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

NCT03478280 | Unknown Phase 4 DMC

• 1 other identifier: PsoPET2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• The aortic wall inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.

  The average of maximum TBR values (MeanTBRmax) of the entire aorta at baseline and at week 16

  16 weeks

Secondary Outcomes (3)

• The splenic inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.

  16 weeks

• The aortic wall subsegment inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.

  16 weeks

• The skin inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.

  16 weeks

Study Arms (2)

Brodalumab

ACTIVE COMPARATOR

Subjects will receive 210 mg of Kyntheum administered by subcutaneous injection at Weeks 0, 1 and 2 followed by 210 mg every other week (EOW) thereafter.

Drug: Brodalumab

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo doses administered by subcutaneous injection at Weeks 0, 1 and 2 followed by placebo EOW thereafter.

Drug: Placebos

Interventions

Brodalumab DRUG

Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period

Also known as: Kyntheum

Brodalumab

Placebos DRUG

Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-Danish speaking
• Known or suspected allergy or reaction to any component of the IMP formulation.
• History of inflammatory bowel disease, arthritis (not including psoriatic arthritis), systemic lupus erythematosus, and active inflammatory skin diseases.
• A history of malignancies within the past five years (excluding localized non-melanoma skin cancer).
• Topical corticosteroid treatment (class III or stronger) and/or ultraviolet type B phototherapy within 2 weeks prior to randomization
• Treatment with psoralen plus ultraviolet type A photochemotherapy, methotrexate, cyclosporine, acitretin, or fumaric acid esters within 4 weeks prior to randomization.
• 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.
• Scheduled surgery during the trial period (expect minor minimally invasive procedures).
• Systemic infection or fever within 7 days prior to FDG-PET/CT.
• Severe obesity (\> 150 kg due to a PET/CT scanner limitation).
• Presence of uncontrolled diabetes mellitus (HbA1c \> 75 mmol/mol and/or blood sugar \> 11.1 mmol/l and/or clinical judgment).
• History of coagulation defects (clinical judgment).
• Active or latent tuberculosis requiring treatment.
• Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• LEO Pharma: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anne Bregnhøj, MD, PhD

CONTACT

+45 2183 5720; annebreg@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: A randomised, double-blind, placebo-controlled, trial

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 27, 2018
• Study Start: September 15, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

DK (1)