Trial Efficacy Safety of Delgocitinib Cream in Adult Participants Lichen Sclerosus
Research type
Research Study
Full title
A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period.
IRAS ID
1013747
Contact name
Stephany Micallef
Contact email
Sponsor organisation
Leo Pharma A/A
Clinicaltrials.gov Identifier
Research summary
This is a trial to investigate the efficacy and safety of delgocitinib cream in adult participants with lichen sclerosus (LS) in the genitals and surrounding area. Trial duration is about 14 months. The main purpose of this trial is to learn if female participants have reduced LS symptoms in the genitals and surrounding area after treatment with delgocitinib. The researchers are focusing on female participants because LS is more likely to affect women compared to men. This trial will have 2 parts. Part 1 will include female participants; Part 2 will include females and males. Participants will receive delgocitinib or a placebo, or both. A placebo looks like a treatment but does not have any medicine in it. Researchers use placebos to help make sure the effects they find in trials are caused by treatments. This will be a “double-blind” trial. This means none of the participants, doctors, or other trial staff will know what trial treatment each participant receives. Part 1 participants will be assigned to 1 of 3 treatment groups: a low or high dose of delgocitinib cream, or the placebo cream. Participants will use the cream twice a day for 12 weeks. Then for the next 40 weeks, the participants will either continue their same treatment or change to one of the other treatments. When all participants have completed 12 weeks of treatment, the researchers will determine which of the 2 delgocitinib cream doses to use for Part 2. Part 2 participants will be assigned to 1 of 2 treatment groups: the delgocitinib cream dose chosen from Part 1, or the placebo cream. Participants will use the cream twice a day for 12 weeks. Then for the next 40 weeks, the participants will either continue their same treatment or change to the other treatment. At different times throughout the trial, the researchers will do the tests like checking participants’ health and disease , taking blood, urine, and tissue samples, giving participants questionnaires about their LS symptoms.
REC name
London - Riverside Research Ethics Committee
REC reference
26/LO/0300
Date of REC Opinion
21 May 2026
REC opinion
Further Information Favourable Opinion