NCT04305327: EMBRACE 1

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

Terminated Phase 3 Results posted Last updated 14 March 2025

What this trial tests

Phase 3 trial testing Brodalumab in Psoriasis in 12 participants. Terminated before completion.

Timeline

7 December 2022

Primary endpoint
5 May 2023

5 May 2023

Quick facts

Lead sponsor	LEO Pharma
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	7 December 2022
Primary completion	5 May 2023
Estimated completion	5 May 2023
Sites	35 locations across France, Italy, Greece, Belgium, Germany, Hungary, Poland, Spain

Drugs / interventions tested

• Brodalumab (BRODALUMAB) — full drug profile →
• Ustekinumab (ustekinumab) — full drug profile →
• Placebo

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

LEO Pharma — full company profile →

Who can join

Adults 12 to 17, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. Primary · Baseline to 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.

Group	Value	95% CI
Brodalumab	NA
Placebo/Ustekinumab	NA

PASI 90 Response, Assessed at Week 12. Secondary · Baseline to Week 12

PASI 90 response is defined as having at least 90% 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, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Group	Value	95% CI
Brodalumab	NA
Placebo/Ustekinumab	NA

PASI 100 Response, Assessed at Week 12. Secondary · Baseline to Week 12

PASI 100 response is defined as having at least 100% 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, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Group	Value	95% CI
Brodalumab	NA
Placebo/Ustekinumab	NA

Overall Number of Adverse Events (AEs) Secondary · Up to approximately 5 months

An AE is defined as any untoward medical occurrence in subjects or clinical investigation participants administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may je

Any AEs

Group	Value	95% CI
Brodalumab	4
Ustekinumab	5
Placebo/Brodalumab	0
Placebo/Ustekinumab	3

Any AEs related to IMP

Group	Value	95% CI
Brodalumab	0
Ustekinumab	3
Placebo/Brodalumab	0
Placebo/Ustekinumab	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brodalumab

Serious: 0/2 (0%)

Deaths: 0/2

Ustekinumab

Serious: 0/6 (0%)

Deaths: 0/6

Placebo/Brodalumab

Serious: 0/2 (0%)

Deaths: 0/2

Placebo/Ustekinumab

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (10 terms — click to expand)

Reaction	System	Brodalumab	Ustekinumab	Placebo/Brodalumab	Placebo/Ustekinumab
Nasopharyngitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Depression rating scale score increased	Investigations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04305327 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biological Treatments for Pediatric Psoriasis: State of the Art and Future Perspectives.
   Diotallevi F, Simonetti O, Rizzetto G, Molinelli E, et al · · 2022 · cited 20× · PMID 36232430 · DOI 10.3390/ijms231911128
2. Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trials.
   Welzel T, Winskill C, Zhang N, Woerner A, et al · · 2021 · cited 19× · PMID 33766063 · DOI 10.1186/s12969-021-00514-4
3. Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis.
   Golhen K, Winskill C, Theiler M, Buettcher M, et al · · 2022 · cited 6× · PMID 36226155 · DOI 10.3389/fmed.2022.944208