PsoriasisPhase 4NCT03478280
Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis
A Phase 4 study testing Brodalumab in people with Psoriasis, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2018to 15 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- No history of varicella zoster infection and negative varicella antibody test (until varicella vaccination is completed).
- History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
- History of intravenous drug use.
- History of attempted suicide or is at significant risk of suicide.
- Major surgery within the past 3 months.
- Pregnancy or lactation (Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and until 12 weeks after discontinuation of treatment with brodalumab.
- Claustrophobia.
- Reduced renal function (serum creatinine > 200 μmol/L or cr-EDTA clearance < 30 ml/min)
- Any disorder, including but not limited to, cardiovascular, lung, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:
- Affect the safety of the subject throughout the trial.
- Influence the findings of the trial or their interpretations.
- Impede the subject's ability to complete the entire duration of trial.
- A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), vasectomised partner (given that the subject is monogamous). The subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test. A female is defined as not being of child bearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Anne Bregnhøj, PhD, annebreg@rm.dk
About this study
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
- Being tested
- Brodalumab, Placebos
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabDrug
Also called Kyntheum
Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period
PlacebosDrug
Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (3)
The splenic inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
The spleen-to-liver ratio (SLR) based on splenic and liver mean standardised uptake values (SUVmean)
Measured: 16 weeks
The aortic wall subsegment inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
The average of maximum TBR values (MeanTBRmax) of the ascending, aortic arch, descending, suprarenal, and infrarenal aorta at baseline and at week 16
Measured: 16 weeks
The skin inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
Severity of psoriasis measured by PASI score at baseline and at week 16
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start15 Sep 2018
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, double-blind, placebo-controlled, trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Anne Bregnhøj, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478280
- Sponsor's protocol ID
- PsoPET2
- Status last verified
- Jul 2019
- First submitted
- 13 Mar 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis
- ClinicalTrials.gov ID
- NCT03478280
- Acronym / sponsor ID
- PsoPET2
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, double-blind, placebo-controlled, trial
| Arm | Type | Receives |
|---|---|---|
| Brodalumab | Active comparator | Drug: BrodalumabSubjects 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. |
| Placebo | Placebo comparator | Drug: PlacebosSubjects will receive placebo doses administered by subcutaneous injection at Weeks 0, 1 and 2 followed by placebo EOW thereafter. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabAlso: KyntheumSubjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period | Drug | Brodalumab |
| PlacebosSubjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period | Drug | Placebo |
Primary outcome
The aortic wall inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
Time frame: 16 weeks
The average of maximum TBR values (MeanTBRmax) of the entire aorta at baseline and at week 16
3 secondary outcomes
The splenic inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
Time frame: 16 weeks
The aortic wall subsegment inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
Time frame: 16 weeks
The skin inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brodalumab in people with Psoriasis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Bregnhøj, MD, PhD (+45 2183 5720, annebreg@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aortic wall inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.