Chronic Hand EczemaPhase 3DELTA 3NCT04949841
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
A Phase 3 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 95 sites in 10 countries.
Trial summary
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib. Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 95 sitesin 10 countries
- Study dates
- 23 Aug 2021to 18 Sep 2023
- Phase
- Phase 3
- 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
- Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
- Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
- Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.
Who cannot join
- Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
- Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
- Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.
Trial locations and contacts
95 sites in 10 countries.
95 sites in 10 countries
Germany20 sites
LEO Investigational Site
Aachen, 52074
LEO Investigational Site
Bad Bentheim, 48455
LEO Investigational Site
Berlin, 10115
LEO Investigational Site
Bretzenheim, 55128
LEO Investigational Site
Dresden, 01307
LEO Investigational Site
Frankfurt am Main, 60590
LEO Investigational Site
Friedrichshafen, 88045
LEO Investigational Site
Gera, 07548
LEO Investigational Site
Göttingen, 37073
LEO Investigational Site
Hamburg, 22391
LEO Investigational Site
Hanover, 30159
LEO Investigational Site
Haßfurt, 97437
LEO Investigational Site
Jena, 07743
LEO Investigational Site
Lübeck, 23538
LEO Investigational Site
Mahlow, 15831
LEO Pharma Investigational Site
Memmingen, 87700
LEO Investigational Site
München, 80802
Leo Investigational Site
Münster, 48149
LEO Investigational Site
Osnabrück, 49074
LEO Investigational Site
Stuttgart, 70178
Canada19 sites
LEO Investigational Site
Ajax, Ontario, L1S 7K8
LEO Investigational Site
Calgary, Alberta, T2J 7E1
LEO Investigational Site
Calgary, Alberta, T3E 0B2
LEO Investigational Site
Cobourg, Ontario, K9A 4J9
LEO Investigational Site
Edmonton, Alberta, T5J 3S9
LEO Investigational Site
Edmonton, Alberta, T6G 1C3
LEO Investigational Site
Etobicoke, Ontario, M8X 1Y9
LEO Investigational Site
Fredericton, New Bruswick, E3B 1G9
LEO Investigational Site
Hamilton, Ontario, L8S 1G5
LEO Investigational Site
Kingston, Ontario, K7L 2V7
LEO Investigational Site
London, Ontario, N6A 3H7
LEO Investigational Site
Markham, Ontario, L3P 1X3
LEO Investigational Site
Montreal, Quebec, H2X 2V1
LEO Investigational Site
Surrey, British Columbia, V3R 6A7
LEO Investigational Site
Toronto, Ontario, M2M 4J5
LEO Investigational Site
Toronto, Ontario, M3H 5Y8
LEO Investigational Site
Vancouver, British Columbia, V6 4E1
LEO Investigational Site
Waterloo, Ontario, N2J 1C4
LEO Investigational Site
Windsor, Ontario, N8W 1E6
Poland16 sites
LEO Investigitional Site
Bialystok, 15-375
LEO Investigational Site
Bialystok, 15-794
LEO Investigational Site
Gdansk, 80-546
LEO Investigational Site
Krakow, 30-033
LEO Investigational Site
Krakow, 31-011
LEO Investigational Site
Lodz, 90-436
LEO Investigational Site
Lublin, 20-081
LEO Investigational Site
Lublin, 20-406
LEO Investigational Site
Osielsko, 86-031
LEO Pharma Investigational Site
Rzeszów, 35-055
LEO Investigational Site
Warsaw, 02-507
LEO Investigational Site
Warsaw, 02-625
LEO Investigational Site
Warsaw, 02-953
LEO Investigational Site
Warsaw, 02-962
LEO Investigational Site
Wroclaw, 50-566
LEO Investigational Site
Wroclaw, 51-318
France11 sites
LEO Investigational Site
Bordeaux, 33000
LEO Investigational Site
Dijon, 21000
LEO Investigational Site
Le Mans, 72037
LEO Investigational Site
Lille, 5900
LEO Investigational Site
Martigues, 13500
LEO Pharma Investigational Site
Nantes, 44093
LEO Investigational Site
Nice, 06000
LEO Investigational Site
Nice, 06202
LEO Investigational Site
Paris, 75014
LEO Investigational Site
Reims, 51100
LEO Investigational Site
Toulouse, 31000
Spain7 sites
LEO Investigational Site
Alicante, 03010
LEO Investigational Site
Badalona, 08915
LEO Investigitional Site
Barcelona, 08041
LEO Investigational Site
Bilbao, 48013
LEO Investigational Site
Madrid, 28031
LEO Investigational Site
Mieres, 33611
LEO Investigational Site
Seville, 41009
Belgium6 sites
LEO Investigational Site
Brussels, 1000
LEO Investigational Site
Ghent, 9000
LEO Investigational Site
Kortrijk, 8500
LEO Investigational Site
Leuven, 3000
LEO Investigational Site
Loverval, 6280
LEO Investigational Site
Maldegem, 9990
Netherlands5 sites
LEO Investigational Site
Amsterdam, 1105 AZ
LEO Investigational Site
Bergen op Zoom, 4614 VT
LEO Investigational Site
Groningen, 9713 GZ
LEO Investigational Site
Hoofddorp, 2134 TM
LEO Investigational Site
Utrecht, 3584 CX
Italy4 sites
LEO Investigational Site
Brescia, 25123
LEO Investigational Site
L’Aquila, 67100
LEO Investigational Site
Rome, 00168
LEO Investigational Site
Vicenza, 36100
United Kingdom4 sites
LEO Investigational Site
London, SE1 7EH
LEO Investigational Site
Middlesbrough, TS4 3BW
LEO Investigational Sites
Redhill, Surrey, RH1 5RH
LEO Investigational Site
Salford, M6 8HD
Denmark3 sites
LEO Investigational Site
Aarhus N, 8200
LEO investigational Site
Copenhagen, 2400
LEO Pharma Investigational Site
Hellerup, 2900
About this study
Official title: A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.
Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.
Read the detailed description
Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.
Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.
Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).
- Conditions
- Chronic Hand Eczema
- Being tested
- Delgocitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Delgocitinib cream 20 mg/g
| Study group | Role | What they receive |
|---|---|---|
| As-needed treatment with delgocitinib | Experimental | Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. Receives: Drug: Delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events From Baseline up to Week 38
An AE will be considered treatment emergent if it started after the baseline visit
Measured: From baseline up to Week 38
Secondary outcomes (5)
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: From baseline up to Week 38
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: From baseline up to Week 38
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
Measured: From baseline up to Week 38
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.
Measured: From baseline up to Week 38
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.
Measured: From baseline up to Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start23 Aug 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
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 (1)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 801 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
- NCT04949841
- Sponsor's protocol ID
- LP0133-1403
- Other IDs
- 2020-002962-15, U1111-1284-2216
- Acronym
- DELTA 3
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2021
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gooderham M, Molin S, Bissonnette R, Worm M, Crepy MN, Stingeni L, Warren RB, Schliemann S, Schuttelaar ML, Ferrucci S, Serra-Baldrich E, Silverberg JI, Balita-Crisostomo CL, Osterdal ML, Plohberger U, Agner T. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. J Am Acad Dermatol. 2025 Jul;93(1):95-103. doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11.
PubMed 40081663
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)
- ClinicalTrials.gov ID
- NCT04949841
- Acronym / sponsor ID
- DELTA 3 / LP0133-1403
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 20 Jan 2025
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 extension trial is to evaluate the long-term safety of delgocitinib.
Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.
Detailed description
Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.
Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.
Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| As-needed treatment with delgocitinib | Experimental | Drug: DelgocitinibSubjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
- Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
- Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.
Key exclusion criteria (3 listed)
- Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
- Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
- Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.
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 |
|---|---|---|
| DelgocitinibDelgocitinib cream 20 mg/g | Drug | As-needed treatment with delgocitinib |
Primary outcome
Number of Treatment-emergent Adverse Events From Baseline up to Week 38
Time frame: From baseline up to Week 38
An AE will be considered treatment emergent if it started after the baseline visit
5 secondary outcomes
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Time frame: From baseline up to Week 38
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Time frame: From baseline up to Week 38
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Time frame: From baseline up to Week 38
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Time frame: From baseline up to Week 38
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Time frame: From baseline up to Week 38
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40081663Gooderham M, Molin S, Bissonnette R, Worm M, Crepy MN, Stingeni L, Warren RB, Schliemann S, Schuttelaar ML, Ferrucci S, Serra-Baldrich E, Silverberg JI, Balita-Crisostomo CL, Osterdal ML, Plohberger U, Agner T. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. J Am Acad Dermatol. 2025 Jul;93(1):95-103. doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11.
- 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
95 sites in 10 countries: 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 95 sites in 10 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 4 inclusion and 3 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Germany, Canada, Poland, France, Spain and 5 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. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2025). 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?
Number of Treatment-emergent Adverse Events From Baseline up to Week 38 (time frame: From baseline up to Week 38). 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 NCT04949841, 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 8 Apr 2025.