Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Study Purpose

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses. The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	12 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Subject was diagnosed with chronic plaque psoriasis at least 6 months before randomisation.

- Subject has a diagnosis of moderate-to-severe plaque psoriasis as defined by PASI ≥12, sPGA ≥3, and body surface area ≥10% at screening and at baseline.

- Subject, in whom topical therapy is not adequate, and who is a candidate for systemic therapy.

- Subject has no evidence of active or latent tuberculosis according to local standard of care.

Key

Exclusion Criteria:

- Subject is diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema).

- Subject has been vaccinated with a tetanus toxoid-containing vaccine ≤18 months prior to first dose of investigational medicinal product (IMP).

For EU and UK: Subject has been vaccinated with a TT-containing vaccine within 5 years prior to the first dose of IMP.

- Subject has developed or experienced either Guillian-Barre syndrome, encephalopathy, Arthus-type hypersensitivity, or severe allergic reactions in connection with previous Tdap or Td vaccine.

- Subject with chronic or recurrent infections, or active infection, systemically treated within 4 weeks prior to first dose of IMP.

- Subject has a known history of Crohn's disease.

- Subject has any active malignancy or a history of any malignancy within 5 years.

- Subject has a history of suicidal behaviour and has suicidal ideation with some intent to act or specific plan and intent.

- Subject has a history of depressive disorder with severe episode(s) within the last 2 years.

- Subject has received anti-IL-12/23p40 for less than 12 months prior to the first dose of IMP or has previously no response to anti-IL-12/23p40 therapy.

- Subject has previously received anti-IL-17 therapy.

Trial Details

Trial ID: 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.	NCT04305327
Phase 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.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	LEO Pharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Expert
Principal Investigator Affiliation	LEO Pharma
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis

Arms & Interventions

Arms

Experimental: Brodalumab

Brodalumab for 52 weeks. The dose will be determined by the participant's body weight.

Active Comparator: Ustekinumab

Ustekinumab for 52 weeks. The dose will be determined by the participant's body weight.

Placebo Comparator: Placebo/brodalumab

Placebo for the first 12 weeks and brodalumab for the following 40 weeks. The dose will be determined by the participant's body weight.

Placebo Comparator: Placebo/ustekinumab

Placebo for the first 12 weeks and ustekinumab for the following 40 weeks. The dose will be determined by the participant's body weight.

Interventions

Drug: - Brodalumab

Solution for subcutaneous injection.

Drug: - Ustekinumab

Solution for subcutaneous injection.

Drug: - Placebo

The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.

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.

International Sites

LEO Pharma Investigational Site, Brussels, Belgium

Status

Recruiting

Address

LEO Pharma Investigational Site

Brussels, , 1200

Site Contact

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