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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

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).

Condition or disease Intervention/treatment Phase
Discoid Lupus Erythematosus Drug: Delgocitinib cream Drug: Delgocitinib cream vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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
Official Title: Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Delgocitinib cream 20 mg/g
Delgocitinib cream applied twice daily for 6 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 6 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. 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.


Secondary Outcome Measures :
  1. Number of adverse events (AEs) up to Week 6. [ Time Frame: Week 0 to Week 6 ]
    (Number of AEs per subject)

  2. Number of subjects with AEs up to Week 6. [ Time Frame: Week 0 to Week 6 ]
    (Subjects with 1 or more AEs)

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03958955


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, California
LEO Pharma Investigational Site Not yet recruiting
San Diego, California, United States, 92103
United States, Illinois
LEO Pharma Investigational Site Not yet recruiting
Skokie, Illinois, United States, 60077
United States, Massachusetts
LEO Pharma Investigational Site Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, New York
LEO Pharma Investigational Site Not yet recruiting
Forest Hills, New York, United States, 11375
United States, Ohio
LEO Pharma Investigational Site Not yet recruiting
Cincinnati, Ohio, United States, 45219
Denmark
LEO Pharma Inve Not yet recruiting
Hellerup, Denmark, 2900
LEO Pharma Investigational Site Recruiting
Odense, Denmark, 5000
France
LEO Pharma Investigational Site Not yet recruiting
Loiré, France, 42000
LEO Pharma Investigational Site Not yet recruiting
Nice, France, 06202
LEO Pharma Investigational Site Not yet recruiting
Paris, France, 75010
LEO Pharma Investigational Site Not yet recruiting
Toulouse, France, 31000
Germany
LEO Pharma Investigational Site Not yet recruiting
Aachen, Germany, 52074
LEO Pharma Investigational Site Not yet recruiting
Berlin, Germany, 10117
LEO Pharma Investigational Site Not yet recruiting
Bochum, Germany, 44791
LEO Pharma Investigational Site Recruiting
Dresden, Germany, 01307
LEO Pharma Investigational Site Not yet recruiting
Duesseldorf, Germany, 40225
LEO Pharma Investigational Site Recruiting
Erlangen, Germany, 91054
LEO Pharma Investigational Site Not yet recruiting
Oldenburg, Germany, 26133
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: NCT03958955     History of Changes
Other Study ID Numbers: EXP-1373
2018-003615-22 ( EudraCT Number )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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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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Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases