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

Conditions

• Lichen Sclerosus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Delgocitinib — DRUG
  Participants will receive delgocitinib BID via topical application.
• Cream Vehicle — DRUG
  Participants will receive cream vehicle BID via topical administration.

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

Jun 2026

Primary completion

Mar 10, 2028

Completion

Dec 29, 2028

Study Design

Enrollment

652 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Number of Participants Achieving IGA-LS TS at Week 12 [ Time Frame: Week 12 ]

Central Contacts

• Clinical Disclosure
  (+45) 4494 5888
  [email protected]

Locations (5)

Find similar trials in Birmingham, AL

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