks after last administration of IMP.

Who cannot join

Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the trial period.
Active dermatologic condition that could confound the diagnosis of AD or interfere with assessment of the treatment (e.g. scabies, contact dermatitis, rosacea, urticaria, or psoriasis).
History of cancer, with the following exceptions:
Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to screening.
Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to screening
History of or current immunodeficiency syndrome.

Show all 40Show fewer

History of anaphylaxis following any biologic therapy.
History of clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial.
Skin infection within 7 days prior to baseline
Positive HBsAg or positive anti-HCV AND positive HCV RNA at screening.
History of HIV infection or positive HIV serology at screening.
Evidence of active or latent tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment.
ALT or AST level ≥2.0 times the ULN at screening.
History of attempted suicide or is at significant risk of suicide (either in the opinion of the investigator or defined as a "yes" to suicidal ideation questions no. 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS Screening version).
Known or suspected hypersensitivity to any component(s) of the IMP.
Any disorder at screening and/or baseline, which is not stable in the opinion of the investigator, and could:
Affect the safety of the subject throughout the trial.
Influence the results of the trial.
Impede the subject's ability to complete the trial.
Any significant abnormal finding at screening and/or baseline which may, in the opinion of the investigator:
Put the subject at risk because of their participation in the trial.
Influence the results of the trial.
Influence the subject's ability to complete the trial.
Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
Women who are pregnant or breastfeeding.
Previous treatment with LEO 138559.
Previous exposure to fezakinumab (anti-IL-22 Ab).
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, corticosteroids (steroid eyedrops and inhaled or intranasal steroids are allowed), or JAK inhibitors within 28 days or 5 half-lives prior to baseline, whichever is longer.
Use of tanning beds or phototherapy, within 4 weeks prior to baseline.
Receipt of blood products within 28 days prior to screening.
Treatment with:
Any marketed or investigational biologic agents within 3 months or 5 half-lives, whichever is longer, prior to baseline.
Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
Treatment with TCS, TCI, topical PDE-4 inhibitors, topical JAK inhibitors, or other medicated topical treatments within 7 days prior to baseline.
Receipt of live attenuated vaccines 30 days prior to baseline.
Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half lives prior to randomization, whichever is longer.
Current participation in any other interventional clinical trial.
Previously randomized in this clinical trial.
Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
Subjects who are legally institutionalized.

Trial locations and contacts

73 sites in 11 countries.

Country

City, postcode or hospital

73 sites in 11 countries

United States12 sites

LEO Investigational Site
Ann Arbor, Michigan, 48103
LEO Investigational Site
Cincinnati, Ohio, 45219
LEO Investigational Site
Fountain Valley, California, 92708
LEO Investigational Site
Hialeah, Florida, 33012
LEO investigational site
Indianapolis, Indiana, 46250
LEO Investigational Site
Los Angeles, California, 90045
LEO Investigational Site
Mayfield Heights, Ohio, 44124
LEO investigational Site
New Albany, Indiana, 47150
LEO Investigational Site
New York, New York, 10029
LEO Investigational Site
North Charleston, South Carolina, 29420
LEO Investigational Site
Raleigh, North Carolina, 27609
LEO Investigational Site
San Francisco, California, 94115

Other trials in United States

Germany11 sites

LEO Investigational Site
Augsburg, 86179
LEO Investigational Site
Bad Bentheim, 48455
LEO Investigational Site
Berlin, 10117
LEO Investigational Site
Dresden, 01307
LEO Investigational Site
Frankfurt am Main, 60590
LEO Investigational Site
Freiburg im Breisgau, 79104
LEO Investigational Site
Gera, 07548
LEO Investigational Site
Kiel, 24105
LEO Investigational Site
Leipzig, 04103
LEO Investigational Site
Mahlow, 15831
LEO Investigational Site
Münster, 48149

Other trials in Germany

Canada8 sites

LEO Investigational Site
Calgary, Alberta, T2J 7E1
LEO Investigational Site
Calgary, Alberta, T2W 4X9
LEO Investigational Site
Edmonton, Albana, T5J 3S9
LEO Investigational Site
Edmonton, Alberta, T6G 1C3
LEO Investigational Site
Mississauga, Ontario, L4Y 4C5
LEO Investigational Site
Sherbrooke, Quebec, J1G 1X9
LEO Investigational Site
Surrey, British Columbia, V3R 6A7
LEO Investigational Site
Verdun, Quebec, H4G 3E7

Other trials in Canada

Japan8 sites

LEO Investigational Site
Fukuoka, Fukuoka, 815-8588
LEO Investigational Site
Kobe, Hyōgo, 657-0846
LEO Investigational Site
Koto-ku, Tokyo, 136-0074
LEO Investigational Site
Takaoka-shi, Toyama, 933-0871
LEO Investigational Site
Takatsuki-shi, Osaka, 569-0824
LEO Investigational Site
Tokyo, 167-0051
LEO Investigational Site
Yokohama, Kanagawa, 220-6208
LEO Investigational Site
Yokohama, Kanagawa, 231-0801

Other trials in Japan

Spain7 sites

LEO Investigational Site
Alcobendas, 5-28100
LEO Investigational Site
Alicante, 03010
LEO Investigational Site
Badalona, Barcelona, 08915
LEO Investigational Site
Barcelona, 08907
LEO Investigational Site
Córdoba, 14004
LEO Investigational Site
Madrid, 28046
LEO Investigational Site
Zaragoza, 50009

Other trials in Spain

Poland6 sites

LEO Investigational Site
Krakow, 30-033
LEO Investigational Site
Krakow, 31-011
LEO Investigational Site
Malbork, 82-200
LEO Investigational Site
Mikołów, 43-190
LEO Investigational Site
Wroclaw, Lower Silesian Voivodeship, 50-450
LEO Investigational Site
Wroclaw, 50-224

Other trials in Poland

United Kingdom6 sites

LEO Investigational Site
Edinburgh, EH16 4SA
LEO Investigational Site
Harrow, HA1 3UJ
LEO Investigational Site
London, E1 1FR
LEO Investigational Site
Manchester, M23 9QZ
LEO Investigational Site
Southampton, SO16 6YD
LEO Investigational Site
Walsall, WS2 9PS

Other trials in United Kingdom

France5 sites

LEO Investigational Site
Dijon, 21000
LEO Investigational Site
Martigues, Bouches-du-Rhône, 13500
LEO Investigational Site
Nice, 06000
LEO Investigational Site
Paris, 75010
LEO Investigational Site
Rouen, 76031

Other trials in France

Czechia4 sites

LEO Investigational Site
Náchod, 547 01
LEO Investigatonal Site
Ostrava-Poruba, 708 52
LEO Investigational Site
Prague, 100 34
LEO Investigational Site
Prague, 150 00

Other trials in Czechia

Hungary3 sites

LEO Investigational Site
Debrecen, 4032
LEO Investigational Site
Pécs, 7632
LEO Investigational Site
Szeged, 6720

Other trials in Hungary

Romania3 sites

LEO Investigational Site
Cluj-Napoca, 400152
LEO Investigational Site
Iași, 700291
LEO Investigational Site
Timișoara, 300757

Other trials in Romania

About this study

Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses.

The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks.

The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin.

At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.

LEO 138559 is also called "Temtokibart".

Conditions: Atopic Dermatitis
Being tested: 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
Also called LEO 138559 is also called "temtokibart"
LEO 138559 given by injection just under the skin
PlaceboDrug
Placebo given by injection just under the skin

Study groups in NCT05923099
Study group	Role	What they receive
Dose regimen 1	Experimental	Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16 Receives: Drug: LEO 138559
Dose regimen 2	Experimental	Dose B every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16 Receives: Drug: LEO 138559
Dose regimen 3	Experimental	Dose A at Week 0 and Week 2, then dose C every 2 weeks from Week 4 to Week 16 Receives: Drug: LEO 138559
Dose regimen 4	Experimental	Dose C at Week 0 and Week 2, then dose D every 2 weeks from Week 4 to Week 16 Receives: Drug: LEO 138559
Placebo regimen	Placebo comparator	Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16 Receives: Drug: Placebo

What is being measured

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

Percent Change in Eczema Area and Severity Index (EASI) Score
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
Measured: From baseline to Week 16

Secondary outcomes (1)

Number of Treatment-emergent Adverse Events (TEAEs)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP.
Measured: From baseline (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.

20 Sep 20239 Apr 2025

First posted28 Jun 2023
Study start20 Sep 2023
Primary completion11 Dec 2024
Study completion9 Apr 2025

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: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05923099
Sponsor's protocol ID: LP0145-2240
Other IDs: U1111-1286-0955, 2022-500777-14-00
Status last verified: Dec 2025
First submitted: 20 Jun 2023
Last updated: 12 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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

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
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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
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT05923099
Acronym / sponsor ID: LP0145-2240
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 20 Sep 2023 (actual)
Primary completion: 11 Dec 2024 (actual)
Study completion: 9 Apr 2025 (actual)
First posted: 28 Jun 2023 (actual)
Results: Posted 12 Feb 2026

Clinical summary

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

The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin.

LEO 138559 is also called "Temtokibart".

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Dose regimen 1	Experimental	Drug: LEO 138559Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16
Dose regimen 2	Experimental	Drug: LEO 138559Dose B every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16
Dose regimen 3	Experimental	Drug: LEO 138559Dose A at Week 0 and Week 2, then dose C every 2 weeks from Week 4 to Week 16
Dose regimen 4	Experimental	Drug: LEO 138559Dose C at Week 0 and Week 2, then dose D every 2 weeks from Week 4 to Week 16
Placebo regimen	Placebo comparator	Drug: PlaceboPlacebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Signed and dated informed consent has been obtained prior to any protocol related procedures.
18-75 years old (both included) at screening (Visit 1).
Willingness to comply with the clinical trial protocol.
At screening, diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD.
Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with topical corticosteroid(s) (TCS) (±topical calcineurin inhibitor(s) (TCI) as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks).

Key exclusion criteria (40 listed)

Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the trial period.
Active dermatologic condition that could confound the diagnosis of AD or interfere with assessment of the treatment (e.g. scabies, contact dermatitis, rosacea, urticaria, or psoriasis).
History of cancer, with the following exceptions:
History of or current immunodeficiency syndrome.
History of anaphylaxis following any biologic therapy.

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 138559Also: LEO 138559 is also called "temtokibart"LEO 138559 given by injection just under the skin	Drug	Dose regimen 1, Dose regimen 2, Dose regimen 3, Dose regimen 4
PlaceboPlacebo given by injection just under the skin	Drug	Placebo regimen

Primary outcome

Percent Change in Eczema Area and Severity Index (EASI) Score
Time frame: From baseline to Week 16
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.

1 secondary outcome

Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline (Week 0) to Week 16

Results and safety

Results posted to the registry on 12 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Regimen 1	52	40
Dose Regimen 2	53	45
Dose Regimen 3	52	40
Dose Regimen 4	53	38
Placebo Regimen	52	35

Primary outcome: Percent Change in Eczema Area and Severity Index (EASI) Score

Time frame: From baseline to Week 16. Least squares mean (95% Confidence Interval). Unit: percent of change

Measure	Dose Regimen 1 n = 52	Dose Regimen 2 n = 53	Dose Regimen 3 n = 52	Dose Regimen 4 n = 53	Placebo Regimen n = 52
Value	-61.15 (-71.38 to -50.91)	-57.05 (-67.13 to -46.96)	-64.27 (-74.55 to -53.99)	-51.42 (-61.91 to -40.92)	-41.74 (-52.18 to -31.31)

Dose Regimen 1 vs Placebo Regimen: Mean Difference (Net): -19.40 (95% CI -33.96 to -4.84), p = 0.0090, ANCOVA
Dose Regimen 2 vs Placebo Regimen: Mean Difference (Net): -15.3 (95% CI -29.85 to -0.75), p = 0.0393, ANCOVA
Dose Regimen 3 vs Placebo Regimen: Mean Difference (Net): -22.52 (95% CI -37.18 to -7.87), p = 0.0026, ANCOVA

Population analysed: For the primary efficacy endpoint, analyzed population was Full Analysis Set (FAS).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Regimen 1	1 of 52 (1.9%)	27 of 52 (51.9%)	0 of 52
Dose Regimen 2	2 of 53 (3.8%)	27 of 53 (50.9%)	0 of 53
Dose Regimen 3	1 of 52 (1.9%)	24 of 52 (46.2%)	0 of 52
Dose Regimen 4	2 of 53 (3.8%)	31 of 53 (58.5%)	0 of 53
Placebo Regimen	0 of 52 (0%)	21 of 52 (40.4%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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
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RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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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
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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

73 sites in 11 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 73 sites in 11 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 11 inclusion and 40 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Germany, Canada, Japan, Spain and 6 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 12 Feb 2026). 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?

Percent Change in Eczema Area and Severity Index (EASI) Score (time frame: From baseline 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 NCT05923099.

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 12 Feb 2026.