Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (EMBRACE 1)

LEO Pharma

Status and phase: Terminated; Phase 3

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Brodalumab; Drug: Ustekinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04305327

LP0160-1396

U1111-1282-4459 (Other Identifier)

2019-001868-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Brodalumab

Experimental group

Description:

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

Treatment:

Drug: Brodalumab

Ustekinumab

Active Comparator group

Description:

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

Treatment:

Drug: Ustekinumab

Placebo/brodalumab

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Brodalumab

Placebo/ustekinumab

Placebo Comparator group

Description:

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

Treatment:

Drug: Ustekinumab

Drug: Placebo