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Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis

NCT03478280•Aarhus University Hospital

View on ClinicalTrials.gov

Summary

A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent obtained from the subject prior to performing any protocol-related procedures.
•2. Age 40 and above.
•3. Diagnosis of chronic plaque psoriasis confirmed by a dermatologist
•4. PASI ≥ 10

Exclusion Criteria

•1. Non-Danish speaking
•2. Known or suspected allergy or reaction to any component of the IMP formulation.
•3. History of inflammatory bowel disease, arthritis (not including psoriatic arthritis), systemic lupus erythematosus, and active inflammatory skin diseases.
•4. A history of malignancies within the past five years (excluding localized non-melanoma skin cancer).
•5. Topical corticosteroid treatment (class III or stronger) and/or ultraviolet type B phototherapy within 2 weeks prior to randomization
•6. Treatment with psoralen plus ultraviolet type A photochemotherapy, methotrexate, cyclosporine, acitretin, or fumaric acid esters within 4 weeks prior to randomization.
•7. Treatment with adalimumab, etanercept, infliximab, cosentyx, or ixekizumab within 12 weeks, ustekinumab within 24 weeks, or other immunosuppressive or anti-inflammatory agents within 5 half-lives of the active substance prior to the FDG-PET/CT, respectively.
•8. Scheduled surgery during the trial period (expect minor minimally invasive procedures).
•9. Systemic infection or fever within 7 days prior to FDG-PET/CT.
•10. Severe obesity (\> 150 kg due to a PET/CT scanner limitation).
+18 more criteria

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Key Dates

Start Date

September 15, 2018

Primary Completion Date

March 15, 2020

Completion Date

March 15, 2020

Last Updated

July 10, 2019

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

Brodalumab

DRUG

Placebos

DRUG

Contacts

Anne Bregnhøj, MD, PhD

CONTACT

+45 2183 5720 annebreg@rm.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis

Inclusion Criteria

Exclusion Criteria

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