Atopic DermatitisPhase 1NCT03826901
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
A Phase 1 study testing delgocitinib in people with Atopic Dermatitis, run by LEO Pharma at 16 sites in 2 countries.
Trial summary
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- delgocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 20 Feb 2019to 29 Oct 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
- Age 2-11 years at baseline
- History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
- AD involvement of ≥35% treatable BSA at screening and at baseline
- Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline
- Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above)
Show all 12Show fewer
- Active dermatologic conditions that may interfere with the diagnosis of AD
- Use of tanning beds or phototherapy within 4 weeks prior to baseline
- Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline
- Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline
- Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline
- Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial
Who cannot join
None listed.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States12 sites
LEO Pharma investigational site
Birmingham, Alabama, 35209
LEO Pharma investigational site
Centennial, Colorado, 80112
LEO Pharma investigational site
Fountain Valley, California, 92708
LEO Pharma investigational site
Indianapolis, Indiana, 46250
LEO Pharma investigational site
Irvine, California, 92697
LEO Pharma investigational site
Los Angeles, California, 90027
LEO Pharma investigational site
Medford, Oregon, 97504
LEO Pharma investigational site
New Haven, Connecticut, 06519
LEO Pharma investigational site
Phoenix, Arizona, 85006
LEO Pharma investigational site
San Antonio, Texas, 78218
LEO Pharma investigational site
Tulsa, Oklahoma, 74136
LEO Pharma investigational site
Ypsilanti, Michigan, 48197
Canada4 sites
LEO Pharma investigational site
Hamilton, Ontario, L8S 1G5
LEO Pharma investigational site
Montreal, Quebec, H2K 4L5
LEO Pharma investigational site
Montreal, Quebec, H3T 1C5
LEO Pharma investigational site
Red Deer, Alberta, 46-37535
About this study
Official title: A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
Read the detailed description
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- delgocitinib
- Keywords
- adults, pediatric
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delgocitinibDrug
Also called LEO 124249
Cream for topical application
| Study group | Role | What they receive |
|---|---|---|
| Part 1: adults and adolescents (12 years and above) | Experimental | Delgocitinib cream (dosage: A mg/g). Receives: Drug: delgocitinib |
| Part 2: children (2-11 years) | Experimental | Delgocitinib cream (dosage: B mg/g). Receives: Drug: delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Number of AEs and number of subjects with AEs
Measured: Week 0 to Week 8
Secondary outcomes (3)
PK parameter - Cmax
Cmax
Measured: at Day 8
PK parameter - AUC
AUC
Measured: at Day 8
PK parameter - tmax
tmax
Measured: at Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start20 Feb 2019
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT03826901
- Sponsor's protocol ID
- LP0133-1181
- Status last verified
- Nov 2021
- First submitted
- 30 Jan 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gooderham M, Bunick CG, Yu J, Maslin D, Schneider SKR, Osterdal ML, Sohoel A, Madsen DE, Eichenfield LF. Minimal Systemic Exposure with Maximal Delgocitinib Cream Use in Patients with Severe Chronic Hand Eczema in the DELTA 2 Randomized, Vehicle-Controlled, Double-Blind, Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jul;16(7):3275-3283. doi: 10.1007/s13555-026-01767-1. Epub 2026 May 17.
PubMed 42143645
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
- A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03826901
- Acronym / sponsor ID
- LP0133-1181
- Conditions
- Atopic Dermatitis
- Keywords
- adults, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 1 Feb 2019 (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.
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
Detailed description
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: adults and adolescents (12 years and above) | Experimental | Drug: delgocitinibDelgocitinib cream (dosage: A mg/g). |
| Part 2: children (2-11 years) | Experimental | Drug: delgocitinibDelgocitinib cream (dosage: B mg/g). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
- Age 2-11 years at baseline
- History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
- AD involvement of ≥35% treatable BSA at screening and at baseline
- Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| delgocitinibAlso: LEO 124249Cream for topical application | Drug | Part 1: adults and adolescents (12 years and above), Part 2: children (2-11 years) |
Primary outcome
Adverse events (AEs)
Time frame: Week 0 to Week 8
Number of AEs and number of subjects with AEs
3 secondary outcomes
PK parameter - Cmax
Time frame: at Day 8
PK parameter - AUC
Time frame: at Day 8
PK parameter - tmax
Time frame: at Day 8
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.
- Derived from this study: PubMed 42143645Gooderham M, Bunick CG, Yu J, Maslin D, Schneider SKR, Osterdal ML, Sohoel A, Madsen DE, Eichenfield LF. Minimal Systemic Exposure with Maximal Delgocitinib Cream Use in Patients with Severe Chronic Hand Eczema in the DELTA 2 Randomized, Vehicle-Controlled, Double-Blind, Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jul;16(7):3275-3283. doi: 10.1007/s13555-026-01767-1. Epub 2026 May 17.
- 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
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
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
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing delgocitinib in people with Atopic Dermatitis, run by LEO Pharma at 16 sites in 2 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 12 inclusion and 0 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 16 sites in United States, 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. 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?
Adverse events (AEs) (time frame: Week 0 to Week 8). 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 NCT03826901, which also lists 1 linked publication.
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.