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.
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.
Participants with atypical presentation of LS in the anogenital area where the diagnosis is uncertain, or the suspicion of malignancy exists.
Female participants: History of vulvar squamous cell carcinoma (SCC), including precursor lesions (eg, human papillomavirus-independent [HPV-I] vulvar intraepithelial neoplasia [VIN] and high-grade squamous intraepithelial lesion). Male participants: History of penile SCC, including precursor lesions.
Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV) screening test.
Active dermatologic or gynecologic conditions that could confound the diagnosis of LS or interfere with assessment of the IMP (eg, urinary incontinence-associated dermatitis, genital lichen planus, and genital psoriasis), as assessed by the investigator.
Parallel
Delgocitinib
DrugParticipants will receive delgocitinib BID via topical application.
Cream Vehicle
DrugParticipants will receive cream vehicle BID via topical administration.
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Treatment groupsSee each treatment group below.
Number of Participants Achieving IGA-LS TS at Week 12
Number of Participants Achieving IGA-LS TS at Week 8
Change in Clinical Lichen Sclerosus Score (CLISSCO) from Baseline to Week 12
Number of Participants Achieving a Reduction of Skin Pain Numerical Rating Scale (NRS) Score (Weekly Average) of ≥4 Points from Baseline to Week 12 in Participants with Baseline Skin Pain NRS Score ≥4
Number of Participants Achieving a Reduction of Skin Pain NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 8 in Participants with Baseline Skin Pain NRS Score ≥4
