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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

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ClinicalTrials.gov Identifier: NCT03683719
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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 to investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe chronic hand eczema.

Condition or disease Intervention/treatment Phase
Chronic Hand Eczema Drug: Delgocitinib cream Drug: Delgocitinib cream vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Delgocitinib cream 1 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Drug: Delgocitinib cream
Cream for topical application.
Other Name: LEO 124249 cream

Experimental: Delgocitinib cream 3 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Drug: Delgocitinib cream
Cream for topical application.
Other Name: LEO 124249 cream

Experimental: Delgocitinib cream 8 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Drug: Delgocitinib cream
Cream for topical application.
Other Name: LEO 124249 cream

Experimental: Delgocitinib cream 20 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Drug: Delgocitinib cream
Cream for topical application.
Other Name: LEO 124249 cream

Placebo Comparator: Delgocitinib cream vehicle
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Drug: Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Other Name: LEO 124249 cream vehicle




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement (IGA 0/1) from baseline to Week 16. [ Time Frame: Week 0 to Week 16. ]
    IGA 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).


Secondary Outcome Measures :
  1. Change in Hand Eczema Severity Index (HECSI) from baseline to Week 16. [ Time Frame: Week 0 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).

  2. Time to IGA 0/1. [ Time Frame: Week 0 to Week 16. ]
    Time to IGA 0/1 response is defined as the time from baseline to first assessment of an IGA 0/1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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:

  • Concurrent skin diseases on the hands.
  • 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.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683719


Contacts
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Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

Locations
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United States, Arizona
Leo Pharma Investigational Site Not yet recruiting
Tucson, Arizona, United States, 85719
United States, Florida
Leo Pharma Investigational Site Recruiting
Hialeah, Florida, United States, 33012
United States, Minnesota
Leo Pharma Investigational Site Not yet recruiting
Minneapolis, Minnesota, United States, 55455-4800
United States, New York
Leo Pharma Investigational Site Not yet recruiting
Corning, New York, United States, 14830
United States, Oregon
Leo Pharma Investigational Site Recruiting
Portland, Oregon, United States, 97223
Leo Pharma Investigational Site Not yet recruiting
Portland, Oregon, United States, 97239-4501
Denmark
Leo Pharma Investigational Site Not yet recruiting
Aarhus, Denmark, 8200
Leo Pharma Investigational Site 1 Not yet recruiting
Hellerup, Denmark, 2900
Leo Pharma Investigational Site Not yet recruiting
Hellerup, Denmark, 2900
Leo Pharma Investigational Site Not yet recruiting
Roskilde, Denmark, 4000
Germany
Leo Pharma Investigational Site Not yet recruiting
Berlin, Germany, 10117
Leo Pharma Investigational Site Not yet recruiting
Bochum, Germany, 44791
Leo Pharma Investigational Site Not yet recruiting
Bremerhaven, Germany, 27574
Leo Pharma Investigational Site Not yet recruiting
Dresden, Germany, 01307
Leo Pharma Investigational Site Not yet recruiting
Düsseldorf, Germany, 40225
Leo Pharma Investigational Site Not yet recruiting
Gera, Germany, 07548
Leo Pharma Investigational Site Not yet recruiting
Göttingen, Germany, 37075
Leo Pharma Investigational Site Not yet recruiting
Hamburg, Germany, 20246
Leo Pharma Investigational Site Not yet recruiting
Jena, Germany, 07743
Leo Pharma Investigational Site Not yet recruiting
Kiel, Germany, 24105
Leo Pharma Investigational Site Not yet recruiting
Kiel, Germany, 24148
Leo Pharma Investigational Site Not yet recruiting
Langenau, Germany, 89129
Leo Pharma Investigational Site Not yet recruiting
Lübeck, Germany, 23538
Leo Pharma Investigational Site Not yet recruiting
Mahlow, Germany, 15831
Leo Pharma Investigational Site Not yet recruiting
Mainz, Germany, 55101
Leo Pharma Investigational Site Not yet recruiting
Markkleeberg, Germany, 04416
Leo Pharma Investigational Site Not yet recruiting
Memmingen, Germany, 87700
Leo Pharma Investigational Site Not yet recruiting
München, Germany, 80337
Leo Pharma Investigational Site Not yet recruiting
Selters, Germany, 56242
Leo Pharma Investigational Site Not yet recruiting
Stuttgart, Germany, 70178
Leo Pharma Investigational Site Not yet recruiting
Stuttgart, Germany, 70499
Leo Pharma Investigational Site Not yet recruiting
Wuppertal, Germany, 42287
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03683719     History of Changes
Other Study ID Numbers: LP0133-1273
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous