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Efficacy of Roflumilast in the Treatment of Psoriasis (PSORRO)

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

Roflumilast 500 microgram daily (capsule)

Placebo (capsule)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2020
Last Updated
June 27, 2023
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04549870
Brief Title
Efficacy of Roflumilast in the Treatment of Psoriasis
Acronym
PSORRO
Official Title
Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
Roflumilast 500 microgram daily (capsule)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (capsule)
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Other Intervention Name(s)
Daxas
Intervention Description
Treatment according to national roflumilast guidelines
Primary Outcome Measure Information:
Title
PASI75
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Egeberg, MD, PhD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Roflumilast in the Treatment of Psoriasis

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