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Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

Primary Purpose

Discoid Lupus Erythematosus

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Delgocitinib cream
Delgocitinib cream vehicle
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoid Lupus Erythematosus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Histopathological findings (current or previous) consistent with clinical diagnosis of DLE.
  • Unequivocal clinical diagnosis of 2 active DLE target lesions that were <6 months old and amenable for clinical evaluation. This included lesions located on the scalp if they fulfilled 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 was 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 were 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 returned to normal, whichever was longer.
    • Other biologics: within 3 months or 5 half-lives, whichever was longer, prior to baseline.
  • Unstable or fluctuating use of tobacco within 1 month prior to screening which, in the opinion of the investigator, could affect the natural course of the disease and thus affect the evaluation of the treatment.
  • 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, could 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 have been tested at screening.

Sites / Locations

  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Delgocitinib cream 20 mg/g

Delgocitinib cream vehicle

Arm Description

Delgocitinib cream applied twice daily for 6 weeks

Delgocitinib cream vehicle applied twice daily for 6 weeks

Outcomes

Primary Outcome Measures

Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at 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 was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.

Secondary Outcome Measures

Number of Adverse Events (AEs) up to Week 6.
Number of AEs from baseline to Week 6
Number of Subjects With AEs up to Week 6.
Number of subjects with AEs from baseline to Week 6
Number of Lesion-specific, Treatment-related AEs up 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).
Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.
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 was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.
Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.
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.
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.
The skin 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.

Full Information

First Posted
May 20, 2019
Last Updated
June 4, 2021
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03958955
Brief Title
Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to recruitment challenges.
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This was a phase 2a, within-subject trial design, where all subjects were treated with active treatment on one DLE target lesion and vehicle treatment on another DLE target lesion.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delgocitinib cream 20 mg/g
Arm Type
Experimental
Arm Description
Delgocitinib cream applied twice daily for 6 weeks
Arm Title
Delgocitinib cream vehicle
Arm Type
Placebo Comparator
Arm Description
Delgocitinib cream vehicle applied twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream
Other Intervention Name(s)
LEO 124249 cream
Intervention Description
Cream for topical application.
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream vehicle
Other Intervention Name(s)
LEO 124249 cream vehicle
Intervention Description
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Primary Outcome Measure Information:
Title
Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.
Description
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 was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Number of Adverse Events (AEs) up to Week 6.
Description
Number of AEs from baseline to Week 6
Time Frame
Week 0 to Week 6
Title
Number of Subjects With AEs up to Week 6.
Description
Number of subjects with AEs from baseline to Week 6
Time Frame
Week 0 to Week 6
Title
Number of Lesion-specific, Treatment-related AEs up to Week 6.
Description
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).
Time Frame
Week 0 to Week 6
Title
Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.
Description
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 was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.
Time Frame
Week 0 to Week 6
Title
Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.
Description
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.
Time Frame
Week 0 to Week 6
Title
Erythema Score at Week 6.
Description
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.
Time Frame
Week 6
Title
Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.
Description
The skin 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.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 were <6 months old and amenable for clinical evaluation. This included lesions located on the scalp if they fulfilled 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 was 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 were 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 returned to normal, whichever was longer. Other biologics: within 3 months or 5 half-lives, whichever was longer, prior to baseline. Unstable or fluctuating use of tobacco within 1 month prior to screening which, in the opinion of the investigator, could affect the natural course of the disease and thus affect the evaluation of the treatment. 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, could 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 have been tested at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
LEO Pharma Investigational site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
LEO Pharma Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
LEO Pharma Investigational Site
City
Loiré
ZIP/Postal Code
42000
Country
France
Facility Name
LEO Pharma Investigational Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
LEO Pharma Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
LEO Pharma Investigational Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
LEO Pharma Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data (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.
IPD Sharing Time Frame
Data is available to request after approval of the studied indication.
IPD Sharing URL
https://www.leopharmatrials.com/en/for-professionals
Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

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