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Completed

NCT Number: NCT04306315

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose 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.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LEO Pharma Investigational Site, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brodalumab

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40

    Time frame: 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).

  2. Having PASI 90 response at Week 52

    Time frame: 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.

  3. Having sPGA score of 0 or 1 at Week 52

    Time frame: 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).

  4. Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52

    Time frame: Week 40 and 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).

  5. Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40

    Time frame: 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).

  6. Having sPGA-G score of 0 or 1 at Week 52

    Time frame: 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).

  7. Having PASI 100 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. PASI 100 is defined as 100% improvement in PASI relative to baseline.

  8. Having PASI 100 response at Week 52

    Time frame: 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.

  9. Change from baseline at Weeks 40 and 52 in PASI score

    Time frame: Week 40 and 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.

  10. Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)

    Time frame: Week 40 and 52

    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.

  11. Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40

    Time frame: 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.

  12. Having DLQI total score of 0 or 1 at Week 52

    Time frame: 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.

  13. Change from baseline at Weeks 40 and 52 in DLQI total score

    Time frame: Week 40 and 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 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.

  14. Number of Participants Experiencing Adverse Events (AEs) up to Week 58.

    Time frame: Week 58

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Acronym: ADJUST

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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