A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis

Conditions

• Palmoplantar Pustulosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Delgocitinib cream — DRUG
  Topical application
• Vehicle cream — DRUG
  Topical application

Study Details

The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.

Key Dates

Start date

Sep 11, 2025

Status verified

Jun 2026

Primary completion

Dec 14, 2026

Completion

Dec 14, 2026

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Delgocitinib 20 mg/g
  Participants with mild to severe PPP will receive 20 mg/g of delgocitinib cream twice a day for 16 weeks.
• Placebo Comparator: Cream Vehicle
  Participants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks.

Primary Outcome Measure

Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16 [ Time Frame: Baseline to Week 16 ]

Central Contacts

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

Locations (7)

Find similar trials in Fountain Valley, CA

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