- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549870
Efficacy of Roflumilast in the Treatment of Psoriasis (PSORRO)
Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Copenhagen, Denmark
- Bispebjerg Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Roflumilast
Roflumilast 500 microgram daily (capsule)
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Treatment according to national roflumilast guidelines
Other Names:
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Placebo Comparator: Placebo
Placebo (capsule)
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Treatment according to national roflumilast guidelines
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PASI75
Time Frame: 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.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alexander Egeberg, MD, PhD, Bispebjerg Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20013697
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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