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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004998-13 | EudraCT Number | ||
| U1111-1282-4507 | Other Identifier | World Health Organization (WHO) | |
| 2023-509668-11-00 | EU Trial (CTIS) Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Biological | Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Having PASI 90 response at Week 52 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Brussels | 1200 | Belgium | |||
| LEO Pharma Investigational Site |
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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.
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 |
| 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 |
| 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 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 40 and 52 |
| Number of Participants Experiencing Adverse Events (AEs) up to Week 58. | Week 58 |
| Ham-sur-Heure-Nalinnes |
| 6120 |
| Belgium |
| LEO Pharma Investigational Site | Leuven | 3000 | Belgium |
| LEO Pharma Investigational Site | Liège | B-4000 | Belgium |
| LEO Pharma Investigational Site | Kutná Hora | 284 01 | Czechia |
| LEO Pharma Investigational Site | Nový Jičín | 741 01 | Czechia |
| LEO Pharma Investigational Site | Plzen-Bory | 305 99 | Czechia |
| LEO Pharma Investigational Site | Amiens | Somme | 80054 | France |
| LEO Pharma Investigational Site | Saint-Priest-en-Jarez | 42270 | France |
| LEO Pharma Investigational Site | Toulouse | 31059 | France |
| LEO Pharma Investigational Site | Valence | 13616 | France |
| LEO Pharma Investigational Site | Langenau | Baden-Wurttemberg | 89129 | Germany |
| LEO Pharma Investigational Site | Limburg an der Lahn | Hesse | 56242 | Germany |
| LEO Pharma Investigational Site | Wiesbaden | Hesse | 65189 | Germany |
| LEO Pharma Investigational Site | Lohne | Lower Saxony | 49393 | Germany |
| LEO Pharma Investigational Site | Mainz | Rhineland-Palatinate | 55128 | Germany |
| LEO Pharma Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| LEO Pharma Investigational Site | Berlin | State of Berlin | 10117 | Germany |
| LEO Pharma Investigational Site | Bad Bentheim | 48455 | Germany |
| LEO Pharma Investigational Site | Bielefeld | 33647 | Germany |
| LEO Pharma Investigational Site | Hamburg | 20246 | Germany |
| LEO Pharma Investigational Site | Memmingen | 87700 | Germany |
| LEO Pharma Investigational Site | Münster | 48149 | Germany |
| LEO Pharma Investigational Site | Oldenburg | 26133 | Germany |
| LEO Pharma Investigational Site | Osnabrück | 49074 | Germany |
| LEO Pharma Investigational Site | Heraklion | Crete | 711 10 | Greece |
| LEO Pharma Investigational Site | Athens | 115 25 | Greece |
| LEO Pharma Investigational Site | Athens | 16121 | Greece |
| LEO Pharma Investigational Site | Piraeus | 185 36 | Greece |
| LEO Pharma Investigational Site | Thessaloniki | 546 43 | Greece |
| LEO Pharma Investigational Site | Thessaloniki | 54643 | Greece |
| LEO Pharma Investigational Site | Thessaloniki | 56403 | Greece |
| LEO Pharma Investigational Site | Debrecen | 4032 | Hungary |
| LEO Pharma Investigational Site | Orosháza | 5900 | Hungary |
| LEO Pharma Investigational Site | Szolnok | 5000 | Hungary |
| LEO Pharma Investigational Site | Veszprém | 8200 | Hungary |
| LEO Pharma Investigational Site | Ancona | 60020 | Italy |
| LEO Pharma Investigational Site | Bologna | 40138 | Italy |
| LEO Pharma Investigational Site | Brescia | 25123 | Italy |
| LEO Pharma Investigational Site | Coppito | 67100 | Italy |
| LEO Pharma Investigational Site | Modena | 41124 | Italy |
| LEO Pharma Investigational Site | Naples | 80131 | Italy |
| LEO Pharma Investigational Site | Parma | 43126 | Italy |
| LEO Pharma Investigational Site | Pavia | 27100 | Italy |
| LEO Pharma Investigational Site | Roma | 00133 | Italy |
| LEO Pharma Investigational Site | Roma | 00168 | Italy |
| LEO Pharma Investigational Site | Rozzano | 20089 | Italy |
| LEO Pharma Investigational Site | Beek | 6191 JW | Netherlands |
| LEO Pharma Investigational Site | Iwonicz-Zdrój | 38-440 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-242 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-436 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-362 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-412 | Poland |
| LEO Pharma Investigational Site | Poznan | 60-529 | Poland |
| LEO Pharma Investigational Site | Skierniewice | 96-100 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-482 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-758 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-801 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 50-566 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-318 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 52-416 | Poland |
| LEO Pharma Investigational Site | Alicante | 03010 | Spain |
| LEO Pharma Investigational Site | Badalona | 08916 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08025 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08035 | Spain |
| LEO Pharma Investigational Site | Granada | 18014 | Spain |
| LEO Pharma Investigational Site | Manises | 46940 | Spain |
| LEO Pharma Investigational Site | Pontevedra | 36001 | Spain |
| LEO Pharma Investigational Site | Pozuelo de Alarcón | 28223 | Spain |
| LEO Pharma Investigational Site | Santiago de Compostela | 15706 | Spain |
| LEO Pharma Investigational Site | Valencia | 46014 | Spain |
| LEO Pharma Investigational Site | Villajoyosa | 03570 | Spain |
| LEO Pharma Investigational Site | Chorley | PR7 7NA | United Kingdom |
| LEO Pharma Investigational Site | Corby | NN17 2UR | United Kingdom |
| LEO Pharma Investigational Site | Corby | NN18 9EZ | United Kingdom |
| LEO Pharma Investigational Site | Coventry | CV3 4FJ | United Kingdom |
| LEO Pharma Investigational Site | Liverpool | L22 0LG | United Kingdom |
| LEO Pharma Investigational Site | London | BR5 3QG | United Kingdom |
| LEO Pharma Investigational Site | London | E1 2ES | United Kingdom |
| LEO Pharma Investigational Site | Northwood | HA6 2RN | United Kingdom |
| LEO Pharma Investigational Site | Shipley | BD18 35A | United Kingdom |
| ID | Term |
|---|---|
| C571216 | brodalumab |
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