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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

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE December 28, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03725722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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)
  • EASI75 at Week 8 [ Time Frame: Week 0 to Week 8 ]
    EASI75 is defined as at least 75% reduction in EASI from baseline.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Delgocitinib cream
    Cream for topical application
    Other Name: LEO 124249 cream
  • 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
Study Arms  ICMJE
  • Experimental: Delgocitinib cream 1 mg/g
    Delgocitinib cream applied twice daily for 8 weeks
    Intervention: Drug: Delgocitinib cream
  • Experimental: Delgocitinib cream 3 mg/g
    Delgocitinib cream applied twice daily for 8 weeks
    Intervention: Drug: Delgocitinib cream
  • Experimental: Delgocitinib cream 8 mg/g
    Delgocitinib cream applied twice daily for 8 weeks
    Intervention: Drug: Delgocitinib cream
  • Experimental: Delgocitinib cream 20 mg/g
    Delgocitinib cream applied twice daily for 8 weeks
    Intervention: Drug: Delgocitinib cream
  • Placebo Comparator: Delgocitinib cream vehicle
    Delgocitinib cream vehicle applied twice daily for 8 weeks
    Intervention: Drug: Delgocitinib cream vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03725722
Other Study ID Numbers  ICMJE LP0133-1275
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert LEO Pharma
PRS Account LEO Pharma
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP