Chronic Hand EczemaPhase 2NCT03683719
Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
A Phase 2 study testing Delgocitinib cream in people with Chronic Hand Eczema, run by LEO Pharma at 28 sites in 3 countries.
Trial summary
The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Delgocitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 28 Nov 2018to 20 Apr 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 or above.
- Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
- Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
- Diagnostic patch testing performed within 3 years prior to the screening visit.
Who cannot join
- Concurrent skin diseases on the hands e.g tinnea manuum.
- Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
- Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
- Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
- Receipt of live attenuated vaccines 4 weeks prior to baseline.
Show all 17Show fewer
- Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
- Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
- Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 1 week prior to baseline.
- Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 1 week prior to baseline.
- Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline or until cells count returns to normal, whichever is longer.
- Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
- Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening.
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications.
- Any disorder which is not stable and in the investigator's opinion could affect the safety of the subject, influence the findings of the trial, or impede the subject's ability to complete the trial.
- Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Germany20 sites
Leo Pharma Investigational Site
Berlin, 10117
Leo Pharma Investigational Site
Bochum, 44791
Leo Pharma Investigational Site
Bremerhaven, 27574
Leo Pharma Investigational Site
Dresden, 01307
Leo Pharma Investigational Site
Düsseldorf, 40225
Leo Pharma Investigational Site
Gera, 07548
Leo Pharma Investigational Site
Göttingen, 37075
Leo Pharma Investigational Site
Jena, 07743
Leo Pharma Investigational Site
Kiel, 24105
Leo Pharma Investigational Site
Kiel, 24148
Leo Pharma Investigational Site
Langenau, 89129
Leo Pharma Investigational Site
Lübeck, 23538
Leo Pharma Investigational Site
Mahlow, 15831
Leo Pharma Investigational Site
Mainz, 55101
Leo Pharma Investigational Site
Memmingen, 87700
Leo Pharma Investigational Site
München, 80337
Leo Pharma Investigational Site
Selters, 56242
Leo Pharma Investigational Site
Stuttgart, 70178
Leo Pharma Investigational Site
Stuttgart, 70499
Leo Pharma Investigational Site
Wuppertal, 42287
United States4 sites
Leo Pharma Investigational Site
Hialeah, Florida, 33012
Leo Pharma Investigational Site
Portland, Oregon, 97223
Leo Pharma Investigational Site
Portland, Oregon, 97239-4501
Leo Pharma Investigational Site
Tucson, Arizona, 85724
Denmark4 sites
Leo Pharma Investigational Site
Aarhus, 8200
Leo Pharma Investigational Site
Copenhagen, 2400
Leo Pharma Investigational Site
Hellerup, 2900
LEO Pharma Investigational Site
Herlev, 2730
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 Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema
The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
- Conditions
- Chronic Hand Eczema
- Being tested
- Delgocitinib cream, Delgocitinib cream vehicle
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 16 weeks. Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 3 mg/g | Experimental | Delgocitinib cream applied twice daily for 16 weeks. Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 8 mg/g | Experimental | Delgocitinib cream applied twice daily for 16 weeks. Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 20 mg/g | Experimental | Delgocitinib cream applied twice daily for 16 weeks. Receives: Drug: Delgocitinib cream |
| Delgocitinib cream vehicle | Placebo comparator | Delgocitinib cream vehicle applied twice daily for 16 weeks. Receives: Drug: Delgocitinib cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage 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 delgocitinib cream vehicle.
Measured: Week 0 to Week 16.
Secondary outcomes (2)
Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The lowest HECSI score is 0 and the highest possible is 360. A higher HECSI score is indicating more severe hand eczema.
The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. A mixed model for repeated measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib cream doses and delgocitinib cream vehicle.
Measured: Week 0 to Week 16.
Time to IGA-CHE Treatment Success.
Time to IGA-CHE treatment success response is defined as the time from baseline to first assessment of an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement.
Measured: 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.
- First posted25 Sep 2018
- Study start28 Nov 2018
- Primary completion6 Mar 2020
- Study completion20 Apr 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hand EczemaStudies 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
- 258 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
- NCT03683719
- Sponsor's protocol ID
- LP0133-1273
- Status last verified
- Apr 2021
- First submitted
- 21 Sep 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
Publications
Buhl T, Bauer A, Ehst BD, Thyssen JP, Hahn-Pedersen J, Hagen BF, Apol ED, Agner T. Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream. Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5.
PubMed 40186746Weisshaar E, Yuksel YT, Agner T, Larsen LS, Grant L, Arbuckle R, Jones AM, Fromy P, Balita-Crisostomo CL, Mathiasen NN, Thoning H, Apfelbacher C. Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS). Dermatol Ther (Heidelb). 2024 Nov;14(11):3047-3070. doi: 10.1007/s13555-024-01267-0. Epub 2024 Oct 21.
PubMed 39428453Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.
PubMed 38485862
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 Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema
- ClinicalTrials.gov ID
- NCT03683719
- Acronym / sponsor ID
- LP0133-1273
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
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 16 weeks. |
| Delgocitinib cream 3 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 16 weeks. |
| Delgocitinib cream 8 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 16 weeks. |
| Delgocitinib cream 20 mg/g | Experimental | Drug: Delgocitinib creamDelgocitinib cream applied twice daily for 16 weeks. |
| Delgocitinib cream vehicle | Placebo comparator | Drug: Delgocitinib cream vehicleDelgocitinib cream vehicle applied twice daily for 16 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 or above.
- Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
- Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
- Diagnostic patch testing performed within 3 years prior to the screening visit.
Key exclusion criteria (17 listed)
- Concurrent skin diseases on the hands e.g tinnea manuum.
- Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
- Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
- Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands 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
Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
Time frame: Week 0 to Week 16.
IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage 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 delgocitinib cream vehicle.
2 secondary outcomes
Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
Time frame: Week 0 to Week 16.
Time to IGA-CHE Treatment Success.
Time frame: Week 0 to Week 16.
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.
- Derived from this study: PubMed 40186746Buhl T, Bauer A, Ehst BD, Thyssen JP, Hahn-Pedersen J, Hagen BF, Apol ED, Agner T. Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream. Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5.
- Derived from this study: PubMed 39428453Weisshaar E, Yuksel YT, Agner T, Larsen LS, Grant L, Arbuckle R, Jones AM, Fromy P, Balita-Crisostomo CL, Mathiasen NN, Thoning H, Apfelbacher C. Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS). Dermatol Ther (Heidelb). 2024 Nov;14(11):3047-3070. doi: 10.1007/s13555-024-01267-0. Epub 2024 Oct 21.
- Derived from this study: PubMed 38485862Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.
- 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
28 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 Chronic Hand Eczema, run by LEO Pharma at 28 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 17 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 28 sites in Germany, United States, Denmark. 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 19 Apr 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?
Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) 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 NCT03683719, which also lists 3 linked publications.
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.