Efficacy of Roflumilast in the Treatment of Psoriasis | NCT04549870

Studies
Efficacy of Roflumilast in the Treatment of Psoriasis

NCT04549870

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jun 28, 2023Actual

Enrollment

46Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

Roflumilast

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 12, 2022Actual

Completion Date

Dec 12, 2022Actual

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Sep 14, 2020

First Posted Date

Sep 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2023

Last Update Posted Date

Jun 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Roflumilast	Active Comparator	Roflumilast 500 microgram daily (capsule)	Drug: Roflumilast
Placebo	Placebo Comparator	Placebo (capsule)	Drug: Roflumilast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug	Treatment according to national roflumilast guidelines	Placebo Roflumilast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alexander Egeberg, MD, PhD	Bispebjerg Hospital	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40403838	Derived	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.
37465323

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases