A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus

NCT07335588 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: LP0133-23952025-524873-17-00U1111-1333-1675
• Study Type: interventional
• Target: 652
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving IGA-LS TS at Week 12

  Week 12

Secondary Outcomes (18)

• Number of Participants Achieving IGA-LS TS at Week 8

  Week 8

• Change in Clinical Lichen Sclerosus Score (CLISSCO) from Baseline to Week 12

  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

  Baseline to Week 12

• 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

  Baseline to Week 8

• Number of Participants Achieving a Reduction of Itch NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 12 in Participants with Baseline Itch NRS Score ≥4

  Baseline to Week 12

Study Arms (11)

Part 1: Delgocitinib Cream 20 mg/g

EXPERIMENTAL

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.

Drug: Delgocitinib

Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 1: Delgocitinib Cream 8 mg/g

EXPERIMENTAL

Participants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period.

Drug: Delgocitinib

Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 1: Cream Vehicle

PLACEBO COMPARATOR

Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.

Drug: Cream Vehicle

Part 2: Delgocitinib Cream (Selected Dose)

EXPERIMENTAL

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.

Drug: Delgocitinib

Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose)

EXPERIMENTAL

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.

Drug: Delgocitinib; Drug: Cream Vehicle

Part 2: Cream Vehicle

PLACEBO COMPARATOR

Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.

Drug: Cream Vehicle

Interventions

Delgocitinib DRUG

Participants will receive delgocitinib BID via topical application.

Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g; Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g; Part 1: Delgocitinib Cream 20 mg/g; Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle; Part 1: Delgocitinib Cream 8 mg/g; Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle; Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose); Part 2: Delgocitinib Cream (Selected Dose); Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle

Cream Vehicle DRUG

Participants will receive cream vehicle BID via topical administration.

Part 1: Cream Vehicle; Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g; Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g; Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle; Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle; Part 2: Cream Vehicle; Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose); Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants with severe urinary incontinence. Incontinence is considered severe if it occurs on most days and more than a few drops at a time.
• Female participants: Suspected clinically (or confirmed diagnostically) of having active infection in the anogenital area, including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma genitalium, bacterial vaginosis, or herpes simplex. Participants who test positive for sexually transmitted disease (STD)/bacterial vaginosis (BV)/anogenital candidiasis during screening can be treated, and if repeat testing is negative, these participants can be enrolled. If treatment is needed, the screening period can be extended to 6 weeks to accommodate the treatment and washout requirements.
• Male participants: Suspected clinically (or confirmed diagnostically) of having active infection in the anogenital area, including candidiasis, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, or herpes simplex. Participants who test positive for STD/anogenital candidiasis during screening can be treated, and if repeat testing is negative, these participants can be enrolled. If treatment is needed, the screening period can be extended to 6 weeks to accommodate the treatment and washout requirements.
• Clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
• Clinically significant infections are defined as:
• A systemic infection.
• A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
• Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the trial period.
• History of cancer:
• Female participants: Participants who have had basal cell carcinoma or localized SCC of the skin (outside the anogenital area), or in situ carcinoma of the cervix are eligible provided that curative therapy was successfully completed at least 12 months prior to screening.

Sponsors & Collaborators

• LEO Pharma: lead

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

delgocitinib

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Central Study Contacts

Clinical Disclosure

CONTACT

(+45) 4494 5888; disclosure@leo-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share