search
Back to results

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

Primary Purpose

Psoriasis Vulgaris

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Brodalumab
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)

Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2020
Last Updated
October 13, 2023
Sponsor
LEO Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT04306315
Brief Title
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
October 27, 2025 (Anticipated)
Study Completion Date
December 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The pre-filled syringes with 210 mg (1.5 mL) brodalumab will be open-label. The packaging and labelling of the pre-filled syringes with 70 mg (0.5 mL) brodalumab or placebo will contain no evidence to distinguish brodalumab from placebo. It is not considered possible to distinguish between brodalumab and placebo visually; both solutions are colourless.
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)
Arm Type
Experimental
Arm Description
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.
Arm Title
Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Brodalumab
Intervention Description
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.
Primary Outcome Measure Information:
Title
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
Description
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.
Time Frame
Week 40
Secondary Outcome Measure Information:
Title
Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40
Description
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).
Time Frame
Week 40
Title
Having PASI 90 response at Week 52
Description
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.
Time Frame
Week 52
Title
Having sPGA score of 0 or 1 at Week 52
Description
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).
Time Frame
Week 52
Title
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52
Description
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).
Time Frame
Week 40
Title
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40
Description
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).
Time Frame
Week 40
Title
Having sPGA-G score of 0 or 1 at Week 52
Description
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).
Time Frame
Week 52
Title
Having PASI 100 response at Week 40
Description
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.
Time Frame
Week 40
Title
Having PASI 100 response at Week 52
Description
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.
Time Frame
Week 52
Title
Change from baseline at Weeks 40 and 52 in PASI score
Description
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.
Time Frame
Week 40 and 52
Title
Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)
Description
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.
Time Frame
Week 40 and 52
Title
Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40
Description
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.
Time Frame
Week 40
Title
Having DLQI total score of 0 or 1 at Week 52
Description
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.
Time Frame
Week 52
Title
Change from baseline at Weeks 40 and 52 in DLQI total score
Description
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.
Time Frame
Week 40 and 52
Title
Number of Participants Experiencing Adverse Events (AEs) up to Week 58.
Time Frame
Week 58

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clincal Disclosure
Phone
(+1) 877-557-1168
Email
disclosure@leo-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Ham-sur-Heure-Nalinnes
ZIP/Postal Code
6120
Country
Belgium
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Kutná Hora
ZIP/Postal Code
284 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czechia
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Valence
ZIP/Postal Code
13616
Country
France
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Langenau
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89129
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Berlin
State/Province
Berline
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Limburg
State/Province
Hessen
ZIP/Postal Code
56242
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Lohne
State/Province
Lower Saxony
ZIP/Postal Code
49393
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55128
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Heraklion
State/Province
Crete
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Athens
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Athina
ZIP/Postal Code
115 25
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Pireas
ZIP/Postal Code
185 36
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Thessaloníki
ZIP/Postal Code
546 43
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Thessaloníki
ZIP/Postal Code
54643
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Thessaloníki
ZIP/Postal Code
56403
Country
Greece
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Orosháza
ZIP/Postal Code
5900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Coppito
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Iwonicz-Zdrój
ZIP/Postal Code
38-440
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Warszawa
ZIP/Postal Code
02-482
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Warszawa
ZIP/Postal Code
02-801
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Łódź
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
La Vila Joiosa
ZIP/Postal Code
03570
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Manises
ZIP/Postal Code
46940
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Pozuelo De Alarcón
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Corby
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Corby
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Coventry
ZIP/Postal Code
CV3 4FJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
London
ZIP/Postal Code
BR5 3QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Shipley
ZIP/Postal Code
BD18 35A
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data is available to request after results of the trial are available on leopharmatrials.com
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

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

We'll reach out to this number within 24 hrs