Psoriasis VulgarisPhase 4ADJUSTNCT04306315
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
A Phase 4 study testing Brodalumab in people with Psoriasis Vulgaris, run by LEO Pharma at 81 sites in 11 countries.
Trial summary
This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 81 sitesin 11 countries
- Study dates
- 21 Jul 2022to 5 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Age ≥18 to <75 years at the time of screening.
- Diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
- Body weight ≥120 kg at the time of screening.
- Moderate-to-severe plaque psoriasis as defined by: BSA ≥10% and PASI ≥12 at screening and baseline.
- No evidence of active or latent tuberculosis according to local standard of care.
Who cannot join
- Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of the investigational medicinal product (IMP) on participants with plaque psoriasis.
- Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C).
- Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the participants and/or placing the participant at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia).
- History of Crohn's disease.
- Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months.
- Any active malignancy.
Show all 10Show fewer
- History of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
- History of suicidal behaviour (i.e., 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or at baseline.
- Any suicidal ideation of category 4 or 5 ('active suicidal ideation with some intent to act, without specific plan' or ' active suicidal ideation with specific plan and intent') based on the C-SSRS questionnaire at screening or at baseline.
- A Patient Health Questionnaire (PHQ)-8 score of ≥10 corresponding to moderate-to-severe depression at screening or at baseline.
Trial locations and contacts
81 sites in 11 countries.
81 sites in 11 countries
Germany14 sites
LEO Pharma Investigational Site
Bad Bentheim, 48455
LEO Pharma Investigational Site
Berlin, State of Berlin, 10117
LEO Pharma Investigational Site
Bielefeld, 33647
LEO Pharma Investigational Site
Hamburg, 20246
LEO Pharma Investigational Site
Kiel, Schleswig-Holstein, 24105
LEO Pharma Investigational Site
Langenau, Baden-Wurttemberg, 89129
LEO Pharma Investigational Site
Limburg an der Lahn, Hesse, 56242
LEO Pharma Investigational Site
Lohne, Lower Saxony, 49393
LEO Pharma Investigational Site
Mainz, Rhineland-Palatinate, 55128
LEO Pharma Investigational Site
Memmingen, 87700
LEO Pharma Investigational Site
Münster, 48149
LEO Pharma Investigational Site
Oldenburg, 26133
LEO Pharma Investigational Site
Osnabrück, 49074
LEO Pharma Investigational Site
Wiesbaden, Hesse, 65189
Poland13 sites
LEO Pharma Investigational Site
Iwonicz-Zdrój, 38-440
LEO Pharma Investigational Site
Lodz, 90-242
LEO Pharma Investigational Site
Lodz, 90-436
LEO Pharma Investigational Site
Lublin, 20-362
LEO Pharma Investigational Site
Lublin, 20-412
LEO Pharma Investigational Site
Poznan, 60-529
LEO Pharma Investigational Site
Skierniewice, 96-100
LEO Pharma Investigational Site
Warsaw, 02-482
LEO Pharma Investigational Site
Warsaw, 02-758
LEO Pharma Investigational Site
Warsaw, 02-801
LEO Pharma Investigational Site
Wroclaw, 50-566
LEO Pharma Investigational Site
Wroclaw, 51-318
LEO Pharma Investigational Site
Wroclaw, 52-416
Italy11 sites
LEO Pharma Investigational Site
Ancona, 60020
LEO Pharma Investigational Site
Bologna, 40138
LEO Pharma Investigational Site
Brescia, 25123
LEO Pharma Investigational Site
Coppito, 67100
LEO Pharma Investigational Site
Modena, 41124
LEO Pharma Investigational Site
Naples, 80131
LEO Pharma Investigational Site
Parma, 43126
LEO Pharma Investigational Site
Pavia, 27100
LEO Pharma Investigational Site
Roma, 00133
LEO Pharma Investigational Site
Roma, 00168
LEO Pharma Investigational Site
Rozzano, 20089
Spain11 sites
LEO Pharma Investigational Site
Alicante, 03010
LEO Pharma Investigational Site
Badalona, 08916
LEO Pharma Investigational Site
Barcelona, 08025
LEO Pharma Investigational Site
Barcelona, 08035
LEO Pharma Investigational Site
Granada, 18014
LEO Pharma Investigational Site
Manises, 46940
LEO Pharma Investigational Site
Pontevedra, 36001
LEO Pharma Investigational Site
Pozuelo de Alarcón, 28223
LEO Pharma Investigational Site
Santiago de Compostela, 15706
LEO Pharma Investigational Site
Valencia, 46014
LEO Pharma Investigational Site
Villajoyosa, 03570
United Kingdom9 sites
LEO Pharma Investigational Site
Chorley, PR7 7NA
LEO Pharma Investigational Site
Corby, NN17 2UR
LEO Pharma Investigational Site
Corby, NN18 9EZ
LEO Pharma Investigational Site
Coventry, CV3 4FJ
LEO Pharma Investigational Site
Liverpool, L22 0LG
LEO Pharma Investigational Site
London, BR5 3QG
LEO Pharma Investigational Site
London, E1 2ES
LEO Pharma Investigational Site
Northwood, HA6 2RN
LEO Pharma Investigational Site
Shipley, BD18 35A
Greece7 sites
LEO Pharma Investigational Site
Athens, 115 25
LEO Pharma Investigational Site
Athens, 16121
LEO Pharma Investigational Site
Heraklion, Crete, 711 10
LEO Pharma Investigational Site
Piraeus, 185 36
LEO Pharma Investigational Site
Thessaloniki, 546 43
LEO Pharma Investigational Site
Thessaloniki, 54643
LEO Pharma Investigational Site
Thessaloniki, 56403
Belgium4 sites
LEO Pharma Investigational Site
Brussels, 1200
LEO Pharma Investigational Site
Ham-sur-Heure-Nalinnes, 6120
LEO Pharma Investigational Site
Leuven, 3000
LEO Pharma Investigational Site
Liège, B-4000
France4 sites
LEO Pharma Investigational Site
Amiens, Somme, 80054
LEO Pharma Investigational Site
Saint-Priest-en-Jarez, 42270
LEO Pharma Investigational Site
Toulouse, 31059
LEO Pharma Investigational Site
Valence, 13616
Hungary4 sites
LEO Pharma Investigational Site
Debrecen, 4032
LEO Pharma Investigational Site
Orosháza, 5900
LEO Pharma Investigational Site
Szolnok, 5000
LEO Pharma Investigational Site
Veszprém, 8200
Czechia3 sites
LEO Pharma Investigational Site
Kutná Hora, 284 01
LEO Pharma Investigational Site
Nový Jičín, 741 01
LEO Pharma Investigational Site
Plzen-Bory, 305 99
About this study
Official title: Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.
Read the detailed description
Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodalumab in clinical studies. Therefore, the purpose of this study is to investigate if increasing the dose of brodalumab will increase the effect of treatment for patients with a higher body weight. The study will run over 60-62 weeks, including screening, treatment period and safety follow-up, with the primary endpoint measurement at Week 40. Patients will receive subcutaneous injections of brodalumab at Week 0, 1, and 2, followed by injections every 2 weeks. Participants not fulfilling a predefined response at any time after Week 16 will receive a dose adjustment to 280 mg brodalumab or 210 mg brodalumab plus placebo every 2 weeks.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Brodalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabBiological
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen) | Experimental | Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any visit with efficacy assessments after Week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks. Receives: Biological: Brodalumab |
| Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment) | Placebo comparator | Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any time visit with efficacy assessments Week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks. Receives: Biological: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
Measured: Week 40
Secondary outcomes (14)
Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40
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).
Measured: Week 40
Having PASI 90 response at Week 52
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 90 is defined as at least 90% improvement in PASI relative to baseline.
Measured: Week 52
Having sPGA score of 0 or 1 at Week 52
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).
Measured: Week 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Measured: Week 40 and 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Measured: Week 40
Having sPGA-G score of 0 or 1 at Week 52
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Measured: Week 52
Having PASI 100 response at Week 40
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 100 is defined as 100% improvement in PASI relative to baseline.
Measured: Week 40
Having PASI 100 response at Week 52
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 100 is defined as 100% improvement in PASI relative to baseline.
Measured: Week 52
Change from baseline at Weeks 40 and 52 in PASI score
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
Measured: Week 40 and 52
Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)
To assess the full BSA with psoriatic involvement, the investigator will use the surface area of the participant's hand (palm and fingers) as a reference measurement to determine the percentage of the body surface area that is affected by psoriasis. One hand is approximately equal to 1% total BSA.
Measured: Week 40 and 52
Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their HQoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HQoL.
Measured: Week 40
Having DLQI total score of 0 or 1 at Week 52
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their HQoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HQoL.
Measured: Week 52
Change from baseline at Weeks 40 and 52 in DLQI total score
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life (HrQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment (10). Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HrQoL.
Measured: Week 40 and 52
Number of Participants Experiencing Adverse Events (AEs) up to Week 58.
Measured: Week 58
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 start21 Jul 2022
- Primary completion25 Aug 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306315
- Sponsor's protocol ID
- LP0160-1329
- Other IDs
- 2017-004998-13, U1111-1282-4507, 2023-509668-11-00, 2023, 2017
- Acronym
- ADJUST
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2020
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
- ClinicalTrials.gov ID
- NCT04306315
- Acronym / sponsor ID
- ADJUST / LP0160-1329
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.
Detailed description
Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodalumab in clinical studies. Therefore, the purpose of this study is to investigate if increasing the dose of brodalumab will increase the effect of treatment for patients with a higher body weight. The study will run over 60-62 weeks, including screening, treatment period and safety follow-up, with the primary endpoint measurement at Week 40. Patients will receive subcutaneous injections of brodalumab at Week 0, 1, and 2, followed by injections every 2 weeks. Participants not fulfilling a predefined response at any time after Week 16 will receive a dose adjustment to 280 mg brodalumab or 210 mg brodalumab plus placebo every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen) | Experimental | Biological: BrodalumabParticipants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any visit with efficacy assessments after Week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks. |
| Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment) | Placebo comparator | Biological: BrodalumabParticipants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any time visit with efficacy assessments Week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Age ≥18 to <75 years at the time of screening.
- Diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
- Body weight ≥120 kg at the time of screening.
- Moderate-to-severe plaque psoriasis as defined by: BSA ≥10% and PASI ≥12 at screening and baseline.
Key exclusion criteria (10 listed)
- Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of the investigational medicinal product (IMP) on participants with plaque psoriasis.
- Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C).
- Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the participants and/or placing the participant at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia).
- History of Crohn's disease.
- Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months.
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 |
|---|---|---|
| BrodalumabBrodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin. | Biological | Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen), Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment) |
Primary outcome
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
Time frame: Week 40
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess 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, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
14 secondary outcomes
Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40
Time frame: Week 40
Having PASI 90 response at Week 52
Time frame: Week 52
Having sPGA score of 0 or 1 at Week 52
Time frame: Week 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52
Time frame: Week 40 and 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40
Time frame: Week 40
Having sPGA-G score of 0 or 1 at Week 52
Time frame: Week 52
Having PASI 100 response at Week 40
Time frame: Week 40
Having PASI 100 response at Week 52
Time frame: Week 52
Change from baseline at Weeks 40 and 52 in PASI score
Time frame: Week 40 and 52
Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)
Time frame: Week 40 and 52
Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40
Time frame: Week 40
Having DLQI total score of 0 or 1 at Week 52
Time frame: Week 52
Change from baseline at Weeks 40 and 52 in DLQI total score
Time frame: Week 40 and 52
Number of Participants Experiencing Adverse Events (AEs) up to Week 58.
Time frame: Week 58
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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 Medical Expert study director
LEO Pharma
81 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brodalumab in people with Psoriasis Vulgaris, run by LEO Pharma at 81 sites in 11 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 6 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: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Germany, Poland, Italy, Spain, United Kingdom and 6 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40. (time frame: Week 40). 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 24 Apr 2026.