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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream compared with cream vehicle in the treatment of adult participants with mild to severe lichen sclerosus (LS). The researchers are focusing on female participants because LS is more likely to affect females compared to males. The trial is conducted in 2 parts. Part 1 of the trial enrolls female participants with LS and results in the selection of the optimal dose for Part 2. The selected dose will then be evaluated in Part 2, which will enroll both female and male participants. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed and dated informed consent has been obtained prior to any protocol-related procedures.
• Age ≥18 years at the time of signing informed consent.
• Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
• Female participants or male participants (assigned sex at birth and has not had any gender affirming medical procedures to their genital area) with LS in the anogenital area, regardless of treatment history. The diagnosis must be based on typical clinical features and supported by biopsy. A biopsy must be taken if there is no previous documented biopsy to support the diagnosis.
• Note: Participants who also have LS-affected areas outside the anogenital area are allowed to be enrolled but these areas will not be treated with investigational medicinal product (IMP). Participants with newly diagnosed LS can be included, as well as participants who have progressive LS (including existing architectural changes).
• Disease severity graded as mild to severe at screening and baseline according to IGA-LS score (ie, an IGA-LS score of ≥2).
• Female participants: A woman of childbearing potential (WOCBP) must agree to use a highly effective or acceptable form of birth control throughout the trial up until the last application of IMP. Male participants: Contraceptive requirements are not applicable for male participants.
Locations
United States
Alabama
LEO Pharma Investigational Site
RECRUITING
Birmingham
Washington, D.c.
LEO Pharma Investigational Site
RECRUITING
Washington D.c.
Florida
LEO Pharma Investigational Site
RECRUITING
Miami
LEO Pharma Investigational Site
RECRUITING
Tamarac
New York
LEO Pharma Investigational Site
RECRUITING
New York
Other Locations
Canada
LEO Pharma Investigational Site
RECRUITING
Montreal
LEO Pharma Investigational Site
RECRUITING
Québec
Contact Information
Primary
Clinical Disclosure
disclosure@leo-pharma.com
(+45) 4494 5888
Time Frame
Start Date:2026-05-01
Estimated Completion Date:2028-12-29
Participants
Target number of participants:652
Treatments
Experimental: Part 1: Delgocitinib Cream 20 mg/g
Participants will receive delgocitinib cream 20 mg/g twice daily (BID) in both the 12-week initial treatment period and the 40-week continuation treatment period.
Experimental: Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle
Participants will receive delgocitinib cream 20 mg/g BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Experimental: Part 1: Delgocitinib Cream 8 mg/g
Participants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Experimental: Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle
Participants will receive delgocitinib cream 8 mg/g BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Experimental: Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream 20 mg/g BID in the 40-week continuation treatment period.
Experimental: Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream 8 mg/g BID in the 40-week continuation treatment period.
Placebo_comparator: Part 1: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Experimental: Part 2: Delgocitinib Cream (Selected Dose)
Participants will receive delgocitinib cream, at the selected dose from Part 1, BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Experimental: Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle
Participants will receive delgocitinib cream, at the selected dose from Part 1, BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Experimental: Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose)
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream, at the selected dose from Part 1, BID in the 40-week continuation treatment period.
Placebo_comparator: Part 2: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.