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Trial record 4 of 154 for:    Dermatitis, Atopic, 8

Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.

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ClinicalTrials.gov Identifier: NCT03725722
Recruitment Status : Recruiting
First Posted : October 31, 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 investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis 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 Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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 8 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 8 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 8 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 8 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 8 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. Change from baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) score. [ Time Frame: Week 0 to Week 8 ]
    EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.


Secondary Outcome Measures :
  1. Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with ≥2-step improvement (vIGA-AD 0/1) from baseline to Week 8. [ Time Frame: Week 0 to Week 8 ]
    vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)

  2. EASI75 at Week 8 [ Time Frame: Week 0 to Week 8 ]
    EASI75 is defined as at least 75% reduction in EASI from baseline.

  3. Time to vIGA-AD 0/1 [ Time Frame: Week 0 to Week 8 ]
    The time to vIGA-AD 0/1 response is defined as the time from baseline to first assessment of a vIGA-AD 0/1



Information from the National Library of Medicine

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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 and above.
  • Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
  • History of AD for ≥1 year.
  • AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
  • Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

  • AD lesion(s) on scalp at screening and/or baseline.
  • Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
  • Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
  • Use of tanning beds or phototherapy within 4 weeks prior to baseline.
  • Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
  • Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
  • Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
  • Receipt of live attenuated vaccines within 4 weeks prior to baseline.
  • Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
  • History of any active skin infection within 1 week prior to baseline.
  • Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.

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): NCT03725722


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

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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: NCT03725722     History of Changes
Other Study ID Numbers: LP0133-1275
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: January 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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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases