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Efficacy of Roflumilast in the Treatment of Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥18 years.
  • - Chronic stable plaque psoriasis (min duration 6 months) - PASI >8.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04549870
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Bispebjerg Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alexander Egeberg, MD, PhD
Principal Investigator Affiliation Bispebjerg Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Roflumilast

Roflumilast 500 microgram daily (capsule)

Placebo Comparator: Placebo

Placebo (capsule)

Interventions

Drug: - Roflumilast

Treatment according to national roflumilast guidelines

Contact a Trial Team

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International Sites

Bispebjerg Hospital, Copenhagen, Denmark

Status

Recruiting

Address

Bispebjerg Hospital

Copenhagen, ,

Site Contact

Alexander Egeberg

alexander.egeberg@gmail.com

+4524215421

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