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CompletedNCT04549870PSORROUpdated Jun 28, 2023

Efficacy of Roflumilast in the Treatment of Psoriasis

A Phase 2 interventional study of Roflumilast in Psoriasis, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Bispebjerg Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Roflumilast

    Roflumilast 500 microgram daily (capsule)

    Drug: Roflumilast

  • Placebo comparator
    Placebo

    Placebo (capsule)

    Drug: Roflumilast

Interventions

  • DrugRoflumilast

    Treatment according to national roflumilast guidelines

    Also known as: Daxas

06

What researchers measure

Primary outcomes

  1. PASI75

    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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen, Denmark
08

References and documents

Publications

  • Baez E, Gyldenlove M, Ben Abdallah H, Emmanuel T, Sorensen JA, Thomsen SF, Zachariae C, Egeberg A, Skov L, Iversen L, Johansen C. Oral Roflumilast Suppresses Proinflammatory Cytokine Signaling and Reduces CD4+ T-Cell and Neutrophil Infiltration in Psoriasis. J Invest Dermatol. 2025 Dec;145(12):3079-3088.e3. doi: 10.1016/j.jid.2025.04.034. Epub 2025 May 20. PubMed 40403838 ↗
  • Gyldenlove M, Meteran H, Sorensen JA, Fage S, Yao Y, Lindhardsen J, Nissen CV, Todberg T, Thomsen SF, Skov L, Zachariae C, Iversen L, Nielsen ML, Egeberg A. Efficacy and safety of oral roflumilast for moderate-to-severe psoriasis-a randomized controlled trial (PSORRO). Lancet Reg Health Eur. 2023 Apr 21;30:100639. doi: 10.1016/j.lanepe.2023.100639. eCollection 2023 Jul. PubMed 37465323 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04549870
Lead sponsor
Bispebjerg Hospital
Responsible party
Mette Gyldenløve (MD, PhD, Bispebjerg Hospital) — Principal investigator
First posted
Sep 16, 2020
Start date
Jan 1, 2021
Primary completion
Dec 12, 2022
Completion
Dec 12, 2022
Last update
Jun 28, 2023

Study contacts

Alexander Egeberg, MD, PhD
study director · Bispebjerg Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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