Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
NCT ID: NCT04949841
Last Updated: 2025-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
801 participants
INTERVENTIONAL
2021-08-23
2023-09-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)
NCT04872101
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
NCT05355818
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
NCT04871711
Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema
NCT05486117
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
NCT03826901
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
As-needed treatment with delgocitinib
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.
Delgocitinib
Delgocitinib cream 20 mg/g
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Delgocitinib
Delgocitinib cream 20 mg/g
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LEO Investigational Site
Brussels, , Belgium
LEO Investigational Site
Ghent, , Belgium
LEO Investigational Site
Kortrijk, , Belgium
LEO Investigational Site
Leuven, , Belgium
LEO Investigational Site
Loverval, , Belgium
LEO Investigational Site
Maldegem, , Belgium
LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
LEO Investigational Site
Surrey, British Columbia, Canada
LEO Investigational Site
Vancouver, British Columbia, Canada
LEO Investigational Site
Fredericton, New Bruswick, Canada
LEO Investigational Site
Ajax, Ontario, Canada
LEO Investigational Site
Cobourg, Ontario, Canada
LEO Investigational Site
Etobicoke, Ontario, Canada
LEO Investigational Site
Hamilton, Ontario, Canada
LEO Investigational Site
Kingston, Ontario, Canada
LEO Investigational Site
London, Ontario, Canada
LEO Investigational Site
Markham, Ontario, Canada
LEO Investigational Site
Toronto, Ontario, Canada
LEO Investigational Site
Toronto, Ontario, Canada
LEO Investigational Site
Waterloo, Ontario, Canada
LEO Investigational Site
Windsor, Ontario, Canada
LEO Investigational Site
Montreal, Quebec, Canada
LEO Investigational Site
Aarhus N, , Denmark
LEO investigational Site
Copenhagen, , Denmark
LEO Pharma Investigational Site
Hellerup, , Denmark
LEO Investigational Site
Bordeaux, , France
LEO Investigational Site
Dijon, , France
LEO Investigational Site
Le Mans, , France
LEO Investigational Site
Lille, , France
LEO Investigational Site
Martigues, , France
LEO Pharma Investigational Site
Nantes, , France
LEO Investigational Site
Nice, , France
LEO Investigational Site
Nice, , France
LEO Investigational Site
Paris, , France
LEO Investigational Site
Reims, , France
LEO Investigational Site
Toulouse, , France
LEO Investigational Site
Aachen, , Germany
LEO Investigational Site
Bad Bentheim, , Germany
LEO Investigational Site
Berlin, , Germany
LEO Investigational Site
Bretzenheim, , Germany
LEO Investigational Site
Dresden, , Germany
LEO Investigational Site
Frankfurt am Main, , Germany
LEO Investigational Site
Friedrichshafen, , Germany
LEO Investigational Site
Gera, , Germany
LEO Investigational Site
Göttingen, , Germany
LEO Investigational Site
Hamburg, , Germany
LEO Investigational Site
Hanover, , Germany
LEO Investigational Site
Haßfurt, , Germany
LEO Investigational Site
Jena, , Germany
LEO Investigational Site
Lübeck, , Germany
LEO Investigational Site
Mahlow, , Germany
LEO Pharma Investigational Site
Memmingen, , Germany
LEO Investigational Site
München, , Germany
Leo Investigational Site
Münster, , Germany
LEO Investigational Site
Osnabrück, , Germany
LEO Investigational Site
Stuttgart, , Germany
LEO Investigational Site
Brescia, , Italy
LEO Investigational Site
L’Aquila, , Italy
LEO Investigational Site
Rome, , Italy
LEO Investigational Site
Vicenza, , Italy
LEO Investigational Site
Amsterdam, , Netherlands
LEO Investigational Site
Bergen op Zoom, , Netherlands
LEO Investigational Site
Groningen, , Netherlands
LEO Investigational Site
Hoofddorp, , Netherlands
LEO Investigational Site
Utrecht, , Netherlands
LEO Investigitional Site
Bialystok, , Poland
LEO Investigational Site
Bialystok, , Poland
LEO Investigational Site
Gdansk, , Poland
LEO Investigational Site
Krakow, , Poland
LEO Investigational Site
Krakow, , Poland
LEO Investigational Site
Lodz, , Poland
LEO Investigational Site
Lublin, , Poland
LEO Investigational Site
Lublin, , Poland
LEO Investigational Site
Osielsko, , Poland
LEO Pharma Investigational Site
Rzeszów, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Wroclaw, , Poland
LEO Investigational Site
Wroclaw, , Poland
LEO Investigational Site
Alicante, , Spain
LEO Investigational Site
Badalona, , Spain
LEO Investigitional Site
Barcelona, , Spain
LEO Investigational Site
Bilbao, , Spain
LEO Investigational Site
Madrid, , Spain
LEO Investigational Site
Mieres, , Spain
LEO Investigational Site
Seville, , Spain
LEO Investigational Sites
Redhill, Surrey, United Kingdom
LEO Investigational Site
London, , United Kingdom
LEO Investigational Site
Middlesbrough, , United Kingdom
LEO Investigational Site
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-002962-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1284-2216
Identifier Type: OTHER
Identifier Source: secondary_id
LP0133-1403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.