NCT03958955|TerminatedPhase 2ResultsFDA Drug

Study Stopped

Terminated due to recruitment challenges.

Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

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

LEO Pharma ClinicalTrials.gov

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2 other identifiers

EXP-13732018-003615-22

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredMay 2019

StartedJul 2019

CompletionApr 2020

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jul 2019

Shorter than P25 for phase_2

Geographic Reach

4 countries

19 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

May 20, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 28, 2021

Completed

Last Updated

March 6, 2025

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 20, 2019

Results QC Date

April 14, 2021

Last Update Submit

February 21, 2025

Conditions

Discoid Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

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.
Week 6

Secondary Outcomes (7)

Number of Adverse Events (AEs) up to Week 6.
Week 0 to Week 6
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
Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.
Week 0 to Week 6
Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.
Week 0 to Week 6
+2 more secondary outcomes

Study Arms (2)

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 6 weeks

Drug: Delgocitinib cream

Delgocitinib cream vehicle

PLACEBO COMPARATOR

Delgocitinib cream vehicle applied twice daily for 6 weeks

Drug: Delgocitinib cream vehicle

Interventions

Delgocitinib creamDRUG

Cream for topical application.

Also known as: LEO 124249 cream

Delgocitinib cream 20 mg/g

Delgocitinib cream vehicleDRUG

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

Also known as: LEO 124249 cream vehicle

Delgocitinib cream vehicle

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+11 more criteria

Contact the study team to confirm eligibility.