Clinical trial NCT04305327: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
Official title: A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12.
timeFrame: Week 12
measure: sPGA Score of 0, Assessed at Week 12.
timeFrame: Week 12
measure: PASI 90 Response, Assessed at Week 12.
timeFrame: Baseline to Week 12
measure: PASI 100 Response, Assessed at Week 12.
timeFrame: Baseline to Week 12
measure: Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12.
timeFrame: Week 12
measure: Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12.
timeFrame: Week 12
measure: Overall Number of Adverse Events (AEs)
timeFrame: Up to approximately 5 months
measure: Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52.
timeFrame: Week 4, Week 16, and Week 52
measure: Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52.
timeFrame: Week 8, Week 12, and Week 52
measure: Blood Levels of T-cell Subsets (CD4+ and CD8+), Assessed at Weeks 8, 12, and 52.
timeFrame: Week 8, Week 12, and Week 52
measure: Serum Concentrations of Brodalumab, Assessed at Weeks 4, 8, 10, 12, 16, 22, and 52.
timeFrame: Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52
measure: Anti-tetanus Toxoid Antibodies ≥0.1 IU/mL, Assessed at Week 12.
timeFrame: Week 12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: LEO Pharma Investigational Site
city: Liège
country: Belgium
facility: LEO Pharma Investigational Site
city: Toulouse
country: France
facility: LEO Pharma Investigational Site
city: Bad Bentheim
country: Germany
facility: LEO Pharma Investigational Site
city: Essen
country: Germany
facility: LEO Pharma Investigational Site
city: Frankfurt
country: Germany
facility: LEO Pharma Investigational Site
city: Hamburg
country: Germany
facility: LEO Pharma Investigational Site
city: Hamburg
country: Germany
facility: LEO Pharma Investigational Site
city: Langenau
country: Germany
facility: LEO Pharma Investigational Site
city: Lübeck
country: Germany
facility: LEO Pharma Investigational Site
city: Mainz
country: Germany
facility: LEO Pharm Investigational Site
city: Münster
country: Germany
facility: LEO Pharma Investigational Site
city: Athens
country: Greece
facility: LEO Pharma Investigational Site
city: Piraeus
country: Greece
facility: LEO Pharma Investigational Site
city: Thessaloníki
country: Greece
facility: LEO Pharma Investigational Site
city: Debrecen
country: Hungary
facility: LEO Pharma Investigational Site
city: Orosháza
country: Hungary
facility: LEO Pharma Investigational Site
city: Brescia
country: Italy
facility: LEO Pharma Investigational Site
city: Napoli
country: Italy
facility: LEO Pharma Investigational Site
city: Padova
country: Italy
facility: LEO Pharma Investigational Site
city: Iwonicz-Zdrój
country: Poland
facility: LEO Pharma Investigational Site
city: Poznań
country: Poland
facility: LEO Pharma Investigational Site
city: Skierniewice
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Alicante
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Granada
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Pontevedra
country: Spain
facility: LEO Pharma Investigational Site
city: Valencia
country: Spain
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: