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PSORRO: Efficacy of Roflumilast in the Treatment of Psoriasis

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04549870
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Roflumilast

Roflumilast 500 microgram daily (capsule)

Drug: Roflumilast
Treatment according to national roflumilast guidelines
Other Names:
  • Daxas

    		•
    Placebo Comparator: Placebo

    Placebo (capsule)

    Drug: Roflumilast
    Treatment according to national roflumilast guidelines
    Other Names:
  • Daxas

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PASI75 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital Copenhagen Denmark

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Study Director: Alexander Egeberg, MD, PhD, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mette Gyldenløve, MD, PhD, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT04549870
    Other Study ID Numbers:
    • H-20013697
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Jul 8, 2022