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

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ClinicalTrials.gov Identifier: NCT04306315
Recruitment Status : Not yet recruiting
First Posted : March 12, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
This study investigates if an increased dose of brodalumab will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dose will be compared to the standard dose of brodalumab plus placebo.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Biological: Brodalumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 6, 2025
Estimated Study Completion Date : November 14, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arm Intervention/treatment
Experimental: Brodalumab 210 mg + brodalumab 70 mg add-on*
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.
Biological: Brodalumab
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

Placebo Comparator: Brodalumab 210 mg + placebo add-on*
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.
Biological: Brodalumab
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.




Primary Outcome Measures :
  1. Having at least 90% lower Psoriasis Area and Severity Index (PASI) score [ 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 Outcome Measures :
  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.

  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 ]
    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.

  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.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 current active tuberculosis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306315


Contacts
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Contact: Clincal Disclosure (+1) 877-557-1168 disclosure@leo-pharma.com

Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT04306315    
Other Study ID Numbers: LP0160-1329
2017-004998-13 ( EudraCT Number )
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
URL: http://leopharmatrials.com/for-professionals

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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
Additional relevant MeSH terms:
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Psoriasis
Body Weight
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
Dermatologic Agents