NCT04305327|TerminatedPhase 3ResultsDMCFDA Drug

Study Stopped

Early terminated due to difficulty recruiting participants

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

EMBRACE 1

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

LEO Pharma ClinicalTrials.gov

Compare

3 other identifiers

LP0160-13962019-001868-30U1111-1282-4459

Study Type

interventional

Target

Locations

8 countries

Sites

Timeline

RegisteredMar 2020

StartedDec 2022

CompletionMay 2023

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Dec 2022

Shorter than P25 for phase_3

Geographic Reach

8 countries

35 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

March 10, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed

2.7 years until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed

10 months until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed

Last Updated

March 14, 2025

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

March 10, 2020

Results QC Date

December 18, 2023

Last Update Submit

February 21, 2025

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12.
PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
Baseline to Week 12

Secondary Outcomes (12)

Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12.
Week 12
sPGA Score of 0, Assessed at Week 12.
Week 12
PASI 90 Response, Assessed at Week 12.
Baseline to Week 12
PASI 100 Response, Assessed at Week 12.
Baseline to Week 12
Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12.
Week 12
+7 more secondary outcomes

Study Arms (4)

Brodalumab

EXPERIMENTAL

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

Drug: Brodalumab

Ustekinumab

ACTIVE COMPARATOR

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

Drug: Ustekinumab

Placebo/brodalumab

PLACEBO COMPARATOR

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

Drug: BrodalumabDrug: Placebo

Placebo/ustekinumab

PLACEBO COMPARATOR

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

Drug: UstekinumabDrug: Placebo

Interventions

BrodalumabDRUG

Solution for subcutaneous injection.

Also known as: Kyntheum®

BrodalumabPlacebo/brodalumab

UstekinumabDRUG

Solution for subcutaneous injection.

Also known as: Stelara®

Placebo/ustekinumabUstekinumab

PlaceboDRUG

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

Placebo/brodalumabPlacebo/ustekinumab

Eligibility Criteria

Age12 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.