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Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

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ClinicalTrials.gov Identifier: NCT03958955
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Target lesions with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 6. [ Time Frame: Week 0 to Week 6 ]
The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA is a lesion-specific assessment and will be evaluated separately for each of the 2 target lesions.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03958955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Number of adverse events (AEs) up to Week 6. [ Time Frame: Week 0 to Week 6 ]
    (Number of AEs per subject)
  • Number of subjects with AEs up to Week 6. [ Time Frame: Week 0 to Week 6 ]
    (Subjects with 1 or more AEs)
  • Number of lesion-specific, treatment-related AEs up to Week 6. [ Time Frame: Week 0 to Week 6 ]
    The number of lesion-specific, treatment-related AEs per target lesion will be compared for active and vehicle treatment. Lesion-specific AEs are defined as lesional/perilesional AEs (i.e. AE location within the treatment area and/or ≤2 cm from the border of a target lesion).
  • A ≥2-point reduction in IGA score at Week 6 compared to baseline. [ Time Frame: Week 0 to Week 6 ]
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA is a lesion-specific assessment and will be evaluated separately for each of the 2 target lesions.
  • A ≥2-point reduction in erythema score at Week 6 compared to baseline. [ Time Frame: Week 0 to week 6 ]
    The erythema score is lesion-specific and based on the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and the Revised CLASI (RCLASI) which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic.
  • Erythema score at Week 6. [ Time Frame: Week 0 to Week 6 ]
    The erythema score is lesion-specific and based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic.
  • Total skin disease activity score (sum of scores for erythema, scaling/hyperkeratosis, and oedema/infiltration) at Week 6. [ Time Frame: Week 0 to Week 6 ]
    The disease activity scores are based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The total skin disease activity score is defined as the sum of the scores for 3 clinical signs (erythema, scaling/hyperkeratosis, oedema/infiltration) for each target lesion. For the total score and the individual clinical signs, higher scores indicate more severe symptoms. Erythema is scored on a 4-point scale ranging from 0 (absent) to 3 (dark red, purple/violaceous/crusted/haemorrhagic). Hyperkeratosis/scaling is scored on a 3-point scale from 0 (absent) to 2 (verrucous hyperkeratosis). Oedema/infiltration is scored on a 3-point scale from 0 (absent) to 2 (palpable and visible). The total skin disease activity score can therefore range from 0 to 7.
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 Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.
Official Title  ICMJE Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.
Brief Summary This is a double-blind, multi-centre, randomised, vehicle-controlled, within-subject trial. The trial is designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a within-subject trial design, where all subjects will be treated with active treatment on one DLE target lesion and vehicle treatment on another DLE target lesion.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Discoid Lupus Erythematosus
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 20 mg/g
    Delgocitinib cream applied twice daily for 6 weeks
    Intervention: Drug: Delgocitinib cream
  • Placebo Comparator: Delgocitinib cream vehicle
    Delgocitinib cream vehicle applied twice daily for 6 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: May 20, 2019)
45
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

Main Inclusion Criteria:

  • Histopathological findings (current or previous) consistent with clinical diagnosis of DLE.
  • Unequivocal clinical diagnosis of 2 active DLE target lesions that are <6 months old and amenable for clinical evaluation. This includes lesions located on the scalp if they fulfil all lesion-specific eligibility criteria.
  • Target lesion IGA score of at least moderate severity (≥3) at screening and baseline.
  • Target lesion erythema score ≥2 at screening and baseline.

Main Exclusion Criteria:

  • Target lesion dyspigmentation score of 2 at screening or baseline.
  • Target lesion scarring/atrophy score of 2 at screening or baseline.
  • Target lesion scarring alopecia score of >0 in scalp lesions at screening or baseline.
  • Medical history of systemic lupus erythematosus (SLE) with clinically significant organ involvement (American College of Rheumatology SLE classification criteria no. 6 to 9) including SLE-related pleuritis or pericarditis (by clinical evaluation and electrocardiogram), and neurologic, renal, and/or other major SLE-related organ system involvement. SLE joint involvement is acceptable.
  • Subjects with unstable or significant SLE disease activity findings that would, by its progressive nature and/or severity, interfere with the trial evaluation, completion, and/or procedures per the investigator's discretion.
  • Other skin conditions at screening or baseline that would interfere with the evaluation of DLE.
  • Immunosuppressive/immunomodulating therapy with e.g. methotrexate, cyclosporine, azathioprine, retinoids (both topical and systemic), or dapsone within 4 weeks prior to baseline.
  • Systemic prednisolone >7.5 mg/day or changed dose within 4 weeks prior to baseline (nasal and inhaled corticosteroids are allowed).
  • Treatment with the following medications:

    • Oral antimalarial treatment with hydroxychloroquine >6.5 mg/kg body weight/day, or chloroquine >4 mg/kg body weight/day, or changed dose within 12 weeks prior to baseline.
    • Quinacrine combined with either hydroxychloroquine or chloroquine within 12 weeks prior to baseline.
    • Drugs known to interact with antimalarials (e.g. digoxin, cimetidine) within 12 weeks prior to baseline.
  • Treatment with topical corticosteroids, calcineurin inhibitors, and phosphodiesterase-4 (PDE-4) inhibitors within 2 weeks prior to baseline.
  • Use of systemic antibiotics or cutaneously applied antibiotics on the target lesions within 2 weeks prior to baseline.
  • Ultraviolet (UV) therapy within 2 weeks prior to baseline.
  • Any procedure impairing the skin barrier (e.g. incision) within 2 cm from the border of any of the target lesions within 4 weeks prior to baseline.
  • Receipt of live (attenuated) vaccines within 4 weeks prior to baseline.
  • Treatment with any marketed biological therapy or investigational biologic agents:

    • Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
    • Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
  • Smoking of >70 cigarettes/week or >70 g of tobacco content/week within 1 month prior to screening.
  • History of any active skin infection within 1 week prior to baseline.
  • Clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:

    • A systemic infection.
    • A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
  • Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening. Subjects with high risk of latent tuberculosis (e.g. prior residence in or travel to countries with high prevalence of tuberculosis, close contact with a person with active tuberculosis, or a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed) must be tested at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 Denmark,   France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958955
Other Study ID Numbers  ICMJE EXP-1373
2018-003615-22 ( EudraCT Number )
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
Plan Description:

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

Data sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data is available to request after approval of the studied indication.
URL: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx
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 June 2019

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