Efficacy and safety of twice-daily application of delgocitinib cream 20 mg/g for 6 weeks in subjects with active discoid lupus erythematosus.A phase 2a exploratory, randomised, double-blind, vehicle-controlled, within-subject, multi-centre trial.

EO Pharma A/S0 sites45 target enrollmentApril 26, 2019

ConditionsDiscoid lupus erythematosus MedDRA version: 20.0Level: LLTClassification code 10013072Term: Discoid lupus erythematosusSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Discoid lupus erythematosus
Sponsor: EO Pharma A/S
Enrollment: 45
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 26, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

EO Pharma A/S

Eligibility 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 \<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 Investigator Global Assessment score of at least moderate (\=3\) at screening and baseline.
•Target lesion erythema score \=2 at screening and baseline.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 40
•F.1\.3 Elderly (\>\=65 years) yes

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.