Efficacy of Roflumilast in the Treatment of Psoriasis

Sponsor
Bispebjerg Hospital
Study ID
NCT04549870
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Treatment according to national roflumilast guidelines

Study Details

Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.

Key Dates

Start date
Jan 1, 2021
Status verified
Jun 2023
Primary completion
Dec 12, 2022
Completion
Dec 12, 2022

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    Roflumilast 500 microgram daily (capsule)
  • Placebo Comparator: Placebo
    Placebo (capsule)

Primary Outcome Measure

PASI75 [ Time Frame: 12 weeks ]

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