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Clinical Trials/NCT04549870
NCT04549870CompletedPhase 2

Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial

Bispebjerg Hospital1 site in 1 country46 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
PASI75

Study Overview

Brief Summary

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.

Detailed Description

Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis.

Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial.

Participants: Patients ≥18 years with plaque psoriasis.

Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups continue for an additional 12 weeks open-label treatment.

Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years
  • Chronic stable plaque psoriasis (min duration 6 months)
  • Body mass index (BMI) > 20 kg/m2
  • Candidate for systemic treatment of psoriasis
  • Negative pregnancy test (only women)
  • Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) (only applying for fertile women)

Exclusion Criteria

  • Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
  • Current tuberculosis
  • Current viral hepatitis
  • Heart failure (NYHA III-IV)
  • Moderate or severe liver failure (Child-Pugh B-C)
  • Current or former malignancy (basal cell carcinoma excluded)
  • Current or former depression with suicidal ideation
  • Topical therapy for psoriasis during within 2 of randomization or during study
  • Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study
  • Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
  • Confirmed pregnancy
  • Planned pregnancy within 6 months
  • Breast feeding
  • Blood donation during study
  • Inability to complete study

Arms & Interventions

Roflumilast

Active Comparator

Roflumilast 500 microgram daily (capsule)

Intervention: Roflumilast (Drug)

Placebo

Placebo Comparator

Placebo (capsule)

Intervention: Roflumilast (Drug)

Outcomes

Primary Outcomes

PASI75

Time Frame: 12 weeks

Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12. PASI is a measure of psoriatic disease severity.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mette Gyldenløve

MD, PhD

Bispebjerg Hospital

Study Sites (1)

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