NCT04549870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

September 8, 2020

Last Update Submit

June 27, 2023

Conditions

Psoriasis

Outcome Measures

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.

    12 weeks

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

Roflumilast 500 microgram daily (capsule)

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

Placebo (capsule)

Drug: Roflumilast

Interventions

RoflumilastDRUG

Treatment according to national roflumilast guidelines

Also known as: Daxas
PlaceboRoflumilast

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 40403838DERIVED

  • 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.

    PMID: 37465323DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexander Egeberg, MD, PhD

    Bispebjerg Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 16, 2020

Study Start

January 1, 2021

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)