Overview

A Trial to Learn if Delgocitinib Can Help Reduce Symptoms in People With Lichen Sclerosus

Status:
NOT_YET_RECRUITING
Trial end date:
2028-12-29
Target enrollment:
Participant gender:
Summary
The main purpose of this trial is to learn if female participants have reduced lichen sclerosus (LS) symptoms after treatment with delgocitinib. The researchers are focusing on female participants because LS is more likely to affect females compared to males. The trial will be conducted in 2 parts. Part 1 of the trial (including dose selection) will only enroll female participants with LS. The selected dose will then be evaluated in Part 2 of the trial, which will be open to both female and male participants with LS. The selected dose will remain blinded in Part 2. Assessment of efficacy and safety of delgocitinib cream in male participants with LS will be evaluated in a substudy. For each participant, the trial will last at least 55 weeks and up to 60 weeks.
Phase:
PHASE3
Details
Lead Sponsor:
LEO Pharma
Treatments:
delgocitinib