Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Participant has a diagnosis of plaque psoriasis for at least 6 months before the first administration of investigational medicinal product (IMP) as determined by the investigator.
- - Participant has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfil ALL of the following criteria: 1.
- - Participant has no active tuberculosis at screening (negative QuantiFERON® or purified protein derivative [PPD] test).
- - Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of IMP on plaque psoriasis.
- - Participant has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus).
- - Participant has any systemic disease (e.g. renal failure, heart failure, hypertension, liver disease, diabetes, anaemia) considered by the investigator to be clinically significant and uncontrolled.
- - Participant has a known history of Crohn's disease.
- - Participant has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- - Participant has a history of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
- - Participant has a known history of active tuberculosis.
- - Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or baseline.
- - Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or baseline.
- - Participant has a Patient Health Questionnaire-8 (PHQ-8) score of ≥10, corresponding to moderate to severe depression at screening or baseline.
- - Participant has previously received more than 1 tumour necrosis factor α (TNF α) inhibitor.
- - Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17 receptor subunit A, or anti-IL-23 besides ustekinumab.
- - Participant has known or suspected hypersensitivity to any component(s) of the IMPs.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||LEO Pharma|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Plaque Psoriasis, Psoriasis Vulgaris, Psoriasis|
Brodalumab is an anti-interleukin 17 receptor A antibody (IL-17RA) and blocks the inflammatory effects of different IL-17 cytokines (IL-17A, IL-17C, IL-17F, IL-17A/F heterodimer, and IL-17E) in the skin. With increasing availability of novel biologics with new targets, the complexity of choosing the appropriate biologic treatment is ever more challenging for physicians. Therefore, the primary objective of this trial is to compare the efficacy of brodalumab versus guselkumab in adult participants with moderate to severe plaque psoriasis and inadequate response to ustekinumab, thereby providing new scientific information that could support decision making in the clinical setting. The study will run approximately 32 weeks for each participant (including a 2- to 4-weeks screening period and a 28-week treatment period), with the primary endpoint measurement at Week 16. Participants receive subcutaneous injections of brodalumab or guselkumab. Dummy injections are also given, so participants, assessors, and investigators are unaware of which treatment is given.
Experimental: Arm 1 (brodalumab + dummy 1)
Participants receive: Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks.
Active Comparator: Arm 2 (guselkumab + dummy 2)
Participants receive: Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
Biological: - Brodalumab
Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
Other: - Placebo
The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance
Biological: - Guselkumab
Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.