Discoid lupus erythematosus MedDRA version: 21.1 Level: LLT Classification code 10013072 Term: Discoid lupus erythematosus System Organ Class: 100000004858
Conditions
Interventions
Product Name: Delgocitinib cream
Product Code: LEO 124249
Pharmaceutical Form: Cream
INN or Proposed INN: Delgocitinib
CAS Number: 1263774-59-9
Current Sponsor code: LEO 124249
Other descriptive name
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-70 years. • Histopathological findings (current or previous) consistent with clinical diagnosis of DLE. • Unequivocal clinical diagnosis of 2 active DLE target lesions that are =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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. 6-9) including LE-related pleuritis or pericarditis (by clinical evaluation, i.e. no electrocardiogram or X-ray required), 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. • Unstable or fluctuating use of tobacco within 1 month prior to screening which, in the opinion of the investigator, may 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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of delgocitinib cream 20 mg/g twice daily on active DLE target lesions.;Secondary Objective: To evaluate the safety of delgocitinib cream 20 mg/g twice daily on active DLE target lesions To further investigate the efficacy of delgocitinib cream 20 mg/g twice daily on active DLE target lesions;Primary end point(s): • Target lesions with Investigator’s Global Assessment (IGA) score of 0 or 1 at Week 6.;Timepoint(s) of evaluation of this end point: At week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of adverse events (AEs) up to Week 6 • Number of subjects with AEs up to Week 6 • Number of lesion-specific, treatment-related AEs up to Week 6. • A =2-point reduction in IGA score at Week 6 compared to baseline. • A =2-point reduction in erythema score at Week 6 compared to baseline. • Erythema score at Week 6. • Total skin disease activity score (sum of scores for erythema, scaling/hyperkeratosis, and oedema/infiltration at Week 6. ;Timepoint(s) of evaluation of this end point: Week 6 | — |
Countries
Denmark, France, Germany, United States
Contacts
Public ContactBente Tholstrup
LEO Pharma A/S
Outcome results
None listed