PsoriasisPhase 3EMBRACE 1NCT04305327
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
A Phase 3 study testing Brodalumab and Ustekinumab in people with Psoriasis, run by LEO Pharma at 35 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Brodalumab and Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 35 sitesin 8 countries
- Study dates
- 7 Dec 2022to 5 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
Germany9 sites
LEO Pharma Investigational Site
Bad Bentheim, 48455
LEO Pharma Investigational Site
Essen, 45122
LEO Pharma Investigational Site
Frankfurt, 60590
LEO Pharma Investigational Site
Hamburg, 20246
LEO Pharma Investigational Site
Hamburg, 20537
LEO Pharma Investigational Site
Langenau, 89129
LEO Pharma Investigational Site
Lübeck, 23538
LEO Pharm Investigational Site
Mainz, 55128
LEO Pharma Investigational Site
Münster, 48149
Poland9 sites
LEO Pharma Investigational Site
Iwonicz-Zdrój, 38-440
LEO Pharma Investigational Site
Lodz, 90-436
LEO Pharma Investigational Site
Poznan, 60-529
LEO Pharma Investigational Site
Skierniewice, 96-100
LEO Pharma Investigational Site
Warsaw, 01-817
LEO Pharma Investigational Site
Warsaw, 02-482
LEO Pharma Investigational Site
Wroclaw, 50-566
LEO Pharma Investigational Site
Wroclaw, 51-318
LEO Pharma Investigational Site
Wroclaw, 52-416
Spain6 sites
LEO Pharma Investigational Site
Alicante, 03010
LEO Pharma Investigational Site
Barcelona, 08041
LEO Pharma Investigational Site
Granada, 18014
LEO Pharma Investigational Site
Madrid, 28046
LEO Pharma Investigational Site
Pontevedra, 36001
LEO Pharma Investigational Site
Valencia, 46018
Greece3 sites
LEO Pharma Investigational Site
Athens, 124-62
LEO Pharma Investigational Site
Piraeus, 18536
LEO Pharma Investigational Site
Thessaloniki, 54643
Italy3 sites
LEO Pharma Investigational Site
Brescia, 25123
LEO Pharma Investigational Site
Naples, 80131
LEO Pharma Investigational Site
Padova, 35128
Belgium2 sites
LEO Pharma Investigational Site
Brussels, 1200
LEO Pharma Investigational Site
Liège, B-4000
Hungary2 sites
LEO Pharma Investigational Site
Debrecen, 4032
LEO Pharma Investigational Site
Orosháza, 5900
About this study
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
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.
- Conditions
- Psoriasis
- Being tested
- Brodalumab, Ustekinumab, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabDrug
Also called Kyntheum®
Solution for subcutaneous injection.
UstekinumabDrug
Also called Stelara®
Solution for subcutaneous injection.
PlaceboDrug
The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab | Experimental | Brodalumab for 52 weeks. The dose will be determined by the participant's body weight. Receives: Drug: Brodalumab |
| Ustekinumab | Active comparator | Ustekinumab for 52 weeks. The dose will be determined by the participant's body weight. Receives: 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. Receives: Drug: Brodalumab; Drug: 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. Receives: Drug: Ustekinumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (12)
Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12.
The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed.
Measured: Week 12
sPGA Score of 0, Assessed at Week 12.
The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed.
Measured: Week 12
PASI 90 Response, Assessed at 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.
Measured: Baseline to Week 12
PASI 100 Response, Assessed at 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.
Measured: Baseline to Week 12
Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12.
CDLQI consists of 10 items addressing the child's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Measured: Week 12
Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12.
FDLQI consists of 10 items addressing the participant's relative perception of the impact of the participant's skin disease on various aspects of his/her quality of life over the last month such as: emotional distress, social life, job and leisure activities, physical well-being, time spent on helping the subject with e.g., treatment procedures, extra housework, and routine household expenditure. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Measured: Week 12
Overall Number of Adverse Events (AEs)
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 jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Up to approximately 5 months
Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52.
Number of participants with a positive post-baseline anti-drug antibody result at weeks 4, 16, and 52.
Measured: Week 4, Week 16, and Week 52
Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52.
Number of participants with detectable levels of Interleukin-17 at weeks 8, 12, and 52.
Measured: Week 8, Week 12, and Week 52
Blood Levels of T-cell Subsets (CD4+ and CD8+), Assessed at Weeks 8, 12, and 52.
Number of participants with detectable levels of T-cell subsets at weeks 8, 12, and 52.
Measured: Week 8, Week 12, and Week 52
Serum Concentrations of Brodalumab, Assessed at Weeks 4, 8, 10, 12, 16, 22, and 52.
Number of participants with detectable levels of brodalumab at weeks 4, 8, 10, 12, 16, 22, and 52.
Measured: Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52
Anti-tetanus Toxoid Antibodies ≥0.1 IU/mL, Assessed at Week 12.
Number of participants with detectable levels of anti-tetanus toxoid antibodies at weeks 12.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start7 Dec 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: Early terminated due to difficulty recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305327
- Sponsor's protocol ID
- LP0160-1396
- Other IDs
- 2019-001868-30, U1111-1282-4459, 2019
- Acronym
- EMBRACE 1
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2020
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04305327
- Acronym / sponsor ID
- EMBRACE 1 / LP0160-1396
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early terminated due to difficulty recruiting participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brodalumab | Experimental | Drug: BrodalumabBrodalumab for 52 weeks. The dose will be determined by the participant's body weight. |
| Ustekinumab | Active comparator | Drug: UstekinumabUstekinumab for 52 weeks. The dose will be determined by the participant's body weight. |
| Placebo/brodalumab | Placebo comparator | Drug: Brodalumab, Drug: PlaceboPlacebo for the first 12 weeks and brodalumab for the following 40 weeks. The dose will be determined by the participant's body weight. |
| Placebo/ustekinumab | Placebo comparator | Drug: Ustekinumab, Drug: PlaceboPlacebo for the first 12 weeks and ustekinumab for the following 40 weeks. The dose will be determined by the participant's body weight. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabAlso: Kyntheum®Solution for subcutaneous injection. | Drug | Brodalumab, Placebo/brodalumab |
| UstekinumabAlso: Stelara®Solution for subcutaneous injection. | Drug | Placebo/ustekinumab, Ustekinumab |
| PlaceboThe placebo solution is similar to the active brodalumab solution except that it does not contain any active substance. | Drug | Placebo/brodalumab, Placebo/ustekinumab |
Primary outcome
Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12.
Time frame: 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.
12 secondary outcomes
Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12.
Time frame: Week 12
sPGA Score of 0, Assessed at Week 12.
Time frame: Week 12
PASI 90 Response, Assessed at Week 12.
Time frame: Baseline to Week 12
PASI 100 Response, Assessed at Week 12.
Time frame: Baseline to Week 12
Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12.
Time frame: Week 12
Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12.
Time frame: Week 12
Overall Number of Adverse Events (AEs)
Time frame: Up to approximately 5 months
Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52.
Time frame: Week 4, Week 16, and Week 52
Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52.
Time frame: Week 8, Week 12, and Week 52
Blood Levels of T-cell Subsets (CD4+ and CD8+), Assessed at Weeks 8, 12, and 52.
Time frame: Week 8, Week 12, and Week 52
Serum Concentrations of Brodalumab, Assessed at Weeks 4, 8, 10, 12, 16, 22, and 52.
Time frame: Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52
Anti-tetanus Toxoid Antibodies ≥0.1 IU/mL, Assessed at Week 12.
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brodalumab and Ustekinumab in people with Psoriasis, run by LEO Pharma at 35 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, Poland, Spain, Greece, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.