Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

Psoriasis Vulgaris Clinical Trial

— ADJUST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306315
• Other study ID #: LP0160-1329
• Secondary ID: 2017-004998-13U1
• Status: Recruiting
• Phase: Phase 4
• Start date: July 18, 2022
• Est. completion date: January 8, 2026

Study information

• Verified date: June 2024
• Source: LEO Pharma
• Contact: Clincal Disclosure
• Phone: (+1) 877-557-1168
• Email: disclosure[@]leo-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: January 8, 2026
• Est. primary completion date: September 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Body Weight
• Psoriasis
• Psoriasis Vulgaris

Intervention

Biological:
• Brodalumab
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

Locations

Country	Name	City	State
Belgium	LEO Pharma Investigational Site	Brussels
Belgium	LEO Pharma Investigational Site	Ham-sur-Heure-Nalinnes
Belgium	LEO Pharma Investigational Site	Leuven
Belgium	LEO Pharma Investigational Site	Liège
Czechia	LEO Pharma Investigational Site	Kutná Hora
Czechia	LEO Pharma Investigational Site	Nový Jicín
Czechia	LEO Pharma Investigational Site	Plzen-Bory
France	LEO Pharma Investigational Site	Amiens	Somme
France	LEO Pharma Investigational Site	Saint-Priest-en-Jarez
France	LEO Pharma Investigational Site	Toulouse cedex 9
France	LEO Pharma Investigational Site	Valence
Germany	LEO Pharma Investigational Site	Bad Bentheim
Germany	LEO Pharma Investigational Site	Berlin	Berline
Germany	LEO Pharma Investigational Site	Bielefeld
Germany	LEO Pharma Investigational Site	Hamburg
Germany	LEO Pharma Investigational Site	Kiel	Schleswig-Holstein
Germany	LEO Pharma Investigational Site	Langenau	Baden-Wuerttemberg
Germany	LEO Pharma Investigational Site	Limburg	Hessen
Germany	LEO Pharma Investigational Site	Lohne	Lower Saxony
Germany	LEO Pharma Investigational Site	Mainz	Rheinland-Pfalz
Germany	LEO Pharma Investigational Site	Memmingen
Germany	LEO Pharma Investigational Site	Münster
Germany	LEO Pharma Investigational Site	Oldenburg
Germany	LEO Pharma Investigational Site	Osnabrück
Germany	LEO Pharma Investigational Site	Wiesbaden	Hessen
Greece	LEO Pharma Investigational Site	Athens
Greece	LEO Pharma Investigational Site	Athens
Greece	LEO Pharma Investigational Site	Heraklion	Crete
Greece	LEO Pharma Investigational Site	Piraeus
Greece	LEO Pharma Investigational Site	Thessaloníki
Greece	LEO Pharma Investigational Site	Thessaloníki
Greece	LEO Pharma Investigational Site	Thessaloníki
Hungary	LEO Pharma Investigational Site	Debrecen
Hungary	LEO Pharma Investigational Site	Orosháza
Hungary	LEO Pharma Investigational Site	Szolnok
Hungary	LEO Pharma Investigational Site	Veszprém
Italy	LEO Pharma Investigational Site	Ancona
Italy	LEO Pharma Investigational Site	Bologna
Italy	LEO Pharma Investigational Site	Brescia
Italy	LEO Pharma Investigational Site	Coppito
Italy	LEO Pharma Investigational Site	Modena
Italy	LEO Pharma Investigational Site	Napoli
Italy	LEO Pharma Investigational Site	Parma
Italy	LEO Pharma Investigational Site	Pavia
Italy	LEO Pharma Investigational Site	Roma
Italy	LEO Pharma Investigational Site	Roma
Italy	LEO Pharma Investigational Site	Rozzano
Netherlands	LEO Pharma Investigational Site	Beek
Poland	LEO Pharma Investigational Site	Iwonicz-Zdrój
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lublin
Poland	LEO Pharma Investigational Site	Lublin
Poland	LEO Pharma Investigational Site	Poznan
Poland	LEO Pharma Investigational Site	Skierniewice
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Wroclaw
Poland	LEO Pharma Investigational Site	Wroclaw
Poland	LEO Pharma Investigational Site	Wroclaw
Spain	LEO Pharma Investigational Site	Alicante
Spain	LEO Pharma Investigational Site	Badalona
Spain	LEO Pharma Investigational Site	Barcelona
Spain	LEO Pharma Investigational Site	Barcelona
Spain	LEO Pharma Investigational Site	Granada
Spain	LEO Pharma Investigational Site	Manises
Spain	LEO Pharma Investigational Site	Pontevedra
Spain	LEO Pharma Investigational Site	Pozuelo De Alarcón
Spain	LEO Pharma Investigational Site	Santiago De Compostela
Spain	LEO Pharma Investigational Site	Valencia
Spain	LEO Pharma Investigational Site	Villajoyosa
United Kingdom	LEO Pharma Investigational Site	Chorley
United Kingdom	LEO Pharma Investigational Site	Corby
United Kingdom	LEO Pharma Investigational Site	Corby
United Kingdom	LEO Pharma Investigational Site	Coventry
United Kingdom	LEO Pharma Investigational Site	Liverpool
United Kingdom	LEO Pharma Investigational Site	London
United Kingdom	LEO Pharma Investigational Site	London
United Kingdom	LEO Pharma Investigational Site	Northwood
United Kingdom	LEO Pharma Investigational Site	Shipley

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 40
Secondary	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).	Week 40
Secondary	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.	Week 52
Secondary	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).	Week 52
Secondary	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).	Week 40
Secondary	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).	Week 40
Secondary	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).	Week 52
Secondary	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.	Week 40
Secondary	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.	Week 52
Secondary	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.	Week 40 and 52
Secondary	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.	Week 40 and 52
Secondary	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.	Week 40
Secondary	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.	Week 52
Secondary	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.	Week 40 and 52
Secondary	Number of Participants Experiencing Adverse Events (AEs) up to Week 58.		Week 58