Chronic Hand EczemaPhase 3NCT06004050
A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema
A Phase 3 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 37 sites in China.
Trial summary
The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 37 sitesChina
- Study dates
- 5 Sep 2023to 12 Sep 2025
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or above at screening for adult participants and age 12-17 years at screening and baseline for adolescent participants.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
- HESD itch score (weekly average) of ≥4 points at baseline. The baseline weekly average will be calculated from daily assessments of itch severity during the 7 days immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 itch scores out of the 7 days is required to calculate the baseline average score.
- Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGACHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent), applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.
- Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.
- Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
- A woman of childbearing potential (WOCBP) must use an acceptable method of birth control throughout the trial up until the last application of investigational medicinal product (IMP).
Who cannot join
- Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
- Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
- Clinically significant infection (e.g. impetiginized hand eczema) on the hands.
- Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the investigational medicinal product (IMP), or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
- A systemic infection.
- A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
Show all 39Show fewer
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
- History of cancer:
- Participants 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 participant is in remission and curative therapy was completed at least 12 months prior to screening.
- Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to screening.
- Any disorder which is not stable and could:
- Affect the safety of the participant throughout the trial.
- Impede the participant's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, immunological, and psychiatric disorders, and major physical impairment.
- Any abnormal finding which may:
- Put the participant at risk because of their participation in the trial.
- Influence the participant's ability to complete the trial. The abnormal finding must be clinically significant and observed during the screening period. Examples include abnormal findings in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis.
- Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0×ULN at screening.
- Known or suspected hypersensitivity to any component(s) of the IMP.
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), traditional Chinese medicines (TCMs) (including herbals), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
- Use of tanning beds, phototherapy (e.g. UVB, UVA1, PUVA), or bleach baths on the handswithin 28 days prior to baseline.
- Previous or current treatment with Janus Kinase (JAK) inhibitors (including delgocitinib/LEO 124249),systemic or topical.
- Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus), TCMs (including herbals), or TCS on the hands within 14 days prior to baseline.
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
- Other transdermal or cutaneously applied therapy on the hands (except for the use of participant's own emollients) within 7 days 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 7 days prior to baseline.
- Treatment with any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, and dupilumab):
- 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.
- Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- Treatment with any non-marketed drug substance (that is, an agent that has not yet been made available for clinical use following registration) within the last 28 days prior to baseline or 5 half-lives, whichever is longer.
- Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalization during the trial period.
- Current participation in any other interventional clinical trial.
- Previously randomized in this clinical trial.
- Concurrent skin diseases on the hands, e.g. tinea manuum.
- Active psoriasis on any part of the body.
- Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
- 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.
- Participants who are legally institutionalized.
- Women who are pregnant or lactating.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
China37 sites
LEO Pharma Investigational Site
Beijing, 100044
LEO Pharma Investigational Site
Beijing, 100050
LEO Pharma Investigational Site
Beijing, 100080
LEO Pharma Investigational Site
Beijing, 100730
LEO Pharma Investigational Site
Changchun, 130021
LEO Pharma Investigational Site
Changsha, 410008
LEO Pharma Investigational Site
Changsha, 410011
LEO Pharma Investigational Site
Changzhou, 213000
LEO Pharma Investigational Site
Chengdu, 610021
LEO Pharma Investigational Site
Chengdu, 610044
LEO Pharma Investigational Site
Fuzhou, 350005
LEO Pharma Investigational Site
Guangzhou, 510030
LEO Pharma Investigational Site
Guangzhou, 510260
LEO Pharma Investigational Site
Guiyang, 550004
LEO Pharma Investigational Site
Hangzhou, 310003
LEO Pharma Investigational Site
Hangzhou, 310006
LEO Pharma Investigational Site
Hangzhou, 310014
LEO Pharma Investigational Site
Hefei, 230601
LEO Pharma Investigational Site
Nanchang, 330200
LEO Pharma Investigational Site
Nanjing, 210003
LEO Pharma Investigational Site
Nanyang, 473112
LEO Pharma Investigational Site
Shanghai, 200443
LEO Pharma Investigational Site
Shenyang, 110002
LEO Pharma Investigational Site
Shenzhen, 518020
LEO Pharma Investigational Site
Shenzhen, 518033
LEO Pharma Investigational Site
Shenzhen, 518052
LEO Pharma Investigational Site
Shenzhen, 518058
LEO Pharma Investigational Site
Shijiazhuang, 050030
LEO Pharma Investigational Site
Wenzhou, 325000
LEO Pharma Investigational Site
Wuhan, 430023
LEO Pharma Investigational Site
Wuhan, 430030
LEO Pharma Investigational Site
Wuhan, 430071
LEO Pharma Investigational Site
Wuxi, 214043
LEO Pharma Investigational Site
Xianyang, 712000
LEO Pharma Investigational Site
Yinchuan, 750003
LEO Pharma Investigational Site
Yiwu, 322000
LEO Pharma Investigational Site
Zhenjiang, 212000
About this study
Official title: A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema
The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).
Read the detailed description
The trial comprises of a 16-week double-blind, treatment period, followed by an open label treatment period of 36 weeks. In the double-blind treatment period two thirds of participants will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle. In the double-blind treatment period, participants will use delgocitinib twice a day. In the open label period, participants will only use delgocitinib when needed (if their CHE flares up). Some participants will also give blood samples at the start of the trial for pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.
- Conditions
- Chronic Hand Eczema
- Being tested
- Delgocitinib, Vehicle cream
- Keywords
- Dermatologic Disease, Dermatology, Eczema, Chronic Hand Eczema, Delgocitinib
- Medical subject headings
- Skin Diseases, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Topical administration
Vehicle creamOther
Topical administration
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind Period: Twice-Daily Delgocitinib Cream | Experimental | 20 mg/g twice daily Receives: Drug: Delgocitinib |
| Double-Blind Period: Twice-Daily Vehicle Cream | Placebo comparator | 20 mg/g twice daily Receives: Other: Vehicle cream |
| Open Label Period: Twice-Daily Delgocitinib | Experimental | 20 mg/g twice daily Receives: Drug: Delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.
Measured: Week 16
Secondary outcomes (18)
Hand Eczema Severity Index (HECSI)-90 at Week 16
Defined as at least a 90% improvement in HECSI score from baseline.
Measured: Week 16
HECSI-75 at Week 16
Defined as at least a 75% improvement in HECSI score from baseline.
Measured: Week 16
Percentage Change in HECSI Score From Baseline to Week 16
HECSI score is used to rate the severity of hand eczema and ranges from 0 (lowest possible score) to 360 (highest possible score).
Measured: Baseline and Week 16
Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16
Measured: Baseline and Week 16
Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16
Measured: Baseline and Week 16
Number of Participants With Reduction of HESD Pain Score by ≥4 Points From Baseline at Week 16
Measured: Baseline and Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
Measured: Baseline and Week 16
Change in HESD Score From Baseline to Week 16
Measured: Baseline and Week 16
Change in HESD Itch Score From Baseline to Week 16
Measured: Baseline and Week 16
Change in HESD Pain Score From Baseline to Week 16
Measured: Baseline and Week 16
Change in Hand Eczema Impact Scale (HEIS) Score
Measured: Baseline and Week 16
Change in HEIS Proximal Daily Activity Limitations (PDAL) Score
Measured: Baseline and Week 16
Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
Measured: Baseline and Week 16
Number of Treatment-Emergent Adverse Events (AEs)
Measured: From baseline to Week 16
Number of Treatment-Emergent AEs
Measured: From Week 16 to Week 54
Area Under the Curve (AUC 0-12)
Measured: Day 1 and Day 8 post-dose
Maximum Serum Concentration (Cmax)
Measured: Day 1 and Day 8 (0-12 hours post-dose)
Time to Peak Drug Concentration (Tmax)
Measured: Day 1 and Day 8 (0-12 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start5 Sep 2023
- Primary completion16 Dec 2024
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 362 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
- NCT06004050
- Sponsor's protocol ID
- LP0133-2283
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema
- ClinicalTrials.gov ID
- NCT06004050
- Acronym / sponsor ID
- LP0133-2283
- Conditions
- Chronic Hand Eczema
- Keywords
- Dermatologic Disease, Dermatology, Eczema, Chronic Hand Eczema, Delgocitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 22 Aug 2023 (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.
The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).
Detailed description
The trial comprises of a 16-week double-blind, treatment period, followed by an open label treatment period of 36 weeks. In the double-blind treatment period two thirds of participants will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle. In the double-blind treatment period, participants will use delgocitinib twice a day. In the open label period, participants will only use delgocitinib when needed (if their CHE flares up). Some participants will also give blood samples at the start of the trial for pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-Blind Period: Twice-Daily Delgocitinib Cream | Experimental | Drug: Delgocitinib20 mg/g twice daily |
| Double-Blind Period: Twice-Daily Vehicle Cream | Placebo comparator | Other: Vehicle cream20 mg/g twice daily |
| Open Label Period: Twice-Daily Delgocitinib | Experimental | Drug: Delgocitinib20 mg/g twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or above at screening for adult participants and age 12-17 years at screening and baseline for adolescent participants.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
- HESD itch score (weekly average) of ≥4 points at baseline. The baseline weekly average will be calculated from daily assessments of itch severity during the 7 days immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 itch scores out of the 7 days is required to calculate the baseline average score.
- Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Key exclusion criteria (39 listed)
- Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
- Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
- Clinically significant infection (e.g. impetiginized hand eczema) on the hands.
- Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the investigational medicinal product (IMP), or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
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 |
|---|---|---|
| DelgocitinibTopical administration | Drug | Double-Blind Period: Twice-Daily Delgocitinib Cream, Open Label Period: Twice-Daily Delgocitinib |
| Vehicle creamTopical administration | Other | Double-Blind Period: Twice-Daily Vehicle Cream |
Primary outcome
Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
Time frame: Week 16
The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.
18 secondary outcomes
Hand Eczema Severity Index (HECSI)-90 at Week 16
Time frame: Week 16
HECSI-75 at Week 16
Time frame: Week 16
Percentage Change in HECSI Score From Baseline to Week 16
Time frame: Baseline and Week 16
Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Participants With Reduction of HESD Pain Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in HESD Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in HESD Itch Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in HESD Pain Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in Hand Eczema Impact Scale (HEIS) Score
Time frame: Baseline and Week 16
Change in HEIS Proximal Daily Activity Limitations (PDAL) Score
Time frame: Baseline and Week 16
Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline to Week 16
Number of Treatment-Emergent AEs
Time frame: From Week 16 to Week 54
Area Under the Curve (AUC 0-12)
Time frame: Day 1 and Day 8 post-dose
Maximum Serum Concentration (Cmax)
Time frame: Day 1 and Day 8 (0-12 hours post-dose)
Time to Peak Drug Concentration (Tmax)
Time frame: Day 1 and Day 8 (0-12 hours post-dose)
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 25 Sep 2025.
- 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
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 37 sites in China.
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 8 inclusion and 39 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16 (time frame: Week 16). 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 25 Sep 2025.