Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

NCT ID: NCT03958955

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2020-04-30

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).

Conditions

Discoid Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Delgocitinib cream 20 mg/g

Delgocitinib cream applied twice daily for 6 weeks

Group Type: EXPERIMENTAL

Delgocitinib cream

Intervention Type: DRUG

Cream for topical application.

Delgocitinib cream vehicle

Delgocitinib cream vehicle applied twice daily for 6 weeks

Group Type: PLACEBO_COMPARATOR

Delgocitinib cream vehicle

Intervention Type: DRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Interventions

Delgocitinib cream

Cream for topical application.

Intervention Type: DRUG

Delgocitinib cream vehicle

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Intervention Type: DRUG

Other Intervention Names

LEO 124249 cream; LEO 124249 cream vehicle

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma Investigational Site

San Diego, California, United States

LEO Pharma Investigational Site

Skokie, Illinois, United States

LEO Pharma Investigational Site

Boston, Massachusetts, United States

LEO Pharma Investigational Site

Forest Hills, New York, United States

LEO Pharma Investigational Site

Cincinnati, Ohio, United States

LEO Pharma Investigational Site

Aarhus, , Denmark

LEO Pharma Investigational site

Hellerup, , Denmark

LEO Pharma Investigational Site

Odense, , Denmark

LEO Pharma Investigational Site

Loiré, , France

LEO Pharma Investigational Site

Nice, , France

LEO Pharma Investigational Site

Paris, , France

LEO Pharma Investigational Site

Toulouse, , France

LEO Pharma Investigational Site

Aachen, , Germany

LEO Pharma Investigational Site

Berlin, , Germany

LEO Pharma Investigational Site

Bochum, , Germany

LEO Pharma Investigational Site

Dresden, , Germany

LEO Pharma Investigational Site

Düsseldorf, , Germany

LEO Pharma Investigational Site

Erlangen, , Germany

LEO Pharma Investigational Site

Oldenburg, , Germany

Countries

United States; Denmark; France; Germany

References

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.

Reference Type: DERIVED

PMID: 33687069 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-003615-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EXP-1373

Identifier Type: -

Identifier Source: org_study_id