A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
- Conditions
- Psoriasis Vulgaris
- Interventions
- Drug: Fumaric acid esters
- Registration Number
- NCT03331835
- Lead Sponsor
- LEO Pharma
- Brief Summary
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
- Detailed Description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fumaric acid esters Fumaric acid esters Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label. Brodalumab Brodalumab Kyntheum® (brodalumab) pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections. First 3 injections are administered weekly, and hereafter every two weeks (Q2W).
- Primary Outcome Measures
Name Time Method Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 Baseline to Week 24 The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 Baseline to Week 24 sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation.
Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
- Secondary Outcome Measures
Name Time Method Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) Week 24 The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Number of Symptom-free Days From Randomisation to Week 24 Baseline to Week 24 The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Burden of Symptoms Baseline to Week 24 Burden of symptoms was assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment. The AUC for the PSI total score was calculated for each participant using the standard trapezoidal rule. The AUC was normalised by dividing it with the time from baseline to the last available assessment of the PSI total score.
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms.Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 Baseline to Week 24 The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).Change From Baseline at Week 24 in PASI Score Baseline to Week 24 The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative change in PASI score means that the PASI score was lower at the time of data collection.DLQI Total Score of 0 or 1 at Week 24 Week 24 DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their QoL 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 QoL.
Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 Baseline to Week 24 The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).Percent Change From Baseline in PASI Score at Week 24 Baseline to Week 24 The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative value in the percent change from baseline that the PASI score was lower at the time of data collection.Change From Baseline at Week 24 in Affected Body Surface Area (BSA) Baseline to Week 24 The surface area of the participant's hand (palm and fingers) is used as a reference measurement to calculate the percentage of each body region that is affected by psoriasis. One hand is approximately equal to 1% total BSA.
Furthermore, the complete body surface area (BSA=100%) can be divided into regions that approximates percentages of BSA as follows: head and neck (10%), upper extremities (20%), the trunk including the axillae and groin (30%), and finally the lower extremities, including the buttocks (40%).
A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection.PSI Total Score of 0 at Week 24 Week 24 The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score Baseline to Week 24 DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life 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 QoL.
Trial Locations
- Locations (30)
Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum
🇩🇪Berlin, Germany
Fachklinik Bad Bentheim Klinik für Dermatologie
🇩🇪Bad Bentheim, Germany
Rothhaar Studien GmbH Dermatologisches Studienzentrum
🇩🇪Berlin, Germany
Hautarztpraxis Dr. Wildfeuer
🇩🇪Berlin, Germany
Klinikum Bielefeld Klinik für Dermatologie und Allergologie
🇩🇪Bielefeld, Germany
Hauttumorzentrum Ruhr- Universität im St. Josef Hospital
🇩🇪Bochum, Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus
🇩🇪Bochum, Germany
Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie
🇩🇪Bonn, Germany
Elbe Klinikum Buxtehude Klinik für Dermatologie
🇩🇪Buxtehude, Germany
Rosenpark Research
🇩🇪Darmstadt, Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
🇩🇪Dresden, Germany
Universitätsklinikum Erlangen Hautklinik
🇩🇪Erlangen, Germany
Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen
🇩🇪Hamburg, Germany
Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten
🇩🇪Gelsenkirchen, Germany
Derma-Study-Center-Friedrichshafen
🇩🇪Friedrichshafen, Germany
SCIderm GmbH
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie
🇩🇪Hannover, Germany
Universitäts-Hautklinik Heidelberg
🇩🇪Heidelberg, Germany
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum
🇩🇪Kiel, Germany
Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie
🇩🇪Mannheim, Germany
University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center
🇩🇪Mainz, Germany
Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie
🇩🇪München, Germany
KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie
🇩🇪Recklinghausen, Germany
Klinische Forschung Osnabrück - Klifos
🇩🇪Osnabrück, Germany
Gemeinschaftspraxis Weber & Crainic
🇩🇪Schweinfurt, Germany
Hautarztpraxis Dres. Leitz
🇩🇪Stuttgart, Germany
Hautarztpraxis
🇩🇪Witten, Germany
Universitätsklinikum Frankfurt Klinik für Dermatologie
🇩🇪Frankfurt, Germany
University Medical Center University of Tübingen
🇩🇪Tübingen, Germany