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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 : Completed
First Posted : September 25, 2018
Last Update Posted : October 14, 2020
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)
Actual Enrollment : 258 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
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : April 20, 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 treatment success) 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 treatment success. [ Time Frame: Week 0 to Week 16. ]
    Time to IGA treatment success response is defined as the time from baseline to first assessment of an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement.



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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 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.
  • 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.

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


Locations
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United States, Arizona
Leo Pharma Investigational Site
Tucson, Arizona, United States, 85724
United States, Florida
Leo Pharma Investigational Site
Hialeah, Florida, United States, 33012
United States, Oregon
Leo Pharma Investigational Site
Portland, Oregon, United States, 97223
Leo Pharma Investigational Site
Portland, Oregon, United States, 97239-4501
Denmark
Leo Pharma Investigational Site
Aarhus, Denmark, 8200
Leo Pharma Investigational Site
Copenhagen, Denmark, 2400
Leo Pharma Investigational Site
Hellerup, Denmark, 2900
LEO Pharma Investigational Site
Herlev, Denmark, 2730
Germany
Leo Pharma Investigational Site
Berlin, Germany, 10117
Leo Pharma Investigational Site
Bochum, Germany, 44791
Leo Pharma Investigational Site
Bremerhaven, Germany, 27574
Leo Pharma Investigational Site
Dresden, Germany, 01307
Leo Pharma Investigational Site
Düsseldorf, Germany, 40225
Leo Pharma Investigational Site
Gera, Germany, 07548
Leo Pharma Investigational Site
Göttingen, Germany, 37075
Leo Pharma Investigational Site
Jena, Germany, 07743
Leo Pharma Investigational Site
Kiel, Germany, 24105
Leo Pharma Investigational Site
Kiel, Germany, 24148
Leo Pharma Investigational Site
Langenau, Germany, 89129
Leo Pharma Investigational Site
Lübeck, Germany, 23538
Leo Pharma Investigational Site
Mahlow, Germany, 15831
Leo Pharma Investigational Site
Mainz, Germany, 55101
Leo Pharma Investigational Site
Memmingen, Germany, 87700
Leo Pharma Investigational Site
München, Germany, 80337
Leo Pharma Investigational Site
Selters, Germany, 56242
Leo Pharma Investigational Site
Stuttgart, Germany, 70178
Leo Pharma Investigational Site
Stuttgart, Germany, 70499
Leo Pharma Investigational Site
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    
Other Study ID Numbers: LP0133-1273
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: https://www.leopharmatrials.com/For-professionals

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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