Atopic DermatitisPhase 2NCT03725722
Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
A Phase 2 study testing Delgocitinib cream in people with Atopic Dermatitis, run by LEO Pharma at 31 sites in 3 countries.
Trial summary
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD). 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?
- Delgocitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 28 Dec 2018to 19 May 2020
- 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
- Age 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- History of AD for ≥1 year.
- AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
- Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.
Who cannot join
- AD lesion(s) on scalp at screening and/or baseline.
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity 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, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
Show all 11Show fewer
- Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
- Receipt of live attenuated vaccines within 4 weeks prior to baseline.
- Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
- History of any active skin infection within 1 week prior to baseline.
- Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Canada13 sites
Leo Pharma Investigational Site
Barrie, Ontario, L4M 7G1
Leo Pharma Investigational Site
Calgary, Alberta, T3A 2N1
Leo Pharma Investigational Site
Edmonton, Alberta, T5K 1X3
Leo Pharma Investigational Site
Fredericton, New Brunswick, E3B 1G9
Leo Pharma Investigational Site
Markham, Ontario, L3P 1X2
Leo Pharma Investigational Site
Mississauga, Ontaria, L5H 1G9
Leo Pharma Investigational Site
Peterborough, Ontario, K9J 5K2
Leo Pharma Investigational Site
Richmond Hill, Ontario, L4C 9M7
Leo Pharma Investigational Site
Surrey, British Columbia, V3R 6A7
Leo Pharma Investigational Site
Toronto, Ontario, M2M 4J5
Leo Pharma Investigational Site
Toronto, Ontario, M2W 2N2
Leo Pharma Investigational Site
Toronto, Ontario, M3H 5Y8
Leo Pharma Investigational Site
Winnipeg, Manitoba, R3M 3Z4
United States11 sites
Leo Pharma Investigational Site
Birmingham, Alabama, 35209
Leo Pharma Investigational Site
Chicago, Illinois, 60611
Leo Pharma Investigational Site
Detroit, Michigan, 48202
Leo Pharma Investigational Site
Encino, California, 91436
Leo Pharma Investigational Site
High Point, North Carolina, 27262
Leo Pharma Investigational Site
Los Angeles, California, 90033
Leo Pharma Investigational Site
Los Angeles, California, 90045
Leo Pharma Investigational Site
New York, New York, 10019
Leo Pharma Investigational Site
Philadelphia, Pennsylvania, 19104
Leo Pharma Investigational Site
Rolling Hills Estates, California, 90274-7604
Leo Pharma Investigational Site
Santa Ana, California, 92701
Australia7 sites
Leo Pharma Investigational Site
Carlton, 3053
Leo Pharma Investigational Site
Darlinghurst, 2010
Leo Pharma Investigational Site
East Melbourne, 3002
Leo Pharma Investigational Site
Hectorville, 5073
Leo Pharma Investigational Site 1
Kogarah, 2217
Leo Pharma Investigational Site
Kogarah, 2217
Leo Pharma Investigational Site
Woolloongabba, 4102
About this study
Official title: A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- Delgocitinib cream, Delgocitinib cream vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib creamDrug
Also called LEO 124249 cream
Cream for topical application
Delgocitinib cream vehicleDrug
Also called LEO 124249 cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib cream 1 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 3 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 8 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 20 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks Receives: Drug: Delgocitinib cream |
| Delgocitinib cream vehicle | Placebo comparator | Delgocitinib cream vehicle applied twice daily for 8 weeks Receives: Drug: Delgocitinib cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.
The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
Measured: Week 0 to Week 8
Secondary outcomes (3)
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.
vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose-selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and the delgocitinib cream vehicle.
Measured: Week 0 to Week 8
EASI75 at Week 8
EASI75 is defined as at least 75% reduction in EASI from baseline.
Measured: Week 0 to Week 8
Time to vIGA-AD TS
The time to vIGA-AD TS response is defined as the time from baseline to first assessment of a vIGA-AD score of 0 (Clear) or 1 (Almost Clear) with ≥2-step improvement
Measured: Week 0 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start28 Dec 2018
- Primary completion19 May 2020
- Study completion19 May 2020
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
- 251 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
- NCT03725722
- Sponsor's protocol ID
- LP0133-1275
- Status last verified
- Jun 2021
- First submitted
- 30 Oct 2018
- Last updated
- 12 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT03725722
- Acronym / sponsor ID
- LP0133-1275
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 8 Jul 2021
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 double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib cream 1 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 8 weeks |
| Delgocitinib cream 3 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 8 weeks |
| Delgocitinib cream 8 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 8 weeks |
| Delgocitinib cream 20 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 8 weeks |
| Delgocitinib cream vehicle | Placebo comparator | Drug: Delgocitinib cream vehicleDelgocitinib cream vehicle applied twice daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- History of AD for ≥1 year.
- AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
- Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.
Key exclusion criteria (11 listed)
- AD lesion(s) on scalp at screening and/or baseline.
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity 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.
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 |
|---|---|---|
| Delgocitinib creamAlso: LEO 124249 creamCream for topical application | Drug | Delgocitinib cream 1 mg/g, Delgocitinib cream 20 mg/g, Delgocitinib cream 3 mg/g, Delgocitinib cream 8 mg/g |
| Delgocitinib cream vehicleAlso: LEO 124249 cream vehicleThe cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. | Drug | Delgocitinib cream vehicle |
Primary outcome
Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
Time frame: Week 0 to Week 8
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
3 secondary outcomes
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.
Time frame: Week 0 to Week 8
EASI75 at Week 8
Time frame: Week 0 to Week 8
Time to vIGA-AD TS
Time frame: Week 0 to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delgocitinib cream in people with Atopic Dermatitis, run by LEO Pharma at 31 sites in 3 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 5 inclusion and 11 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 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 31 sites in Canada, United States, Australia. 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 8 Jul 2021). 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 From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score. (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?
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 Mar 2025.