Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.

LEO Pharma2 sites in 2 countries27 target enrollmentJuly 9, 2019

ConditionsDiscoid Lupus Erythematosus

InterventionsDelgocitinib cream Delgocitinib cream vehicle

DrugsDelgocitinib cream Delgocitinib cream vehicle

Overview

Phase: Phase 2
Intervention: Delgocitinib cream
Conditions: Discoid Lupus Erythematosus
Sponsor: LEO Pharma
Enrollment: 27
Locations: 2
Primary Endpoint: Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 9, 2019

End Date

April 30, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

Delgocitinib cream 20 mg/g

Delgocitinib cream applied twice daily for 6 weeks

Intervention: Delgocitinib cream

Delgocitinib cream vehicle

Delgocitinib cream vehicle applied twice daily for 6 weeks

Intervention: Delgocitinib cream vehicle

Outcomes

Primary Outcomes

Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.

Time Frame: 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 Outcomes

Number of Subjects With AEs up to Week 6.(Week 0 to Week 6)
Number of Lesion-specific, Treatment-related AEs up to Week 6.(Week 0 to Week 6)
Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.(Week 6)
Number of Adverse Events (AEs) up to Week 6.(Week 0 to Week 6)
Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.(Week 0 to Week 6)
Erythema Score at Week 6.(Week 6)
Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.(Week 0 to Week 6)