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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003867-21 | EudraCT Number |
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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.
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brodalumab | Experimental | 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). |
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| Fumaric acid esters | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Biological | Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA). Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at 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). | Baseline to Week 24 |
| Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at 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). | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 24 in NAPSI Total Score | The Nail Psoriasis Severity Index (NAPSI) grades nails by first dividing the nail area with imaginary horizontal and vertical lines into 4 quarters. The following 8 clinical features of nail psoriasis are then scored based on the number of quarters in which the feature is present (0 to 4) to arrive at a NAPSI score of 0 to 32 for each nail:
A negative change in NAPSI score means that the NAPSI score was lower at the time of data collection. |
Main Criteria for Inclusion:
Main Criteria for Exclusion:
Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
Previous or current PUVA (psoralens and ultraviolet A) therapy.
Washouts and non-permitted drugs:
Subjects with any of the following laboratory abnormalities at screening:
History of depressive disorder within the last 2 years including current antidepressive treatment.
Subjects with a history of suicidal behaviour (suicide attempt).
Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.
A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fachklinik Bad Bentheim Klinik für Dermatologie | Bad Bentheim | 48455 | Germany | |||
| Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Fumaric Acid Esters |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2018 |
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| Fumaric acid esters | Drug | Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects. |
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| Baseline to Week 24 |
| Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at 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). | Baseline to Week 24 |
| Change From Baseline at Week 24 in PASI Score | 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. | Baseline to Week 24 |
| Percent Change From Baseline in PASI Score at 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. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Affected Body Surface Area (BSA) | 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. | Baseline to Week 24 |
| Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) | 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. | Week 24 |
| PSI Total Score of 0 at 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. | Week 24 |
| Number of Symptom-free Days From Randomisation 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. | Baseline to Week 24 |
| Burden of Symptoms | 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. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score | 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. | Baseline to Week 24 |
| DLQI Total Score of 0 or 1 at 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. | Week 24 |
| Baseline to Week 24 |
| Berlin |
| 10117 |
| Germany |
| Rothhaar Studien GmbH Dermatologisches Studienzentrum | Berlin | 10783 | Germany |
| Hautarztpraxis Dr. Wildfeuer | Berlin | 13055 | Germany |
| Klinikum Bielefeld Klinik für Dermatologie und Allergologie | Bielefeld | 33647 | Germany |
| Hauttumorzentrum Ruhr- Universität im St. Josef Hospital | Bochum | 44791 | Germany |
| Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus | Bochum | 44793 | Germany |
| Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie | Bonn | 53127 | Germany |
| Elbe Klinikum Buxtehude Klinik für Dermatologie | Buxtehude | 21614 | Germany |
| Rosenpark Research | Darmstadt | 64283 | Germany |
| Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie | Dresden | 01307 | Germany |
| Universitätsklinikum Erlangen Hautklinik | Erlangen | 91054 | Germany |
| Universitätsklinikum Frankfurt Klinik für Dermatologie | Frankfurt | 60590 | Germany |
| Derma-Study-Center-Friedrichshafen | Friedrichshafen | 88045 | Germany |
| Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten | Gelsenkirchen | 45883 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen | Hamburg | 20246 | Germany |
| SCIderm GmbH | Hamburg | 20354 | Germany |
| Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie | Hanover | 30625 | Germany |
| Universitäts-Hautklinik Heidelberg | Heidelberg | 69120 | Germany |
| Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum | Kiel | 24105 | Germany |
| Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie | Mannheim | 68167 | Germany |
| Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie | München | 80802 | Germany |
| Klinische Forschung Osnabrück - Klifos | Osnabrück | 49074 | Germany |
| KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie | Recklinghausen | 45657 | Germany |
| Gemeinschaftspraxis Weber & Crainic | Schweinfurt | 97421 | Germany |
| Hautarztpraxis Dres. Leitz | Stuttgart | 70178 | Germany |
| University Medical Center University of Tübingen | Tübingen | 72076 | Germany |
| Hautarztpraxis | Witten | 58453 | Germany |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brodalumab | Subcutaneous (s.c.) brodalumab 210 mg once weekly at Weeks 0, 1, and 2, and 210 mg s.c. every 2 weeks. |
| BG001 | Fumaric Acid Esters | Oral fumaric acid esters up to 240 mg 3 times daily (TID). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Mean weight in participants weighing <100 kg | Not all participants weighed below 100 kg. This section shows the mean weight of participants weighing less than 100 kg. | Mean | Standard Deviation | kg |
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| Mean weight in participants weighing >=100 kg | Not all participants weighed over 100 kg. This section shows the mean weight of participants equal to or more than 100 kg | Mean | Standard Deviation | kg |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Duration of psoriasis | Mean | Standard Deviation | years |
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| PASI score | The psoriasis area and severity index (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 scaliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). | Mean | Standard Deviation | score on a scale |
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| sPGA score | The static Physicians Global Assessment (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). | Mean | Standard Deviation | score on a scale |
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| BSA score | Mean | Standard Deviation | score on a scale |
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| NAPSI score | The Nail Psoriasis Severity Index (NAPSI) grades nails by dividing the nail area into 4 quarters. The following 8 clinical features of nail psoriasis are then scored based on the number of quarters in which the feature is present (0 to 4) to arrive at a NAPSI score of 0 to 32 for each nail:
A negative change in NAPSI score means that the NAPSI score was lower at the time of data collection. | Not all participants had nail involvement at baseline. Only participants with nail involvement at baseline were included here. | Mean | Standard Deviation | score on a scale |
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| DLQI score | The Dermatology Life Quality Index (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. | Mean | Standard Deviation | score on a scale |
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| PSI score | The Psoriasis Symptom Inventory (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. | Not all subjects had a baseline PSI measurement. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at 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). | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Primary | Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at 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). | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at 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). | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at 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). | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in PASI Score | 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. | The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint. | Posted | Mean | Standard Error | score on a scale | Baseline to Week 24 |
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| Secondary | Percent Change From Baseline in PASI Score at 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. | The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint. | Posted | Mean | Standard Error | percent change in PASI | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Affected Body Surface Area (BSA) | 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. | Posted | Mean | Standard Error | percent change | Baseline to Week 24 |
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| Secondary | Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) | 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. | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | PSI Total Score of 0 at 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. | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Number of Symptom-free Days From Randomisation 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. | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. | Posted | Mean | Standard Deviation | days | Baseline to Week 24 |
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| Secondary | Burden of Symptoms | 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. | Not all participants had recorded PSI data, therefore the analysed number of participants is lower than the randomised number of participants. | Posted | Mean | Standard Error | score on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score | 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. | The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint. | Posted | Mean | Standard Error | score on a scale | Baseline to Week 24 |
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| Secondary | DLQI Total Score of 0 or 1 at 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. | Posted | Count of Participants | Participants | Week 24 |
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| Other Pre-specified | Change From Baseline at Week 24 in NAPSI Total Score | The Nail Psoriasis Severity Index (NAPSI) grades nails by first dividing the nail area with imaginary horizontal and vertical lines into 4 quarters. The following 8 clinical features of nail psoriasis are then scored based on the number of quarters in which the feature is present (0 to 4) to arrive at a NAPSI score of 0 to 32 for each nail:
A negative change in NAPSI score means that the NAPSI score was lower at the time of data collection. | Only participants with nail involvement at baseline were included in the analysis. Therefore the number of analysed participants differs from the number of randomised participants. | Posted | Mean | Standard Error | score on a scale | Baseline to Week 24 |
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From the first day of investigational medicinal product (IMP) administration and until 32 weeks later for brodalumab and 26 weeks later for fumaric acid esters. The difference in collection periods was due to the different half-lives of the IMPs.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brodalumab 210 mg | 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). | 0 | 104 | 3 | 104 | 66 | 104 |
| EG001 | Fumaric Acid Ester | 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. | 0 | 102 | 1 | 102 | 90 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Reactive gastropathy | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
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| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
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Operational challenges with the ePRO diary device given to trial participants led to missing data at baseline and Week 24. This made the analyses of the secondary patient-reported endpoints PSI response rate and PSI total score of 0 or 1 impossible.
The investigators have agreed to refrain from publishing based on data from this trial until the multi-center publication containing data from all sites has been published (usually after approx. 18 months). After this, any publication by individual investigators must be reviewed by the sponsor prior to submission. Sponsor has the right to remove any commercially confidential information and/or delay the publication up to 4 months to allow time for activities protecting intellectual rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma AS | (+1) 877-557-1168 | disclosure@leo-pharma.com |
| Jan 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C571216 | brodalumab |
| D005650 | Fumarates |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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