Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2021-01-01
2022-12-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Roflumilast
Roflumilast 500 microgram daily (capsule)
Roflumilast
Treatment according to national roflumilast guidelines
Placebo
Placebo (capsule)
Roflumilast
Treatment according to national roflumilast guidelines
Interventions
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Roflumilast
Treatment according to national roflumilast guidelines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Mette Gyldenløve
MD, PhD
Principal Investigators
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Alexander Egeberg, MD, PhD
Role: STUDY_DIRECTOR
Bispebjerg Hospital
Locations
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Bispebjerg Hospital
Copenhagen, , Denmark
Countries
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References
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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 May 20:S0022-202X(25)00491-9. doi: 10.1016/j.jid.2025.04.034. Online ahead of print.
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.
Other Identifiers
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H-20013697
Identifier Type: -
Identifier Source: org_study_id
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