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Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

NCT03958955 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-03-06

Study results available
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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

Interventions

DRUG

Delgocitinib cream

Cream for topical application.

DRUG

Delgocitinib cream vehicle

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

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Medical Expert · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2020-04-15
Completion
2020-04-30
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958955 on ClinicalTrials.gov